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SMEs: don’t let your problems get any worse! Take action using problem-solving methodology As a quality consultant, I’ve often observed the same thing: when faced with an incident, many companies react in a hurry. Directors and managers go into ‘fire brigade’ mode, putting out the fire with temporary solutions… until the next problem arises.But this management style leaves little room for anticipation. You have to chase after solutions while managing the consequences: customer complaints, delays, team stress, errors, financial losses… A real domino effect.If this situation sounds familiar, you know that it’s more comfortable – and more efficient – to avoid this vicious circle.Problems are inevitable in the life of a company, but they can become opportunities. How can they become opportunities? By adopting a problem-solving methodology.Based on an analysis of the causes, this approach enables you to : structure the way you act ; analyse the data ; anticipate situations; make better decisions. In this article, I present the main stages of this approach to help you take action, simply and effectively. IN SUMMARY If your company suffers from recurring problems, you need to implement a method for identifying the root causes and putting in place lasting solutions. Specific tools (Ishikawa, 5P, 8D, CAPA, etc.) are designed to lead to effective resolution. The secret is to structure your approach so that you don’t get stuck: mobilise your teams and measure your progress. Improve your performance: the complete problem-solving approach is the key to your success. Solving business problems with the 8D method Originating in the automotive industry, the 8D method (‘D’ for ‘Disciplines’) proposes a structured approach in 8 steps to effectively deal with malfunctions: D1: Creation of a team dedicated to solving the problem. D2: Description of the problem. D3: Implementation of remedial actions to correct the problem immediately. D4 : Identification of the root cause. D5 : Definition of corrective actions. D6 : Checking the effectiveness of the actions. D7 : Preventive actions. D8: Closing and congratulating the team. Describe the problem using 5W1H method No, I haven’t fallen asleep on my keyboard! This strange acronym refers to the series of questions you need to ask yourself to define a problem precisely. It’s an essential step to take to clearly define the problem before trying to solve it. Let’s take a look at the method through a concrete example: Context: a pharmaceutical company has noticed an increase in the number of adverse reaction reports concerning a batch of medicines. Application of the 5W1H method: Who? Patients who have taken the batch of drugs. What? Increase in complaints (undesirable side effects, lack of efficacy, etc.). Where? In several regions, following the distribution of a batch of medicines. When? Since the batch was placed on the market 3 months ago. How? Analysis of complaints, laboratory tests on samples of the batch. How many? 150 complaints received, potential impact on brand image and risk of regulatory sanctions. Why? (After investigation) Manufacturing defect during packaging of the batch, leading to contamination of the medicine. Take remedial action and analyse the root cause It’s only once you’ve done this that you can stop the bleeding by taking remedial action. But the work doesn’t stop there! The next step is to identify the root cause(s). This approach is known as ‘RCA’ (Root Cause Analysis). To carry out this search effectively, you can draw on 3 tried and tested tools: The Ishikawa diagram (also known as the 5M or fishbone diagram) This representation classifies the causes according to five criteria: Manpower  Machines  Materials  Methods  Measurement  These items form the basis of the 5M classification. Depending on the context, you can add your own categories. Diagramme d’Ishikawa — Infographie LUGAN CONSULTING. 5 Whys This questioning strategy, known as ‘5P’, is similar to the question loops used by young children. The difference is that, applied to the context we’re interested in, it’s an unstoppable way of getting to the root cause. An example of a concrete situation would be : Decision tree This tool is a visual diagram that allows you to explore several options when faced with a problem, evaluating the possible consequences, risks and benefits of each choice. It helps you make the most rational decision appropriate to the situation. These 3 problem-solving tools offer a number of advantages: Rapid reaction: rapid collection of essential information to understand the extent of the problem and take corrective action. Risk control: by identifying the root cause of the problem, the company can limit the impact. This approach is included in risk analysis. Continuous improvement: by analysing the causes, preventive action can be taken to improve processes. MASTER PROBLEM-SOLVING METHODOLOGY LUGAN CONSULTING offers specific training courses tailored to your industrial environment: train your teams in problem-solving methodology and get them involved! Ask us Eradicating the problem with the CAPA method Once the cause(s) have been determined, it’s time to get out of the infernal loop! This is the time to define a corrective action plan to avoid errors recurring. To make the task easier, you can use the CAPA (Corrective And Preventive Actions) method, a tool based on the requirements of ISO 9001. This process aims both to correct the immediate situation and to anticipate the implementation of measures to avoid the problem recurring. It breaks down into two types of action: Corrective Action : It is implemented with the aim of eliminating the recurrence of the problem. In practical terms, this involves a detailed action plan describing the steps to be taken to deal with the problem. This practical implementation also enables you to check the effectiveness of the actions taken on the ground. Measure efficiency by defining KPIs (performance indicators) to assess how the situation is evolving. Preventive action : It is defined in order to eliminate the occurrence, i.e. the probability of an event occurring. In practical terms, this means implementing the same preventive actions wherever there is a similar risk. Preventive action is based on anticipating critical scenarios and developing the corresponding preventive

PCM : PROCESS COMMUNICATION MODEL® Process Communication Model® (PCM) is a relationship management tool. Its principle? To understand how we work so that we can better understand our relationships and interactions with others. Applied to the business world, the Process Communication Model enables team members to get to know each other better so that they can work together more effectively. As an accredited PCM coach, I support all teams based on the precepts of this tool, as its scope of application is extremely broad. Here’s a look at how it works. Origin of PCM PCM is a model for discovering and understanding your own personality and that of others. ‘Designed to be as profound as it is simple, it opens up avenues for reflection and progress in order to be better with oneself and with others’ – Taibi Kahler Taibi Kahler, an American psychotherapist and transactional analyst, is the creator of the PCM model. He designed it based on the first observations he made in the 1970s, which he then modelled in 1982. The applications he made of it, during the 90s, with NASA and the Clinton administration have made it an essential tool in personal development and team coaching. A TOOL USED BY VIP’s NASA and the Clinton administration are two examples of VIP users of PCM. In the 1990s, the tool enabled them to harmonise relations between members of teams overseeing major missions. Piloting shuttles and remaining confined in space in the service of space