I perform a number of audits throughout the year. Most are supplier audits but some are internal audits. In order to make the audits as efficient as possible I recommend good planning for the audit – rather than just turning up on the day and “going with the flow”.
Firstly – make contact with your host (auditee) well before the audit. This starts the communication process with them. During this time you can discuss (via telephone or email) any domestic arrangements, such as site location, local hotel, times and dates, etc. From these early discussion an audit programme should be produced and sent to the auditee at least 2 weeks beforehand. This allows them to understand where you are likely to go during the audit.
Secondly – ask to see some documents before the audit as part of the preparation stage. This significantly helps the audit preparation and highlights any areas that may need additional focus or perhaps less focus. For supplier audits I will always ask to see a Site Master File and a Quality Manual (if these exist within the organisation). A Site Master File (SMF) is a GMP document that describes the site, major activities, key personnel, site layout, etc. This gives you a good idea of the physical structure of the site and tells you what buildings are located where. It is always good to know if everything is located on a single site or multiple sites and gives you an appreciation of the physical layout. A Quality Manual (QM) is an ISO 9001 document that described the whole Quality Management System. This is becoming more of a GMP requirement, and is good to see as it should describe how the QMS operates. In addition I also ask to see an Organisation Chart and a Master List of Documents. All of these help me to get an initial understanding of the organisation, allows me to arrive well prepared and makes for a more efficient audit. I do not worry too much if they fail to provide any of these documents, but it is useful to try and review these beforehand.
For internal audits a similar approach is also suggested. You should easily be able to see any procedures for the area you are auditing, get a list of personnel who work in the area (to have their training records and job descriptions ready) and see if there are any major quality issues associated with the area. It is always good to see what changes, problems and deviations have occurred in the area in the past year – as these may be worth reviewing for effective implementation during the audit.
All of the above does not take too much time to request and then review beforehand. You may not always get these documents, but as they say – “if you don’t ask then you don’t get”. Believe me – it is an investment of your time that does make for a much better audit.
I hope you find this useful. All comments will be valued.
For a more detailed article on this topic and a checklist select the text in blue.
Good luck with your auditing.
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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Our 2-day course is updated for Annex 1 changes
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Dear Mr. Parry,
it is really worth reading. would you help me by sending an SOP on how to get prepared for inspection (handling of reguloatory inspections.)
thanks in advance.
regards,
ilyas patel
COMMENTS ALSO RECEIVED FROM LinkedIn:
Audit and especially inspection prep is asking more and more of our time.
Not only do we get more inspections and audits, but also the inspectors and auditors require more up front documentation (SOPs, P&ID, SMF, PQRs, etc) to better prepare for and be more efficient during the inspection. Some also request (or impose) the documents to be translated into their language.
What are your experiences? Till what level do you accept and fulfil inspector’s wishes and where does it stop?
Posted by Johan Vandaele