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Is Germany moving toward a UK style QP study guide?

In the UK there is evidence of a shortage of Qualified Persons with pharmaceutical companies finding it difficult to find suitable candidates to fill vacancies.  With many of the original raft of Transitional QPs retiring and only approx. 30 new QPs joining the registers through the UK permanent provisions each year it has been suggested that the UK process for training and assessment of QPs must be revised.

A great emphasis is placed on experience in a wide variety of subjects and in depth understanding of Quality Systems and manufacturing of pharmaceutical as exemplified in the UK QP Study Guide.

Many other EU countries have a more liberal interpretation of the requirements laid down in the relevant directives (2001/82/EC, 2001/82/EC, 2001/20/EC).  For example, in Italy, the experience requirement (one year for pharmacists, two years for other disciplines) must be undertaken in a QC laboratory on a site with an MIA.  To become a QP, the applicant must have a suitable degree, the QC experience and then apply to be named on a licence.  No requirement for manufacturing or quality systems experience, no in depth assessment of their knowledge, experience or understanding.

The situation is currently similar in Germany, yet, even here, there is a shortage of QPs.

The German QP Association (GQPA) has published a position paper suggesting that the lack of consistency regarding the expectations of QPs by the different competent authorities across the country has led, in part, to this problem.

The other aspect discussed in the paper is the lack of knowledge of QPs of manufacturing and quality systems, particularly when they first start in the role.

The suggestion includes a distinction between ‘essentials’ for the QP, to be gained within the two years of practical activities prior to recognition, which would include:

  • Legal requirements – Knowledge of relevant EU legislation and guidelines
  • Quality Control
    • Product and process knowledge
    • Deviations / RCA
    • OOE/OOT/OOS process
  • QA system and basic GMP
    • Documents
    • Batch record review
    • Error
    • Complaint, return, recall
    • Change management
    • AQR/PQR
    • Regulations
    • Audits
    • Risk Management
    • Fundamentals of drug approval / pharmacovigilance
  • Production
    • Active Ingredients
    • Products
    • Qualification
    • Validation
    • Process
    • Documentation
    • Packaging
  • General legal aspects and issues
  • Fundamentals of pharmaceutical technology / Formulation
    • Fundamentals of pharmacology / technical knowledge of products produced
  • Basics in IT
  • General Skills / characteristics
    • Management Skills
    • Soft skills such as social skills

The additional areas “add-ons” should be able to take place after recognition of the expertise and would depend on the area of expertise of the individual QP, these include:

Practical experience in any specialist area such as radiopharmacy or ATMP

  • Continuous expansion of expertise
  • Manufacturing
  • QA system
  • Authorisation processes
  • Others, e.g. financial aspects
  • Management and soft skills
  • Quality management

The position paper is a detailed proposal for significant changes to the expectations for not just the training for German QPs, but also the role that they play within the structure of the manufacturing sites on which they work.

What does this mean for the UK process?  Well, I would say that the rigorous process we have is here to stay for a while.  With the update to Annex 16 and the responsibility / accountability inherent in the role of the Qualified Person I certainly would want to have as much knowledge and experience as possible.

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Alex Hern, Sanofi.


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