research for one, and deciding the fate of an entire country, or even the world, for the other. That’s what it’s all about! PCM’s 6 Types of Personality PCM identifies six Personality Types, each representing a unique facet of human nature. These profiles, represented by colours, combine in a unique way in each individual, creating a veritable kaleidoscope of behaviours. Each Personality Type has : Character Strengths; Perceptions; Management Styles; Channels of Communications; Personality Parts; Psychological Motivators/Stressors; Degrees of distress. rofiles are made up of all personality types and are characterised by a Base (the foundation of our personality) that is unique to us. It constitutes our mode of Perception and reflects our Channels of Communication. This is how basic people are,   Thinker are organised, responsible and logical. They excel at managing projects, organising tasks, planning, etc. They are good at summarising. Persister are rigorous, conscientious, committed and able to assert their opinions and beliefs. They assess people and situations according to their opinions. Harmonizer sare caring, warm, compassionate and sensitive. Attentive and concerned about the well-being of others, they are the glue that holds the team together. They foster harmony and cooperation. They feel things first, perceiving people and situations through their emotions. Imaginer are calm, thoughtful and imaginative. They like to explore new avenues and challenge conventional wisdom. They take the long view. Gifted with a capacity for introspection, they are generally very good at work requiring dexterity and imagination. Rebel sare creative, playful and spontaneous. They are the driving force behind innovation, because they love new ideas and stimulating projects. Energetic, direct and daring, they like to shake things up and are often the instigators of radical change. They are able to see things with a sense of humour and appreciate the present moment.. Promoter are dynamic, charming, resourceful and adaptable. They are results-oriented and driven by competitiveness and action. Gifted with the ability to take decisions quickly and to be firm and direct, they enjoy taking on challenges and achieving their goals. Understanding these specific characteristics means you can adapt your behaviour to suit the person you are talking to and foster more effective communication. Base and Phase The result of a PCM personality inventory takes the form of a coloured house with six floors. Each colour corresponds to a specific personality profile. The more a colour is present, the more pronounced the associated character trait is in the individual. The base of the house represents the foundation of our personality: that which is built up in childhood and changes little over the course of our lives. This is ‘The Base’. It defines our fundamental way of functioning, the one that influences the way we perceive the world and interact with others. Another characteristic of our profile is what PCM calls ‘The Phase’. It reflects our current state, our psychological needs. This aspect of our personality is evolutionary and can change over the course of our lives, depending on our experiences and our environment. During our team-building sessions, we analyse these individual profiles in detail. This gives us a better understanding of each person’s strengths and needs, as well as how they interact within the group. The aim is to improve interpersonal communication by learning to adapt our behaviour to the profiles of our colleagues, particularly in stressful situations. The PCM model reveals that : We all have Personality Types within us. We hear and communicate with our Base. Our Phase reflects our need for motivation (psychological needs). Resource and supply mechanisms Each personality profile has its own resource and nourishment mechanisms, i.e. elements that enable it to recharge and maintain an optimal energy level. For example, people with an Analyzer base will find their resources in organisation, planning and carrying out meticulous tasks. They will feel valued when they have completed a task flawlessly (perfectly). Conversely, a Promoter Base person will need novelty, challenges and autonomy to feel stimulated. An overly structured environment or repetitive tasks can quickly demotivate them. Understanding these mechanisms is essential to creating a working environment where everyone feels valued and motivated. WHEN THE MASKS COME OFF When we are under stress, our defence mechanisms are triggered and we tend to adopt more instinctive behaviour. In the PCM world, we call these ‘Masks’. They reveal aspects of our personality that we don’t usually use and that can sometimes be at odds with our usual behaviour. Typically, a person with a :   Thinker may become fussy, no longer accepting delegation and over-controlling. Persister may become critical,

THE LONG-TERM IMPACT OF COACHING ON MANAGERS AND EXECUTIVES Sarah is a manager recently promoted to a senior position in a struggling company. Since her arrival, she has found herself faced with a demoralized team, outdated processes and a corporate culture resistant to change. Despite her skills, Sarah feels overwhelmed by the scale of the task and doubts her ability to carry out her mission. Sarah is a fictional character, created for this article (yes, I’m a Doctor Frankenstein in my spare time!), but the situation she finds herself in is that of many managers. It may even be the one you’re in right now… I meet Sarahs every day. At least, those who have decided to draw on the resources of a coach to support them in the challenges they face. Coaching has become a recognized tool for the professional development of managers and executives. Far beyond the immediate benefits, this personalized approach has lasting repercussions on the careers and even individual development of these leaders. Let’s take a closer look at the long-term impact of coaching. SUSTAINABLE DEVELOPMENT OF LEADERSHIP SKILLS   Coaching enables line managers to acquire and strengthen essential leadership skills. Once integrated, they become an integral part of their professional arsenal. Key skills developed include : Effective communication: communicating ideas clearly and inspiring teams. Strategic decision-making: quickly assess options and choose the best course of action. Managing diverse teams: adapt your management style to different personalities and team dynamics. Conflict resolution: deal with disagreements diplomatically and effectively. These enhanced skills will enable managers and executives to excel in their future missions, whatever the organizational context. IMPROVING RESILIENCE AND ADAPTABILITY How can you stand up to the ever-changing world of business? Thanks to your ability to adapt! Managing stress effectively, facing adversity with serenity and adjusting quickly to new environments are skills that coaching helps you hone and master. These tools build resilience (adapting to organizational change), enabling you to maintain your performance even in uncertain or difficult situations – an invaluable asset for professionals often called upon to intervene in crisis situations. Crédit photo : Laurent Besnehard, Le 7e studio BOOSTING SELF-CONFIDENCE The coaching process encourages introspection and continuous personal development. Team and company leaders benefit from a better understanding of their strengths and a clear identification of areas for improvement. This deeper self-knowledge boosts their confidence in their leadership abilities. For Sarah, this newly-acquired self-confidence translates into greater ease in making bold decisions and defending her ideas in front of a variety of interlocutors, a crucial element in successfully carrying out her mission. INCREASED ABILITY TO CHANGE TRANSITIONS The experience of