The first change, and arguable the most significant, is the change in title of the chapter from Contract Manufacture and Analysis to Outsourced Activities. This is very significant as it clearly broadens the scope of the chapter from the outsourcing of production, packaging and testing to controlling the outsourcing of all GMP related activities. There are a number of activities that a GMP purist could argue were out of scope of the current chapter. Typical activities that are outsourced by many organisations that would now become within scope of this chapter include calibration, transport, maintenance, cleaning, security, training, off-site document storage, secure pharmaceutical waste disposal, pest control, validation and qualification and even the use of consultants. These are just examples, but are used to show the broader scope of the chapter that can now be used to include activities that were not included before. In other words, any GMP activity that an organisation would normally be expected to do itself (in order to meet GMP requirements) that it chooses to outsource are covered. It will be therefore worthwhile checking that both you and your 3rd parties (contract acceptors) are meeting proposed requirements.
Main changes to the Chapter.
Increased requirements to review and monitor the performance of the 3rd party by the contract giver. This should be based on risk (7.3 and 7.7). This means an increased responsibility for the oversight of outsourced activities.
A bigger emphasis is placed on control of changes at the 3rd party to ensure that the contract giver is suitably informed of such changes (7.11). It will be therefore worth ensuring that suitable and appropriate change control processes are in place at the3rd party.
You also see the first mention of communication between contract acceptor and contract giver (7.12). This is likely to link with any changes and problems that may occur.
Finally there is now also a requirement to permit audits of 3rd party suppliers to be defined in the contract (7.15). The word “audit” is much stronger, as the word “visit” was used before, which could mean many things!
This is just an overview of the latest draft requirements. It is by no means an exhaustive comparison and there are many wording changes and new words used (such as knowledge management) that are open to interpretation. The main thing I think to consider is the broader coverage of activities beyond manufacturing and testing that the new chapter covers, and the need to ensure that both your 3rd parties and your own organisation are meeting the proposed new requirements.
As an overview I hope you find this useful. Please feel free to add your comments.
If you want to know more about how to audit suppliers of outsourced activities, please consider our IRCA registered Pharmaceutical Lead Auditor training course. Details are on our main website.
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.
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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I absolutely agree with you. The prerequisite of a successful audit is – how well the auditor is prepared for it, how much information he/she have on the company to be audited, for what purpose the audit is conducted, etc. I also perform a lot of audits – mostly our suppliers.