EU GMP states that Quality Control (clause 1.9) “is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures”. In essence, QC is a sampling, testing, monitoring and checking activity.
GMP also defines the routine duties for the Head of Quality Control (2.8) to:
- Approve or reject materials.
- Ensure all testing performed.
- Approve specifications, instructions and procedures.
- Approve and monitor contract analysis.
- Quality and maintain their department, premises and equipment.
- Ensure validations are performed.
- Initial and ongoing training of personnel.
In addition, the Head of QC has some shared responsibilities with the Head of Production (2.9):
- Authorisation of written procedures and other documents.
- Monitoring and control of the manufacturing environment.
- Plant hygiene.
- Process validation.
- Training.
- Approval and monitoring of suppliers.
- Approval and monitoring of contract manufacture.
- Designation and monitoring of storage conditions.
- Retention of records.
- Monitoring of compliance to GMP.
- Inspection, investigation and taking samples.
- Participation in management reviews.
- Ensuring that a timely and effective communication and escalation process exist.
EU GMP does not specifically require a Quality Assurance Department or Manager, but you must have a QA System (Chapter 1 – Principle). It does say at 2,5 of EU GMP that “additionally depending on the size and organisational structure of the company, a separate Head of Quality Assurance or Head of the Quality Unit may be appointed’. So, you might, and almost certainly will have a QA department, even though EU GMP does not define the roles of QA.
Most pharmaceutical manufacturing sites have a QA department, but problems have occurred with assigning the QA Department tasks that were originally intended for QC. It is also worth pointing out that the words “Quality Assurance” are not mentioned in 21 CFR 211 either.
It is not uncommon for the non-laboratory tasks of QC to be delegated to QA. Non-laboratory tasks of QC could be listed as in italics below.
Duties of QC (including those shared with the Head of Production) – all tasks:
- Approve or reject materials.
- Ensure all testing performed.
- Approve specifications, instructions and procedures.
- Approve and monitor contract analysis.
- Quality and maintain their department, premises and equipment.
- Ensure validations are performed.
- Initial and ongoing training of personnel.
- Inspection, investigation and taking samples.
- Authorisation of written procedures and other documents.
- Monitoring and control of the manufacturing environment.
- Plant hygiene.
- Process validation.
- Training.
- Approval and monitoring of suppliers.
- Approval and monitoring of contract manufacture.
- Designation and monitoring of storage conditions.
- Retention of records.
- Monitoring of compliance to GMP.
- Inspection, investigation and taking samples.
- Participation in management reviews.
- Ensuring that a timely and effective communication and escalation process exist.
If these duties are grouped together you get a list like this:
- Approve specifications, instructions and procedures.
- Ensure validations are performed.
- Initial and ongoing training of personnel.
- Authorisation of written procedures and other documents.
- Monitoring and control of the manufacturing environment.
- Plant hygiene.
- Process validation.
- Training.
- Approval and monitoring of suppliers.
- Approval and monitoring of contract manufacture.
- Designation and monitoring of storage conditions.
- Retention of records.
- Monitoring of compliance to GMP.
- Participation in management reviews.
- Ensuring that a timely and effective communication and escalation process exist.
These tasks can be delegated to QA. This is not a problem, as GMP permits delegation (2.3). However, if this is all that QA do (i.e. the non-laboratory tasks of Quality Control) then are they really “Quality Assurance”? They are QC by another name! Don’t forget, QC is a sampling, testing, monitoring and checking activity, and many of the activities above are just that. Some are “Quality Assurance” activities, such as monitoring outsourced activities (contract analysis and manufacturing), monitoring suppliers, validation and training, but a QA department needs to do a whole lot more than this in order to really be a department dedicated to Quality Assurance.
I hope you find these thoughts interesting. Please feel free to comment. For details of our courses in this area select this link: QMS Courses
THIS ARTICLE WAS FIRST PUBLISHED IN 2012 AND MOST RECENTLY UPDATED IN SEPTEMBER 2022.
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.
Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.
While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.
About the author
Andy Martin
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
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Where we can put Validation manager, Project Manager, Plant Manager, QC Manager and Product Manager ?
What are there roles and responsibilities ?
The only roles defined in EU GMP are for the Heads of Production,Quality Control and the Qualified Person. See Chapter 2. Tasks may be delegated in some cases. See Chapter 2 clause 2.2.
Thanks a lot for that blog article.Really looking forward to read more. Many obliged.