coaching during periods of intense change enables decision-makers to develop a unique expertise in change management. They learn to anticipate and manage resistance, effectively communicate a vision of transformation, and mobilize the resources needed to bring complex transitions to a successful conclusion. This skill obviously becomes an asset throughout their careers, positioning them as strategic leaders for organizations seeking to evolve. LUGAN CONSULTING : MANAGERS COACHING I’ve been coaching managers and executives as a certified independent coach for over 7 years. My approach is largely based on a philosophy of well-being at work. Contact IMPROVING STRATEGIC VISION Coached managers and executives also learn to refine their strategic thinking. They acquire the ability to step back from complex situations, identify long-term trends and anticipate future challenges. This tactical vision enables them not only to be proactive, but also to positively influence the direction taken by their organization. DEVELOPING A CONTINUOUS LEARNING MENTALITY Executive coaching instills a culture of continuous learning. People who have benefited from it develop the habit of actively seeking feedback, reflecting on their experiences and constantly adjusting their approach. This openness to continuous learning becomes a powerful driving force for their professional development throughout their career. IMPACT ON WORK/LIFE BALANCE Once the coaching process has been successfully completed, the positive repercussions also influence the coachees’ personal lives. They acquire : Greater self-awareness A deeper understanding of their values and motivations Tools for effective time and energy management These personal benefits translate into improved professional performance and a more fulfilling career in the long term. EXPANDING YOUR PROFESSIONAL NETWORK The coaching experience often exposes them to new perspectives and leadership practices. This may lead them to participate in communities of practice, attend specialized conferences or join think tanks… These connections enrich their professional network, offering opportunities for collaboration and exchange of ideas throughout their career. I see on a daily basis that the long-term impact of management coaching is profound and multidimensional. From improving leadership skills to sharpening strategic vision and personal development, it leaves a lasting imprint that shapes not only careers, but the overall approach to leadership. These benefits make coaching a valuable investment both for the managers themselves and for the organizations that benefit from their skills for years after their initial assignment has ended. In an ever-changing business world, coaching is emerging as an easily activated tool for developing agile, resilient and visionary leaders capable of guiding their organizations towards sustainable success. Frank LUGAN COACH FOR MANAGERS & CEO Posts récents THE LONG-TERM IMPACT OF COACHING ON MANAGERS AND EXECUTIVES Pharmaceutical industry training: optimize your quality strategy Getting to know each other better to work together more effectively GMP: ANSM publishes the French translation of Annex 1. How can you adapt your action plans? Well-being at work: pharmaceutical industry managers as a remedy for employees? Decarbonization of pharmaceutical companies: how to get started? Data Integrity : 8 steps to becoming compliant Pharmaceutical audit Team building : secret of success ANSM injunction : how to react ?

Pharmaceutical industry training: optimize your quality strategy In 2025, it will be impossible not to make training in the pharmaceutical industry an essential component of pharmaceutical company strategy. French reindustrialization, increasing global competition, changing standards, waves of recruitment and production rates are all factors demanding operational excellence. In this fluctuating context, team training consolidates the pillars of pharmaceutical production: innovation and quality. As an expert in supporting executives, managers and operational staff in pharmaceutical manufacturing, I present in this article the 5 points that make training the key to your performance. 5 arguments in favor of training pharmaceutical production teams Training must be seen as the cornerstone of quality, because by implementing it, a pharmaceutical company will be able to : 1-Improve regulatory compliance The ever-changing nature of regulations (GMP, ICH, revision of EU pharmaceutical legislation, etc.) keeps pace with the adjustments that drug manufacturers have to make. In recent years, for example, regulatory changes have responded to a number of constraints: The decarbonization and ecological transition of the pharmaceutical industry (multilingual packaging, e-notice, etc.); The health scandals of recent years have led to a tightening of regulations, which is changing industrial practices, the vigilance of health authorities and awareness of public health issues. The fight against shortages (Shortage Management Plan [ PGP ], reporting obligations, notification of shortage risks or supply disruptions, constitution of safety stocks, etc.). Training guarantees the harmonization of legislative knowledge among teams at all levels of drug production, and removes the burden of financial penalties resulting from ANSM injunctions. 2-Maintain the quality and safety of pharmaceutical and cosmetic products Staff training is an integral part of the quality process, as it is an essential lever in the error prevention process. Mastery of ICH guidelines (ICH Q9 and ICH Q10) prevents incidents with serious consequences for product quality and safety. Reducing human error : ongoing, job-specific training provides a better understanding of processes and limits errors linked to misinterpretation. This approach helps to reinforce vigilance, encourages feedback, and enables potential deviations to be quickly identified and corrective action taken. 3-Drive innovation and development At a time when the French government is mentioning healthcare and biotechnology as a sector with a promising future in terms of jobs by 2030, Leem’s article, La place de la France dans la production de médicaments, questions France’s current sovereignty in the field of biotechnological innovations. According to the organization, “it is essential to diversify production by integrating more innovative drugs and adopting new technologies”. This strategy implies, as of today, a rethinking of the innovations themselves, as well as work on the teams required to cope with the changes. Adapting to new technologies : innovation is often made possible by introducing new or novel technologies into the manufacturing process. Training enables employees to acquire the skills needed to use new technologies and production tools. Continuous improvement : by encouraging continuous training, companies foster a culture of continuous improvement and innovation. Recruiting digital profiles: the digital transition is accelerating the need for staff with strong digital skills. The search for “IT” technical profiles (specialized in Data Integrity) sometimes means having to integrate candidates from outside the pharmaceutical sector. Targeted training helps these employees to assimilate issues such as pharmaceutical quality and GMP, and ensures their successful integration. 4-Reduce production risks Quality risk management (ICH Q9) represents an entire chapter of GMP. A standardized methodology is required to Prevent incidents : by implementing preventive measures. Manage crises : once trained, managers and operational staff know how to react effectively in the event of an incident. 