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.

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