Category: Uk

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

Team cohesion: the secret of success In today’s business world, a company’s success depends to a large extent on the ability of its teams to work together harmoniously and effectively. Team cohesion is essential to achieving objectives and stimulating innovation. Yet building and maintaining this unity is not always an easy task. In this article, we explore the key elements that promotecollective understanding, highlighting the importance of roles and responsibilities, the different phases of team building, and the imperative of having a clear vision and mission. Building a Team by Following the Steps To build a solid, high-performance team, it is important to understand the different stages in a group’s development. Bruce Wayne Tuckman, American psychologist and father of team-building , formalised the eponymous diagram which describes the four key stages through which teams pass: Step 1 : Forming At the beginning, team members get to know each other and try to understand their respective roles. This is a phase where expectations are often unclear, and where it is important for the leader to guide and clarify objectives and processes. Step 2 : Storming As members begin to work together, conflicts and differences of opinion may arise, particularly about how to achieve objectives. This is a necessary stage where members learn to negotiate and resolve conflicts constructively. Step 3 : Norming Once the initial tensions have been overcome, the team begins to find its rhythm and establish common working standards. Communication improves and members learn to collaborate effectively. This is a stage where the team begins to structure itself, with rules standardised through a common working framework. Step 4 : Performing In this final phase, the team is working to its full potential. The members are autonomous, motivated and work together coherently to achieve the objectives set. Cooperation is efficient. Tuckman’s principle (Click for zooming) DEFINE THE VISION AND MISSION A clear vision and mission are the glue that keeps a team together and motivated. The vision defines the team’s long-term goal, while the mission sets out its immediate purpose and core values. When all team members share and believe in this vision and mission, they are more likely to work together harmoniously and overcome obstacles with determination. GETTING TO KNOW EACH OTHER BETTER TO WORK BETTER TOGETHER This training course from our catalogue is dedicated to strengthening team cohesion by working on communication. Contact us Unite the group by clarifying roles and responsibilities ​ Each team member brings unique expertise and specific skills. You will optimise the group’s performance by clearly defining each person’s roles and responsibilities. This strategy not only avoids overlap and conflict, but also ensures that each individual’s potential is fully exploited. By assigning clear missions, team members understand what is expected of them and can concentrate on accomplishing their specific tasks. The result is a feeling of trust and mutual respect between employees, because everyone knows that they can count on the others to fulfil their commitments. The Belbin model (Dr Meredith Belbin) establishes an inventory of roles according to 3 categories: Thinking roles (Designer, Taker, Expert) Action roles (Organiser, Promoter, Perfecter) Relationship roles (Coordinator, Supporter, Promoter) Each individual has a specific role within the team. By identifying and defining each person’s role, you can better understand your strengths and work together more effectively. Belbin’s model Team cohesion is an essential element of organisational success. By clearly defining roles and responsibilities, successfully navigating the Tuckman model of team building, and cultivating a shared vision and mission, teams can not only achieve their goals, but also thrive and innovate in a collaborative and motivating work environment. TEAM-BUILDING WORKSHOPS IN YOUR OFFICES! LUGAN CONSULTING can come to your company and organise fun, interactive team-building workshops. Book a session now. Contact us Frank LUGAN PHARMACEUTICAL QUALITY EXPERT Last 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