5-Engaging and caring for teams Training is also an important criterion in CSR policies. Its implementation promotes well-being in the workplace by acting on : Personal development: training is an important motivating factor for employees. It enables them to develop personally and professionally, and to acquire new skills. Loyalty : satisfied, trained employees are more likely to stay with the company. Strengthening team cohesion In-company training: summary of benefits * Quality improvement: guaranteeing compliance with standards and reducing risks. * Increase productivity: optimize work processes and methods. * Skills development: promote employee fulfillment. * Brand image enhancement: position the company as a serious and competent player. Contact Us Lugan Consulting Pharmaceutical Quality System training courses Our training catalog covers all aspects of the pharmaceutical quality system: GMP, quality management, data integrity, risk analysis, qualification and validation, etc. Take advantage of LUGAN CONSULTING’s expertise, thanks to entertaining curricula tailored to your day-to-day professional life. Each of our 10 themes addresses a specific issue and aims to achieve several objectives: GOOD MANUFACTURING PRACTICES How to ensure compliance of operations in a GMP environment? Know how to apply GMP rules within the company. Understand who is responsible for implementing GMP requirements. Identify the risks applicable to your department’s activities. DATA INTEGRITY IN THE PHARMACEUTICAL INDUSTRY How to guaranteedata integrity in a GMP environment? Know and understand regulatory requirements for data integrity Understand the main concepts associated with data integrity (ALCOA) Be able to take stock of the current system RISK ANALYSIS IN THE PHARMACEUTICAL INDUSTRY How to successfully implement an ICH Q9 risk analysis approach Promote and deploy the risk analysis approach within the company Understand and apply the regulatory requirements for ICH Q9 risk management. Select and implement the various risk analysis tools appropriately Lead a risk analysis session HUMAN ERROR IN DRUG PRODUCTION How to analyze and prevent the risk of human error in a GMP environment? Identify the different types of human error Identify and understand risk factors Analyze the causes of human error Optimize processes, systems, procedures and organization to reduce errors QUALIFICATION AND VALIDATION IN THE PHARMACEUTICAL INDUSTRY How to guarantee the conformity of operations in a GMP environment? Understand the general principles of GMP qualification and validation Understand and apply qualification and validation requirements in the pharmaceutical industry Define a qualification and validation strategy for your business sector To obtain details of LUGAN CONSULTING training sessions, download our catalog :   INTERNAL AUDIT Audit

Getting to know each other better to work together more effectively How do you harmonize team spirit? Communication problems are rife in every company. It’s only human. Teams are often made up of a variety of profiles, each with their own specific skills, but these differences can sometimes be a source of tension. Balance within teams has an impact on the working atmosphere and, by extension, on the company’s performance! I’m regularly asked to help strengthen team cohesion, and I teach the members of my teams to get to know each other better so that they can work together more effectively. The case study below describes how I help all the individualities to come into harmony so that they can play the company’s symphony from the heart. My preferred instrument? Process Com®. A case study: the HR team of a pharmaceutical company Last spring, I was contacted by the HR manager of a pharmaceutical production company in the west of France, who was faced with a delicate situation: the departure of a long-standing assistant had weakened the team and created tensions. The team, made up of very different profiles, was finding it difficult to find a common rhythm. A polarized team The profiles of the employees involved made delegation less straightforward than it had been until then: A young assistant who suddenly found herself propelled to the position of team referent and assistant-principal, despite her short experience. A payroll manager whose organization, characterized by autonomy and great rigor, can sometimes seem rather uncooperative. A young nurse, recently hired, pleasant, but discreet and still in the background due to her recent arrival in the company. A work-study student, whose presence is divided between his studies and his professional assignments. A vigilant manager The manager, aware of the dissimilarity of his colleagues, was looking for a solution to optimize the functioning of the group. Given the need to bring harmony to the group and consolidate the bonds between its members, he contacted me to set up a team-building program. Team-building phases It’s rare for a team to reach cruising speed spontaneously. According to Tuckman, an American psychologist, team building goes through 4 phases before finding a form of harmony: Each of these stages requires specific support from the manager. Moreover, each change in the team restarts the cycle from the beginning. This was the case for my customer, following the recent reshuffle that had taken place. A team-building seminar to reconnect After taking stock of the situation, I suggested to the HR manager that we work on team cohesion along 4 lines: Defining the profiles of the various team members; Reminding everyone of their roles and responsibilities; Define the department’s vision/mission and draw up a roadmap; Identification of a service project (unifying event). Planned as a 3-day seminar, this session brought together 5 participants, including the manager. It was organized off-site, and included outdoor activities, workshops and interaction. The program was designed to convey the 4 principles of the Process Com® (or PCM®) philosophy: Get to know yourself ; Learning to recognize sources of stress and manage emotions; Learning to recognize others; Learn the communication tools needed to interact in a relationship and adapt to the other person. Getting to know yourself better: a preliminary personality test Process Com profiles A few days before the seminar, participants are invited to take part in an online personality test. It enables individuals to identify themselves under one of the 6 profiles defined by Process Com and thus : Understand what structures their personality; Get an idea of their strengths; Understand how they function under stress. Each of the 6 personalities defined by the method is associated with a color, characteristics and behaviors under stress. For each profile, correspond : Strengths ; Modes of perception ; Elements of language and expression; A preferred communication channel; Psychological needs; Interaction styles; Behaviors under stress. A PCM® test measures the content of these 6 profiles in your personality and highlights the dominant type to which you belong. For, in reality, we are the sum of our different personality types. An inventory of individualities… that make up a colourful team The PCM® model underlines the importance of a diversity of profiles within a team. Indeed, a dominant color can create bias and limit creativity or, conversely, deprive it of rigor. The opening day of the seminar is devoted almost entirely to personality work. The aim is to map out the team and identify the sources of tension (often due to misaligned communication channels). By getting to know ourselves and each other, we can clarify the channels of discussion and enable everyone to find the right frequency of communication with their colleagues. Case studies and exercises After the discovery phase, I involve participants in more dynamic interactions. The presentations combine workshops, exercises and role-playing. I alternate introspective episodes, exchanges and feedback. In my experience, this is systematically beneficial. Let’s take a look at the 3 exercises carried out during this case study workshop. (Yes, they vary according to the situation, as LUGAN CONSULTING’s services are tailor-made). Post it workshop To promote cohesion, I asked team members to express their views on the group’s strengths and weaknesses. This exercise revealed very different perceptions within the team, highlighting misunderstandings and differences of opinion. It turned out that a lack of communication was at the root of some of the tensions. Regards Croisés (Team Dating) This exercise takes the form of “Team Dating”: participants engage in individual interviews to give and receive constructive feedback. This method, inspired by speed dating, creates a safe space to express thoughts and feelings in an honest way. I’m wonderful Avec cet exercice, les participants sont invités à finaliser leur autodiagnostic. Je demande au groupe d’essayer d’identifier le profil de ses collègues. Après un temps de réflexion, à tour de rôle, les stagiaires sont invités à faire un retour collectif sur une personne. La personne annonce également le profil qu’elle pense avoir.  Test results The results of

