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Active Ingredient and Starting Material Supply Chains in Focus in Draft Revision to EU GMP Guide Chapter 5

Dec 1st, 2010

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The European Commission (EC) has released for comment a revision to EU GMP Guide Chapter 5 on production that provides new requirements for control of active ingredient and starting material supply chains, including reports documenting periodic supplier audits for inspector review.

A new section on subcontracting laboratory analysis of starting materials by drug product manufacturers, which focuses on the contract agreement and periodic auditing of the contract labs, has also been added.

Changes were made, the introduction to the draft explains, to “reflect the legal obligations of manufacturing authorization holders to ensure that active substances are produced in accordance with GMP.”  Comments are due by February 28, 2011.

Changes to several EU regulations that govern technical agreements, outsourced activities, active pharmaceutical ingredient (API) supply chains, and the storage and transit of medicines are in progress and are beginning to be released for public consultation.

[Editor’s note:  Concept papers on changes to the EU GMP Guide Chapter 6 on quality control laboratories and on storage conditions during transport for medicinal products and APIs have now been released.  Stay tuned for IPQ analysis of these documents coming soon.]

Commenting on the EU GMP revision effort at a Xavier University conference on global outsourcing in June, MHRA GMP Inspector Rachel Carmichael emphasized that changes to the EU regulations “will significantly affect anybody who wants to supply to Europe.” (IPQ “In the News” June 16).

The EC recently released for comment a revision to Chapter 7 of the EU GMP Guide on outsourced activities that expands the scope of coverage and incorporates quality system and risk management principles from ICH Q9&10.  Chapter 7, formerly “Contract Manufacture and Analysis,” has been re-titled “Outsourced Activities” to reflect an expansion of its scope to cover all GMP-related outsourced activities (IPQ “In the News” November 22).

The EU effort to update its GMPs on supply chain requirements for active ingredients and starting materials is reflective of a stronger focus on these areas in the ICH countries.  Like the EU, the US has been taking steps to strengthen its supply chain rules (IPQ “In the News” June 16).

Also in the US, a recent revision to the preapproval inspection guide places a “special emphasis” on supplier qualification (IPQ “In the News” November 15).

Internationally, the ICH Q11 Expert Working Group (EWG) has been wrestling with balancing regulatory transparency with industry flexibility in defining the starting material as it moves forward in drafting the guideline on drug substance development and manufacturing (IPQ “In the News” July 9).

[The proposed changes to EU GMP chapter 5 are analyzed for subscribers beginning on page 2.  To subscribe to IPQ, click here.]

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