Concept paper Archives - European Industrial Pharmacists Group (EIPG)

Lessons learnt to transition from Horizon 2020 to the new FP10

by Giuliana Miglierini The European Commission published the ex post evaluation of Horizon 2020 (H2020), the FP8 framework programme for research and innovation (R&I) run in years 2014-2020. The report identifies several areas of possible improvement, which may be taken into Read more

Approvals and flops in drug development in 2023

by Giuliana Miglierini Approvals and flops in drug development in 2023 The European Medicines Agency published its annual highlights, showing 77 medicines were recommended for marketing authorisation, and just 3 received a negative opinion (withdrawals were 19). In 2023 some highly expected Read more

Webinar: Oral Colon Drug Delivery - Design Strategies

EIPG webinar Next EIPG webinar is to be held on Wednesday 21st of February 2024 at 17.00 CET (16.00 GMT) in conjunction with PIER and University College Cork. Anastasia Foppoli, will discuss on the various approaches and the general aspects Read more

Insights to the Industrial Pharmacist role for the future

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A concept paper from EIPG Advisory Group on Competencies vol.2, 2023

This paper is an update of the previous EIPG paper and intends to raise awareness of the changing requirements of the professional profile of Industrial Pharmacists for Pharmacists at any stage of their career who intend to pursue careers in the Pharmaceutical Industry and those involved in the education of Pharmacists to update the education provided accordingly.

This paper is aimed at Pharmacists at all stages of their careers, including Pharmacy students, early career Pharmacists and Pharmacists working in a sector other than the Pharmaceutical Industry. The considerations presented are based on the collective expertise of the group. Therefore, this paper should be consulted as a starting point and is not a complete discussion of Pharmacist knowledge, competencies and skills nor a comprehensive overview of the Pharmaceutical Industry.

The EIPG with responsibility for the Pharmaceutical World, decided to continue the Project of the Advisory Group of Competencies. They used as a baseline document the first version of the position paper from 2020, in order to update the missing or outdated areas in the Pharmaceutical Industry. By examining some new trends and evolutions in drug science and technology, they explained the opportunities and challenges that are likely to arrive. All this information is intended for those at any stage of their Pharmacy career who want to understand their potential within the Pharmaceutical Industry.

The target of the project is to evaluate and determine the roles where the Industrial Pharmacist will work in the future and what knowledge, competencies and skills are needed to fulfill the requirements in these future roles. It is a shared understanding that there are gaps in the current curricula, but academia cannot cover all the needs of the Pharmaceutical Industry. For this reason, the Advisory Group have made some recommendations and proposals to recognize and fill those gaps. Hence, Pharmacists will have a clear view of the various roles in the pharmaceutical life cycle, and will be able to identify areas to develop on order to secure selected roles in the industry. This document may also be helpful in differentiating Pharmacists from other professions when applying for these roles.

You may find the full paper here.

A concept paper on the revision of Annex 11

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This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP) guideline. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The current version was issued in 2011 and does not give sufficient guidance within a number of areas. Since then, there has been extensive progress in the use of new technologies.

Reasons for the revision of Annex 11 include but are not limited to the following (in non-prioritised order):

  • The document should be updated to replace relevant parts of the Q&A on Annex 11 and the Q&A on Data Integrity on the EMA GMP website
  • An update of the document with regulatory expectations to ‘digital transformation’ and similar newer concepts will be considered
  • References should be made to ICH Q9
  • The meaning of the term ‘validation’ (and ‘qualification’), needs to be clarified
  • Guidelines should be included for classification of critical data and critical systems
  • Important expectations to backup processes are missing e.g. to what is covered by a backup, what types of backups are made, how often backups are made, how long backups are, retained, which media is used for backups, or where backups are kept
  • The concept and purpose of audit trail review is inadequately described
  • Guidelines for acceptable frequency of audit trail review should be provided
  • There is an urgent need for regulatory guidance and expectations to the use of artificial intelligence (AI) and machine learning (ML) models in critical GMP applications as industry is already implementing this technology
  • FDA has released a draft guidance on Computer Software Assurance for Production and Quality System Software (CSA). This guidance and any implication will be considered with regards to aspects of potential regulatory relevance for GMP Annex 11

The current Annex 11 does not give sufficient guidance within a number of areas already covered, and other areas, which are becoming increasingly important to GMP, are not covered at all. The revised text will expand the guidance given in the document and embrace the application of new technologies which have gained momentum since the release of the existing version.

If possible, the revised document will include guidelines for acceptance of AI/ML algorithms used in critical GMP applications. This is an area where regulatory guidance is highly needed as this is not covered by any existing regulatory guidance in the pharmaceutical industry and as pharma companies are already implementing such algorithms.

The draft concept paper approved by EMA GMP/GDP IWG (October 2022) and by PIC/S (November 2022) and released for a two-months consultation until 16 January 2023.