GMP: ANSM publishes the French translation of Annex 1. How can you adapt your action plans? On 15 July, ANSM notified the publication online of the French translation of Annex 1 of the Good Manufacturing Practices (GMP) for medicinal products for human use. The European Commission had initially re-examined this chapter, dedicated to the specificities of the production of aseptic medicinal products, in order to standardise manufacturing practices on an international scale. Since its publication on EudraLex in August 2022, manufacturers have been complying with this original version, which has been in force since August 2023. The transposition of the revised Annex 1 of the European Good Manufacturing Process (GMP) is intended to remove any ambiguities about the enforceability of the text, since it effectively brings it into line with French law. For French manufacturers, this translated version should also clarify ambiguous wording and points in the original text. What impact will the revision of Annex 1 have on companies? How can it be implemented on production sites? What are the challenges of GMP compliance? Lugan Consulting has the answers. GMP: revision of Annex 1 on the manufacture of sterile medicinal products Appendix 1 lists the fundamental principles for the manufacture of sterile medicinal products. It was originally published in 1971 with the aim of providing an exhaustive manufacturing guide. It has already undergone several revisions. The most recent revision, in 2022, was initiated to take account of the impact of the Covid crisis, regulatory changes and the increasing use of new technologies for the manufacture of sterile medicinal products. A further update was needed to incorporate manufacturing strategies based on new technologies, to specify sterilisation methods and to take account of rapid analysis techniques. The new edition therefore includes 11 new sections, as well as a glossary for greater clarity. Scope of GMP Annex 1 ‘Sterile’ refers to medicines that are “uncontaminated by micro-organisms” (microbes, particles, bacteria, fungi, viruses, etc.). The absence of these elements is essential to guarantee the safety and efficacy of aseptic preparations, as their contamination could lead to serious or even fatal infections in patients. When we talk about the manufacture of sterile products, we are talking about products, different presentations, processes and technologies. These include Terminal sterilised medicinal products (ampoules and vials for injection, intravenous solutions, sterile eye drops and ointments, etc.) Medicinal products prepared in controlled atmosphere areas (vaccines, blood-derived medicinal products, medicinal products administered by intravenous or intrathecal injection, ophthalmic medicinal products, sterile topical medicinal products, etc.). Changes brought about by the update of GMP Annex 1 The introduction of the new Annex 1 has led to some major changes. The directives focus on preventing contamination, without minimising the detection or removal stages. The changes relate to 4 areas: Taking technology into account One of the recommendations (section 2.1) highlights the appropriate use of technology in aseptic production operations: restricted access barrier systems (RABS), isolators, single-use technologies, robotic systems, rapid or alternative methods, continuous monitoring systems, etc., in order to be able to rapidly detect any contamination of the environment or the product during the manufacturing process. For manufacturers, the introduction of technology can also be a solution to improve the reliability of operations or save time, such as the automation of candling, for example. However, the introduction of technology is the first step towards the future of aseptic manufacturing, with human presence reduced to a minimum (use of isotechnology). It is clear that the risks of contamination inherent in the latter can be reduced by introducing robotics, or even Artificial Intelligence. The big names, such as Sanofi, have already done this. However, the emphasis is on the fact that these technologies and automated monitoring systems need to be operated by staff who are trained and qualified to use them. In all cases, the use of the technologies must be documented in the CCS, another new feature of the update. Contamination Control Strategy (CCS) This is one of the major changes to be taken into account in this new version. CCS is a systematic, documented approach implemented as part of a policy to ensure and prevent the risks of contamination in the manufacture of sterile medicinal products. In practice, establishing this strategy involves drawing up technical and organisational documentation defining the means of control. It is then used as a reference for risk assessment. The key elements of an effective CCS are : Risk assessment: Identify potential sources of contamination in all aspects of manufacturing, including raw materials, equipment, personnel and production environments. Control measures: implement appropriate protocols to eliminate or minimise identified risks, such as disinfection, sterilisation and environmental monitoring. Monitoring: regularly observing the effectiveness of control measures and the presence of contaminants in environments and products. Review and update: regularly review and update the CCS to take account of changes in manufacturing processes, risks and scientific knowledge. The update recommends the implementation of a SCC, while stressing that manufacturers of sterile medicinal products must adapt it to their specific facilities and products. The SCC must be documented and applied by qualified personnel. They must have sufficient knowledge of sterilisation and microbiology at all levels of the organisation. Compliance with the CCS is now one of the inspection points monitored by the regulatory authorities. Quality Risk Management (QRM) Update 2024 does not introduce any new QRM requirements, but aims to achieve international harmonisation of processes, operations and limits. It therefore covers a wide range of subjects: the layout of cleanrooms, equipment and manufacturing methods, staff training, choice of clothing, cleaning and disinfection procedures, qualifications and monitoring systems, etc. Evidence of the implementation of risk management is characterised by : Appropriate design of plant, equipment and manufacturing processes. The creation of procedures adapted to the manufacturing activity specific to the type of product being manufactured. Setting up a monitoring system. QRM becomes a systematic and proactive approach, to be carried out throughout the sterile medicinal product manufacturing process (this is a link between the manufacture of sterile medicinal products and the

