Firstly, and going back to basics, I always look at what GMP actually states about CVs and having copies in Training Records. Well the current EU GMP Chapter 2 on “Personnel” says nothing about CVs at all. Neither does USA GMP (21 CFR 211). The nearest you can get to finding anything is that 21 CFR 211 has a requirement (211.34) to have records of consultants used – but these are, of course, not employees and therefore this does not help here.
I have seen a number of organisations where they have simply asked employees to add their CV to their training records. This has causes a number of difficulties in full implementation, which on the grand scheme of things is not the end of the world, but I thought I would share them with you.
Not everyone has got an up-to-date CV
Let’s face it – you only ever update your CV when you are looking for a new job, especially with a new organisation. If you have been happily working for your current firm for over 20 years then you may not have a current CV and have no interest in writing one.
CVs have confidential information on
A normal CV will contain all of your work experience, but will often detail your home address, phone number, marital status, number of children and even hobbies. These may be important factors when applying for a new job, but are of little relevance to GMP. Because such information is often deemed as “confidential” then it is wrong to put this information in a Training Record, which is an auditable/ inspected quality record for all to see.
Training records don’t give the full story
With Training Records you normally record the training that has occurred whilst employed by the organisation. They don’t capture the training and experiences a person had before they started to work for the organisation, so there clearly is an advantage of having some form of CV that gives a broader coverage of what education, experience and jobs/ responsibilities a person has had.
The CVs are held in the Human Resources (HR) office
Because CVs often do have some degree of confidential information then they may be held in individual’s private records in the HR department. I recently actually looked at some of these when visiting a firm only to find that the CVs that they had on file were the actual ones sent in when the person applied for the job. These were also used at the interview and were covered in highlighter pens, correction fluid, scribbled questions to ask and even areas of potential strengths and weakness. They were certainly records that you would not want to show a Regulatory Inspector!
I think that there is a way to have CVs that are open, auditable, non-confidential and can comfortably be kept in public Training Records. These should be the same as a conventional CV (used when applying for a job) but with all of the private information removed. In other words they just state the education and experience of an individual and do not include their home address, the fact that they have 3 adorable children, that they have been happily married to Catherine for over 15 years and love stamp collecting!
However – do remember to keep these up-to-date, so they should capture job roles and promotions whilst at the current organisation, so you can see what experience people have had whilst within the employ of a firm.
I hope that this is helpful. Feel free to comment on what you do at your organisation with CVs. Incidentally, curriculum vitae is a Latin expression which can be loosely translated as (the) course of (my) life. Also – the plural of Curriculum Vitae is actually Curricula Vitae and not Curriculum Vitaes – but it just doesn’t look right!
Feel free to follow me on Twitter (@Inspiredpharma) and LinkedIn (Dominic Parry).
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
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