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What’s new in the latest version?

The EU GMP Chapter 5 on Production is currently being reviewed.  A draft update document is currently available.  This article is a commentary on the DRAFT version currently in circulation.  Many of the suggested updates are in-line with existing good practices.  Some of the main suggested changes are summarised below.  You should refer to the actual document, Chapter 5 Draft, for the full details.  There is no news on if and when this update comes into force yet.

Prevention of cross-contamination (5.18 & 5.19)

No change here – but much discussion going on about potentially changing this in the future (see first page).

Increased focus on control of suppliers and starting materials

Wording changed to include coverage of the whole supply chain rather than just “suppliers” (5.25, 5.27 & 5.31), especially with regard to brokers and transportation of materials.

The chapter is updated so that the pharmaceutical manufacturer approves Active Pharmaceutical Ingredient (API) manufacturers, importers and distributors.  This is linked to the need to ensure APIs are made according to API GMP, but this was not mentioned formally as a specific GMP clause before.

Formalisation of approval of suppliers (via a procedure) and records of discussion of all quality issues with suppliers (5.25 & 5.26).  Again, just tightening up what many sites will do with controlling suppliers, but there is now a requirement to have a documented procedure for supplier approval and keeping any records of discussions and correspondences with suppliers.

First mention of auditing of API suppliers and some excipient suppliers (5.26).  Up until now you needed to “approve suppliers”, one mechanism could be to audit them but the word “audit” was not used in GMP before.   Auditing of suppliers is only suggested in current Annex 8, but only with regard to reduced sampling of incoming materials.  This new requirement will put an increased regulatory focus on exactly how sites approved their suppliers.

Audit reports of these suppliers to be available to Regulatory Inspectors (5.26).  This will allow the inspectors to review audit reports if they want to.  It will be worthwhile ensuring any confidentiality agreements signed with suppliers prior to performing an audit actually permit this.

Reminder that approval of suppliers is the responsibility of the Heads of Production and QC.  This is already covered in the shared duties of the Heads of Production and QC (Chapter 2.7)

Increased control of the testing of incoming materials.

New guidance on how and when you can use analytical results or Certificates of Analysis (CofA) from suppliers (5.31).  You still need to do an identity test of incoming materials, but you can use a supplier’s analytical results if they are audited, meet GMP and licenced conditions, the CofA is signed by an appropriate person and this person is also signing that each batch meets agreed requirements.

In addition, full analysis required on 3 batches is required prior to potentially reducing the amount of in house testing.

I hope you find this short summary useful.  If you want to make a comment please do so.

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 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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