WELL-BEING AT WORK: PHARMACEUTICAL INDUSTRY MANAGERS AS REMEDIES FOR EMPLOYEE ILLS Every year, Quality of Life at Work (QWL) week is a reminder that employees well-being is not a luxury, but an investment. Far from being a simple philanthropic issue, QWL is a proven competitive lever: more attractive companies, more committed employees, higher productivity. These arguments are leading to a proliferation of QWL initiatives, but the philosophy remains difficult to establish in the long term. This is particularly true of pharmaceutical manufacturers, who are facing specific challenges. The major changes currently taking place in the sector provide a relevant case study. The upheavals (relocation, restructuring, mergers and acquisitions, massive recruitment, etc.) mean that sustaining a QWL culture is no longer an option, but a necessity to ensure the success of the transformations. Against this backdrop of change, how can drug manufacturers safeguard the mental health of their teams and promote the fulfilment of their managers, who are the guarantors of performance? MANAGING TEAMS WITH CARE He is one of the company’s figureheads, the bearer of its colours and values. They are the ones who pass on the directives and practices endorsed by the entire management team. They ensure that these are applied in order to meet performance targets. The stakes involved in this pivotal role are often a source of pressure, fuelling stress that can have an impact on employees. Because of the manager’s position in the hierarchy, his active involvement in the decision-making process and his role as a transmitter of information, he is (increasingly!) seen as being responsible for the mental health of the people he supervises. In fact, studies into well-being at work regularly highlight employee/manager relations as the source of ill-being in the workplace. For example, the Malakoff Humanis “Absenteeism 2023” barometer shows rising figures: 50% of employees have been off work at least once during the year, the highest level since 2016. The proportion of long stoppages (more than 30 days) due to psychological problems has more than doubled (31% of companies are affected by this phenomenon). The study also shows that employees who have taken time off work for psychological reasons in the last 12 months blame their work environment and managerial practices. The reindustrialisation currently taking place in the region is having its share of repercussions for players in the sector. In this context, how can managers achieve their objectives while respecting the delicate balance between the company’s policy and the meaning that employees wish to give to their work, and above all while preserving their health? Lugan Consulting : coaching for managers – Crédit Photo : Laurent Besnehard – Le 7eme Studio The role of the manager in promoting well-being at work during a period of transition Above all, managers must approach their mission with sincerity. Authentic leadership is recognised as a lever for well-being. The QWL approach is therefore an incentive to remain oneself in one’s duties and to be in line with one’s values and deepest convictions (principle of coherence). Self-awareness (knowing one’s strengths, weaknesses, values, motivations, etc.) helps to ensure this posture. It naturally leads to an open and honest management style, based on trust and mutual respect. Authentic leaders delegate tasks and encourage autonomy. They are as focused on results as they are on the well-being of their employees. In addition to this approach, they can work with their teams in 4 different roles: The role of leader is one in which the manager is a team leader who stimulates autonomy and initiative-taking. Finally, as provided for in the collective agreement on well-being at work (2020), they must recognise and value their work. The role of organisational support consists, in practice, of maintaining a close operational relationship, but also of developing and supporting employees through individual and group coaching, training, the allocation of resources or the creation of ergonomic and pleasant workstations. He is a great believer in teamwork and cohesion. The role of emotional support. According to a 2023 Forrester study for Indeed, a manager’s empathy plays a major role in the well-being of employees, who mainly expect him or her to listen (62%) and provide support (49%) in difficult situations. Career development is also one of the issues they want to discuss (25%). To respond to these situations, the manager can rely on a compassionate stance, as well as active listening and openness to dialogue. They need to be able to help employees adapt to change. In practical terms, this means, for example, encouraging them to express their feelings. As a communicator, you need to be able to engage in a friendly exchange, based on active listening, and to pass on clear, transparent information, with no double-talk. Of course, this also means showing respect and confidence in their teams. This palette can be used as a tool to stimulate the 4 key objectives of QWL: Encouraging employee autonomy and empowerment; Develop clear and transparent communication; Encouraging trust, collaboration and teamwork; Implement stress and RPS prevention measures. Adapting your management style to the realities of the pharmaceutical sector The pharmaceutical sector presents unique challenges and opportunities for managing quality of life at work (QWL). To adapt to these realities, managers need to adopt an appropriate posture, taking into account the particularities of the field. Strict regulatory requirements: managers need to provide additional support (operational, organisational and emotional), foster open communication and create a climate of trust to help employees navigate a complex, legislated environment. Complex manufacturing processes: clear training, adequate resources and tools, and an environment where employees feel comfortable reporting problems and asking for help, are essential to ensure accuracy and quality. Operator safety: rigorous safety programmes, appropriate training and a safety culture where employees feel comfortable reporting hazards and asking for help are essential to protect workers. Teamwork and collaboration: fostering a cooperative environment where employees feel comfortable sharing ideas and working together. Effective communication and coordination between different teams is crucial to achieving common goals. Work-life balance: promoting practices such as teleworking, flexible

Decarbonization of pharmaceutical companies: how to get started? Whether you are a pharmaceutical manufacturer or a contract manufacturer, you should be aware that in October 2023, Leem introduced the signing of a collective industry pact. The consensus, entitled ‘Leem’s Decarbonisation Plan’, aims to bring the pharmaceutical industry into line with the objectives of the 2016 Paris Agreements. A study carried out by the union in 2022 estimates that the sector is responsible for 4.4% of global greenhouse gases (GHGs). French drug production alone generates a carbon footprint of 11.8 MtCO2e. In April 2023, the roadmap for the pharmaceutical industry, published by the Conseil National de l’Industrie (CNI), stated that 60% of companies in the sector had not yet undertaken a carbon footprint assessment. While there may be obstacles, there are many benefits to be gained from making the transition. Here’s an overview. The issues and challenges involved in decarbonizing industry The IPCC’s alarmist reports are calling on nations to significantly accelerate the ecological transition processes already underway in their territories. By 2022, France has committed itself to a goal of decarbonising its industry. This ‘carbon neutral’ strategy targets 4 categories of challenges: Abandoning carbon, an environmental challenge Clearly, it is first and foremost the collective interest that is at stake. Reducing greenhouse gases (GHGs) is an altruistic act that marks a commitment to public health and the fight against the harmful effects of global warming. The energy transition, a regulatory challenge Faced with an accelerating climate emergency and the condemnation of the ECHR for inaction, public authorities at national and European level are setting their objectives within an increasingly strict legislative framework. Their commitment is set out in several founding texts. These include The Paris Agreement (2015) ; The Européan Alliance for Green Industry (2019) ; The AGEC act (2020) ; Climate and Résilience Act (2021) ; The National Decarbonisation Pact for french industry(2022). 