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EMA GMP Chapter Draft Revisions Focus on Current Compliance Focal Points from Shared Facilities to Defect Investigations

Jan 30th, 2013

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The European Medicines Agency (EMA) has released draft revisions of four of its GMP chapters, intended to communicate its expectations regarding current compliance focal points including supply chain oversight, shared facilities, starting materials, lab method transfers, and investigating and reporting quality defects.

Released in mid-January for a six-month comment period were: ● Chapter 3, “Premises and Equipment” ● Chapter 5, “Production” ● Chapter 6, “Quality Control,” and ● Chapter 8, “Complaints, Quality Defects and Product Recalls.”

EMA notes that the revised Chapters 3 and 5 should be read in conjunction with a draft EMA guideline on “setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities,”  which was released for comment ten days earlier in January.  Comments on the guideline are due by the end of June.

A revision of Chapter 2 on personnel is now at the European Commission (EC) for review.  The chapter has been amended to incorporate the senior management responsibilities described in ICH Q10.

Also recently emerging from the EMA GMP pipeline have been two concept papers proposing the revision of Annex 15 on qualification and validation, and of Annex 17 on parametric release.  Both were published in November with comments due by the end of February.

Annex 1 on sterile products and Annex 16 on QP batch release are others that are now on the EMA revision radar screen.

Comments on the 2011 Annex 16 concept paper have been reviewed and a revision is being drafted with a release anticipated in early 2014.  A final revision of Annex 1, released in 2008, proved controversial, and EMA is considering either a further revision or a Q&A to address the concerns.

Another GMP focal point at the agency is an upgrading of its EudraGMP database regarding wholesale distribution authorizations, GDP certificates and manufacturer noncompliance statements to expand the usefulness of the database for both regulators and industry (IPQ “The News in Depth” January 28, 2013).

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See related IPQ stories:

Revamped EudraGMP Database May Make Public GMP Noncompliance Statements

FDASIA Title VII Empowers FDA in Supply Chain Arena; Congress Adds Other Tools to Help on Drug Shortages and Theft

New FDA Field Alert Report System Provides for Electronic Submission and Unique Identifiers

FDA Field Alert Reports Required for Anomalies That Occur During Distribution

Extensive Vetting of FDA’s Draft Process Validation Guidance Smoothes Its Transition to Final Form

EU Moves to Revise its GMP Annex 16 to Clarify QP Role

IPQ “Special Report,” January/February 2009

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