From Parts 1, 2 and 3 of this post we have focused on the duties of the three key personnel named in EU GMP (the Head of Production, QC and the Qualified Person). We have also highlighted that there is no formal requirement for an Engineering Manager (or Department) AND a Quality Assurance Manager (or Department) in GMP. Most pharmaceutical manufacturing sites do actually have these people (and departments) and we have looked at the roles and responsibilities commonly performed by these in previous posts. There is also a final “key personnel” not named in GMP, namely the Human Resources Manager. Bearing in mind that in the manufacture and testing of medicines it is the employees themselves who have a massive impact on product quality and the quality system then the importance of the individual who looks after employees (usually the HR Manager) cannot be understated.
In a number of GMP courses that I have presented in the past we have looked at what the delegates think the Human Resources Manager’s role should be, bearing in mind the role is not formally defined in EU GMP. Their findings are below:
The Human Resources Manager (suggested duties from previous delegates)
- Management of the Training system
- Management of the Recruitment system
- Management of the Induction process
- Management of the Discipline procedure
- Establishment of objectives
- Control of the Appraisal system
- Control and approval of Organisation Charts, Job Descriptions and Training Records
- Payroll and expenses
- Organisation of training courses
- Personnel development
- Dealing with pertinent personal issues
- Monitoring of trends in general personnel performance
These are roles commonly performed by Human Resources departments. They are opinions from former GMP training course delegates, and should not be seen as a specific GMP requirement. Please let us know what you think. Are these similar to your own HR department? Do let us know.
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 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.
Training courses on Annex 1
There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.
Our 2-day course is updated for Annex 1 changes
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