GMP NEWS 2011

New EU GMP Guide Chapter 4 on Documentation

The final Chapter 4 ("Documentation") of the EU Guideline to GMP has now been published and will come into operation on 30 June 2011. Some important changes were included. Get a summary here.

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New EU GMP Guide Annex 11 "Computerised Systems"

In Europe the EU GMP Guide Annex 11 "Computerised Systems" is the regulatory basis for GMP regarding IT systems in the pharmaceutical industry. The new version was issued on 3 January 2011 together with the EU GMP Guide Chapter 4 "Documentation". It will become effective on 30 June 2011. Read more.

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Compliance Policy Guide: RFID Studies and Pilot Programs for Drugs

FDA is extending the expiration date of compliance policy guide (CPG) Sec. 400.210 entitled ‘‘Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs’’ to December 31, 2012. Read more here.

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ICH Q8, Q9 und Q10: new Q&A Document published

The ICH Quality Implementation Working Group (Q-IWG) has issued volume 4 of the ICH guideline Q8, Q9 and Q10 - Questions and Answers Document. Read more.

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New FDA Guidance: Codevelopment of Investigational Drugs for Use in Combination

FDA's Center for Drug Evaluation and Research (CDER) has published a Guidance for Industry on the codevelopment of two or more novel  drugs to be used in combination to treat a disease or condition. Read more.

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USP <1113> Microbial Identification - In Process Revision including a title change

The United States Pharmacopeia revises chapter <1113> about microbial characterisation, identification and strain typing including a change of chapters name. Read more here.

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New Best Practice Guides for the Submission and Processing of Variations published

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h), has published the latest version of its Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. Read more.

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FDA Inspections: Current Initiatives

The globalization of the pharmaceutical supply chain and the quality issues that have arisen because of that globalization, the FDA initiative "Pharmaceutical Quality for the 21st Century" and resource constraints that all Health Authorities are feeling are all changing the way FDA is viewing their mission to protect the American consumer.  Click here to get an overview about the current initiatives.

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Complete Revision of USP Chapter <1116> including updated Cleanroom Classification

In the USP Pharmacopeial Forum Volume 36, No. 6, the chapter <1116> "Microbial Evaluation of Clean Rooms and other Controlled Environmentsis" has been published with the status "In-process-revision". Read here more about the proposed changes.

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FDA issues Guidance on Public Comment Procedures at Advisory Committee Meetings

The FDA has issued a final guidance for people who wish to comment during the agency’s advisory committee meetings. Read more.

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