💡 On 9 April 2024, the ECHR (European Court of Human Rights), in condemning Switzerland for its climate inaction, recognised the right of individuals to be protected by the State, against the harmful effects of climate change.al de Décarbonation de l’Industrie Française (2022). In France, for example, these requirements take the form of the CSRD directive (Corporate Sustainability Reporting Directive), which came into force on 1 January 2024. The directive requires large institutions (those with more than 500 employees and sales of €50 million and profits of €43 million for two consecutive years) to carry out an energy audit, which they must declare on ADEME’s Bilan GES portal, on pain of a fine of up to €50,000. A timetable sets out the 3 stages of implementation for each type of company. To date, the regulations are due to come into force for listed SMEs in 2026. It is easy to imagine that a change in the law will require all forms of company to comply by 2030.   Reducing emissions: an economic opportunity The saying is well known (and particularly relevant to the pharma sector): ‘Prevention is better than cure’. It also takes on its full meaning in the context of the ecological transition, where failure to anticipate has a negative impact. The costs of inaction on climate change are already measurable, and the figures that abound in reports point to clear trends: increase in the cost of insurance ; a multiplication of the cost of the additional resources needed to adapt to unforeseen disruptions; a growing impact on GDP. While the financing required for the decarbonisation process sometimes hinders the transition to action, it has a real return on investment. In the long term, inaction has a more severe impact on the company’s economy. The holistic approach of the ONE HEALT concept recognises the inextricable correlation between human, animal and environmental health. It highlights the cyclical effects of dependence on fossil fuels: the contamination of biotopes causes animal diseases which lead to human pathologies. This representation demonstrates the paradox of the pharmaceutical system, which, by polluting, not only increases what it exists to do, but also creates its own obstacles: the increase in extreme weather events, particularly in countries supplying raw materials (Asia, India, etc.) is one of the factors in the supply shortages affecting Europe. The damage caused to crops and production facilities, as well as the higher costs incurred in manufacturing and exporting, have repercussions at every stage of the drug supply chain. The ecological transition: a measure to ‘stay in the race’ Planning measures in favour of decarbonisation encourages approaches with a systemic effect: for example, one of the ideas put forward is to call on subcontractors who are themselves involved in a 0-carbon strategy. Over and above the moral commitment, decarbonising your business will prove essential to maintaining your competitiveness: not being decarbonised automatically risks taking you out of the loop, on the grounds that you are not contributing to green synergy. As well as raising the profile of the company, France sees decarbonisation as an argument for attractiveness. The government’s 0-carbon ambitions are combined with the ‘Choose France’ policy: being a pioneer in decarbonised industry and having, by 2025, eco-responsible industrial zones, a decarbonised mix and excellence in decarbonisation technologies should encourage foreign firms to set up here. Decarbonization strategies of pharmaceutical manufacturers In a 2022 study, the Observatoire des Compétences Industries identifies 4 major sources of the pharmaceutical industry’s impact on the environment: the environmental footprint of packaging; the environmental footprint of logistics; the post-use management of products; the environmental impact of manufacturing, in relation to products quality and safety standards. The study also shows that responding to these issues is complicated by : the regulatory framework; the absence of technical or technological solutions; the complexity of value chains and of sourcing products locally (the fact that some French subsidiaries are part of a foreign group limits local R&D). The Leem industry agreement sets out 3 levers for action (the trajectories are calculated on the basis of companies that have not yet initiated their transition): decarbonisation of energy supply; decarbonising

DATA INTEGRITY: 8 STEPS TO COMPLIANCE The pharmaceutical industry has to ensure a constant quest for quality in an ever-changing regulatory environment. To achieve this, the generation of electronic data has become an inevitable solution, and one that has been implemented in many organisations. Data servers, clouds… the practicality and time-saving benefits of digital technology are major advantages that promote functional quality systems. But like all developments, there is a corollary that must not be overlooked: data integrity. This has become a major security issue for pharmaceutical organisations. Find out below about the different phases you need to consider in order to achieve compliance and take the first steps in your data management policy. 1- KNOWING REGULATION Data integrity in the pharmaceutical industry is closely linked to Good Manufacturing Practice (GMP) and the GxP environment, encompassing Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Distribution Practice (GDP). These standards govern the processes and systems used in the production and distribution of medicines, guaranteeing their quality and safety. In France, compliance with these standards is mandatory under the Public Health Code, in particular articles L. 5111-1 and R. 5121-114, on pain of severe penalties and repercussions for the company’s reputation. As a reminder, you will find below a summary of the regulatory texts on data integrity in the pharmaceutical industry: Data Integrity and Compliance With Drug CGMP : Questions and Answers- Guidance for Industry MHRA’s ‘GXP’ Data Integrity Guidance and Definitions OECD’s Advisory Document of the Working Party on Good Laboratory Practice on GLP Data Integrity PIC/S’s Guide “Good practices for data management and  integrity in regulated GMP/GDP environments” Guide de bonnes pratiques de gestion des données et des enregistrements Annexe 11 des BPF : Guide des BPF pour les systèmes informatisés     What are the implications of non-compliance in terms of data integrity? Failure to comply with the regulatory texts on data integrity in the pharmaceutical industry obviously entails its share of sanctions: warnings, injunctions, withdrawal of marketing authorisations and criminal proceedings. It also has collateral consequences that I leave to you to assess: risks to public health ; economic repercussions damage to the company’s reputation. 