[Stability Testing related News – vol.1]

◆Elemental Impurities – An Update(28-Jan-13 USP Convention)

The provision in the General Notices making <232> and <233> applicable to all USP?
NF articles will be part of a General Notices revision that is scheduled to appear in USP 37?NF 32 with an official date of May 1, 2014.


Comparison (Matrix) of Former vs New Version of Chapter 1 of the EU GMP Guide Part 1 Effective from 31/01/2013(30-Jan-13 ECA)

Revised Chapter 1 of the EU GMP Guide is taking effect on 31 January 2013 The current version of Chapter 1 from 1 July 2008 applies until then.


◆Revision of the EU GMP Guide: EU Commission Publishes Proposals for Chapters 3, 5, 6 and 8(30-Jan-13 ECA)

On 17 January 2013, the EU Commission published the drafts of 4 revised chapters of the EU GMP Guide.
The publication had been expected for a long time now.
Deadline for comment is 18 July 2013.


◆Revisions of EU GMP Guideline(06,14-Feb-13 ECA)

The European Commission has revised numerous chapters of the EU GMP Guideline (Part 1).
This revision concerns, inter alia, chapter 3 “Premises and Equipment” sub-point 3.6 as well as chapter 5 “Production” points 5.17 – 21.
In addition to the changes in chapters 3 and 5 this guideline explains how pharmacological/toxicological data should become part of the risk assessment and the determination of exposure limits.

The European Commission DG Health & Consumers has published the revised EU-GMP Chapter 8 on Complaints, Quality Defects and Product Recalls.
Quality Risk Management now plays an important role in the revised chapter and the “principles should be applied to the investigation and assessment of quality defects and to the decision-making process in relation to product recalls and other risk-reducing actions”.
In the case of a quality defect which “may result in the recall of the product or an abnormal restriction in the supply”, all competent authorities concerned should be informed.


◆Guidelines for formalised Risk Assessment of pharmaceutical Excipients issued(13-Feb-13 ECA)

Recently the EU Commission issued draft guidelines on the formalised The document “Guidelines on the formalised risk assessment…” with the Guideline drafts is available on the EU Commission’s News site of the EU Commission – open for consultation until 30 April 2013.


◆WHO GMP approaching EU-GMP(13-Feb-13 ECA)

The current good manufacturing practices (GMP) for pharmaceutical products of the WHO are going to be updated.
The current title of the WHO document “Quality Assurance” changes to “Pharmaceutical Quality System”, and the changes reflect another step towards harmonisation in global GMP standards.

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