ANSM injunction: how to react? In France, ANSM (Agence Nationale de Sécurité du Médicament)  is the authority responsible for protecting public health. If a any risk would threats this one, the potential harm caused by a failure in the drug manufacturing chain, the manufacturer concerned receives an ANSM injunction. These must be treated seriously, as they can have significant repercussions for a pharmaceutical company. In addition to the risks to reputation and consumer confidence, failure to comply with regulatory requirements can lead to severe legal consequences, including fines and suspension of marketing authorisation. It is therefore imperative for companies to act swiftly to safeguard the quality and compliance of their products. This article guides you through the essential steps you need to take to respond to an animal health decision and ensure your company’s compliance with regulatory standards. Reply to the ANSM advance letter On receipt of the preliminary inspection report (or a letter prior to the ANSM injunction), the offending company enters what is known as the contradictory period. During this phase, it is essential to manage communication with the inspection body effectively, responding fully and within the time limits set. The response must be carefully drafted, firstly describing the precautionary measures put in place prior to compliance. Secondly, the operator must provide precise information and present a clear action plan to remedy the shortcomings identified. This letter also provides an opportunity to express any objections or comments on the health decision.The ANSM then assesses the resources and protective measures taken to ensure that the corrective measures are appropriate and effective. If the solutions are sufficient, the injunction will not be adopted. If not, the company will be notified. Responding to the injunction by building an action plan The probationary period mentioned in the injunction takes effect on the day of notification of receipt of the injunction. At the same time, the document is also published on the national regulator’s website for public access. During this phase, it is essential to set up milestones to monitor progress towards compliance. For example, it is advisable to : conduct an internal audit; identifying gaps improving procedures applying best practice; train staff; strengthen quality control strengthen validation and qualification introduce traceability; implement a monitoring and continuous improvement procedure… The various possible outcomes of an injunction must be taken into account, whether they be regularisations, maintenance after the last deadline, cancellations or partial extensions. Once the action plan has been implemented, the operator must provide proof of compliance during a new inspection. This will determine how the rest of the procedure will proceed. LUGAN CONSULTING: EXPERTISE IN PHARMA PROCESSES Call on our experience to help you set up an action plan to comply with an ANSM injunction. Contact us Impact of an ANSM injunction Once the probationary inspection has been completed, the regulator may : Either declare that compliance has been fully achieved, in which case the injunction will be lifted. Or decide that insufficient action has been taken, and issue a formal notice. Failure to comply with a complete procedure leads to two types of penalty: Financial penalties They are applied in cases where the manufacturer fails to fulfil one of its obligations or repeats a fault. It should also be noted that they can be combined with any penalty payment, but not with criminal proceedings. Criminal penalties In the event of non-compliance with a public health order or where human health is directly endangered, the regulatory authority may assert non-compliance with the public health code and decide to take the company to criminal court. Faced with injunctions from the ANSM, responsiveness and vigilance are essential for pharmaceutical companies. By working closely with the regulatory authorities, companies can maintain the quality and compliance of their products, while preserving consumer confidence and ensuring public safety. By adopting a proactive and transparent approach, companies can turn regulatory challenges into opportunities for continuous improvement and sustainable growth. FACING AN ANSM INJUNCTION? Contact our services. LUGAN CONSULTING offers a comprehensive range of consulting, auditing, coaching and training services dedicated to the pharmaceutical industry. Contact us Source : ANSM : Décisions (Lignes directrices relatives aux suites d’inspection) Frank LUGAN PHARMACEUTICAL QUALITY EXPERT Autres infos Decarbonisation of pharmaceutical companies: how to get started? Décarbonation des entreprises pharmaceutiques : quelles pistes suivre pour l’initier ? Data Integrity : 8 steps to becoming compliant Intégrité des données : 8 étapes pour se mettre en conformité Pharmaceutical audit L’audit interne dans l’industrie pharmaceutique Team building : secret of success Cohésion d’équipe : le secret du succès ANSM injunction : how to react ? Injonction ANSM : comment y répondre

THE DRUG MANUFACTURING PROCESS : FROM RESEARCH TO MARKET LAUNCH The pharmaceutical industry is a complex field in which the research, development and marketing of a medicine follow a rigorous path. There are many stages in this circuit , all designed to ensure the efficacy, safety and quality of the products that reach patients. Let’s take a look at how the drug manufacturing works, from conception to availability on pharmacy shelves. Research and testing: 8 to 10 years The first stage in the development of a drug is pharmaceutical research. It often begins with the identification of unmet medical needs in the treatment of a specific disease. Once these needs have been clearly defined, scientists embark on a relentless quest to discover new molecules or develop innovative treatments. Patent registration The research process can take years, and each discovery goes through rigorous stages. First, a patent is filed to protect the new compound or technology developed. Next, preclinical trials are carried out to assess the drug’s toxicity, pharmacokinetics and potential efficacy in animal models. Clinical tests Once pre-clinical results are satisfactory, drug candidates are selected, followed by clinical trials. These tests on humans are conducted in several phases to assess the efficacy and safety of the drug in patients. This stage can take several years and involve thousands of participants. Approvals and production start-up: 1 to 3 years Once the clinical trials have been completed and the results analysed, the drug manufacturer must obtain regulatory authorisation to market the product. The Marketing Authorisation Application (MAA) is submitted to the relevant authorities, such as the European Medicines Agency (EMA) or the Food and Drug Administration (FDA). Validation of the marketing authorisation dossier requires a full presentation of research data, the results of clinical trials, and information on the manufacture and quality control of the drug. Transparency is essential at this stage, with open communication on the risks and benefits of the drug. Once marketing authorisation has been obtained, the price and reimbursement of the drug are set, often in collaboration with public health bodies and insurance companies. The industrial manufacture of the drug then begins, following Good Manufacturing Practices (GMP) to guarantee its quality, safety and efficacy throughout the production process. Life of Medicines: 20 years and over A medicine begins its active life as soon as it is made available on the market. For approximately 20 years, the patent holder has exclusive marketing rights. It is only once this period has elapsed that the property right expires. From then on, other manufacturers can produce generic versions of the drug. The end of the patent often marks the start of a period of increased competition and lower prices, which can benefit patients by making treatments more accessible. However, generic manufacturers must also comply with strict standards, while offering effective alternatives to branded products. This complex journey requires an unwavering commitment to science, regulation and, above all, the health and well-being of patients. Every step of the way must ensure that the medicines that reach their hands are safe, effective and of high quality. CHALLENGES OF INDUSTRIALISATION France is experiencing a boom in pharmaceutical industrialisation. The challenges facing companies in this sector are numerous. LUGAN CONSULTING can help you manage change and implement good manufacturing practices, so that you have every advantage on your side. 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