2- MANAGING A PROJECT TEAM Compliance requires a collaborative approach, involving various stakeholders such as quality, IT and possibly legal teams. A project manager with data-integrity expertise is essential to structure the efforts and guarantee the effectiveness of the actions undertaken. A typical team dedicated to data integrity could be made up as follows: Quality manager: This professional is responsible for overseeing the entire compliance process and ensuring that standards and regulations are respected. He or she is the guarantor of data quality and works closely with other team members to coordinate actions and initiatives. IT Manager: responsible for selecting, implementing and maintaining the IT systems needed to manage and protect data. They must ensure that these systems comply with security and confidentiality standards. Regulatory expert: This professional has in-depth knowledge of the legislation in force in the pharmaceutical industry. They advise the team on regulatory requirements and ensure that all actions taken comply with these standards. Training Manager: Staff awareness and training are essential for the successful implementation of new processes and systems. The Training Manager is responsible for designing and delivering programmes tailored to each level of the organisation. Operational team members: In addition to the key players mentioned above, the project team may also include staff from different departments within the company, such as production, clinical procedures, research and development, etc. Their sector expertise and knowledge of the new processes and systems is essential for the success of the project. Their sector expertise and knowledge of specific business processes are invaluable in identifying the data integrity needs and challenges in their respective areas of activity. 3- UNDERSTANDING DATA FLOW An in-depth understanding of the flow of data is needed to identify points of vulnerability and implement appropriate controls. The dematerialisation of documents can facilitate this understanding by making data more accessible and more easily traceable, but it is important to know how it is organised and classified. The first steps to be taken are therefore to : Mapping data flows throughout the organisation to understand how data is generated, stored, transferred and used. Identifying critical points in the data flow where additional control measures may be required to ensure data integrity. Steps to compliance of data integrity 4- KNOW YOUR SYSTEMS La sécurité des données est un aspect critique de la gestion de l’intégrité des données. Cela comprend à la fois la sécurité physique des infrastructures et des supports de stockage, ainsi que la sécurité logique pour contrôler l’accès aux systèmes et aux données. Les mesures de sécurité doivent être robustes pour prévenir toute altération ou accès non autorisé aux données, et des plans de continuité d’activité doivent être établis pour garantir la disponibilité des données en cas d’incidents ou de sinistres. Votre plan doit ainsi prévoir d’effectuer un inventaire des systèmes informatiques et des processus associés. Il conviendra de s’assurer qu’ils sont conformes aux normes de qualité et de sécurité. Ensuite, il faudra identifier les lacunes potentielles dans les systèmes et proposer des solutions pour les corriger et améliorer l’intégrité des données. YOUR DATA INTEGRITY POLICY MADE SIMPLE LUGAN CONSULTING has established expertise in the field of Data Integrity. By delegating this task to us, you can ensure that your data is compliant with regulatory requirements. Contact us 5- ANALYSING CRITICALITY Some data is more critical than others and deserves special attention in terms of protection. An in-depth analysis of the criticality of data enables you to prioritise actions and concentrate efforts where they are most needed. For example, you could start by assessing the criticality of data in terms of its impact on the quality of pharmaceutical products and on patient safety. Then prioritise data governance efforts by focusing on the data that is most critical to the business. 6- EVALUATING SYSTEMS A systems audit is based on a number of principles, including the ALCOA +

INTERNAL AUDIT IN THE PHARMACEUTICAL INDUSTRY The pharmaceutical industry is faced with numerous risks related to non-compliance, product quality and inefficient process management. The consequences of these risks represent a real sword of Damocles for the managers of pharmaceutical manufacturing units. The constraints represented by the precautions to be taken to guard against them are omnipresent. As legislation evolves, manufacturers in the sector are under constant pressure to guarantee the safety and efficacy of their goods whilecomplying with the strict standards imposed by the regulatory authorities. Internal audit is a reliable tool in the fight against these risks. It enables a thorough assessment of processes, control systems and operational practices within pharmaceutical companies to avoid the damaging consequences of regulatory non-compliance, such as fines, product recalls or loss of reputation. ASSESSMENT POINTS TAKEN INTO ACCOUNT By identifying gaps and areas of non-compliance, the audit provides a valuable opportunity to initiate proactive corrective action. With this in mind, several aspects are closely examined: Production operations, including the weighing, manufacturing and packaging stages, are scrutinised to ensure their reliability. Stock management and distribution are assessed to maintain the integrity of products throughout their journey. Quality control, including physico-chemical and microbiological analyses, is scrutinised to ensure compliance with established standards. Technical aspects such as maintenance, purified water production systems and other utilities are also examined to ensure that they are working properly. PHARMACEUTICAL SECTOR AUDIT: SPECIFIC CONTROL POINTS In order to cover the specific aspects of the pharmaceutical quality system, the audits also cover : Pharmaceutical documentation (batch records, procedures, operating methods). Management of deviations and CAPA. The change management system (Change Control). Supplier quality system (approval, certification). Data integrity. Staff training. Maintenance (preventive, calibration and calibration). BENEFITS OF INTERNAL AUDIT Regulatory Compliance The internal audit ensures that the company’s activities comply with current standards and regulations, thereby reducing the risk of non-compliance. It also avoids the risk of receiving an ANSM injunction. Continuous improvement By identifying shortcomings and proposing recommendations, internal audit helps to improve internal processes and enhance operational efficiency. Risk Management By assessing potential risks and implementing preventive measures, internal audit helps to anticipate and manage the risks associated with pharmaceutical activities. By integrating an internal audit programme, you can ensure quality, compliance and overall performance throughout the organisation. By implementing regular controls, you can identify opportunities for improvement, build stakeholder confidence and ensure the sustainability of your business in a highly regulated environment. Investing in dedicated internal control resources, training your staff in best practice and implementing a continuous improvement process will position you as a reliable player in the pharmaceutical sector. GET AN OUTSIDE VIEW OF YOUR ACTIVITIES How do you rate your level of compliance? Are you confident about your next regulatory inspections? Contact LUGAN CONSULTING for a more detailed discussion of your needs and your sector. (contact@luganconsulting.com) Contact us Frank LUGAN PHARMACEUTICAL QUALITY EXPERT Latest posts Data Integrity : 8 steps to becoming compliant Pharmaceutical audit Team building : secret of success ANSM injunction : how to react ? The drug manufacturing process : from research to market launch