GMP NEWS 2009

Validation of USP Methods - Incorporation of ISO Terms!

The revised and recently published general chapter <1225> - Validation of Compendial Methods - in the first supplement of the USP 32 describes the requisite performance characteristics that should be considered to prove the validation of a method in the case of its submission to the Pharmacopoeia. Find more information here.

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FDA issues new Draft Guidance regarding "Genotoxic and Carcinogenic Impurities in Drug Substances and Products"

A new FDA guidance draft relative to "Genotoxic and Carcinogenic Impurities in Drug Substances and Products" makes recommendations for characterising these impurities and for the limits in connection with the development phases as well as for already authorised drugs. Get the details here.

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FDA Guideline on Drug Stability Studies of Animal Drugs

The Center for Veterinary Medicines (CVM) at the FDA published a comprehensive guideline on the testing of drug stability of animal drugs and medicated feed products. Read more.

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PIC/S publishes new Aide-Memoire on the Inspection of Manufacturers of Active Pharmaceutical Ingredients

In January 2009, the PIC/S (Pharmaceutical Inspection Convention Co-Operation Scheme) published a new Aide-Memoire to provide guidance for inspectors inspecting API manufacturing sites. Read more.

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Implementation of the Variations Regulation: 2 Public Consultation Papers published

As part of the implementation of the Variations Regulation, EMEA has published 2 Public Consultation Papers. Read more.

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ECA's 10th Annual Review (2008)

The development of the European Compliance Academy (ECA) is a true success story - since its inception in 1999, the ECA has been experiencing a steady increase in awareness and interest and was able to accomplish many goals. This year, the organisation commemorates its 10 year anniversary. Read more in the ECA Annual Review.

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Out-of-Specification Results and Failure Investigations in current FDA Warning Letters

In the years 2008 and 2009, there has also been a multitude of FDA Warning Letters concerning out-of-specification results and failure investigations. Read more about these here.

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CDER Update - FDA Recalls

The Center for Drug Evaluation and Research (CDER), the FDA center responsible for chemical drugs, protein drugs and monoclonal antibodies regularly publishes statistics for the respective fiscal year. Find more information on an interesting statistic concerning the GMP sector - here.

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New PIC/S Guide for the Inspection of Packaging Processes and Facilities

In January 2009, the PIC/S has published a new Aide-Memoire to provide guidance for inspectors inspecting packaging processes. Read more.

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GMP Guideline Manager with new web-based software - free of charge for ECA Members

The new GMP Guideline Manager release 11.0 is now a web-based solution and thus does not require additional software to be installed. To find out more about the advantages the new release combines, please read here.

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ICH Publishes Contact Address for Submitting Questions on Q8, Q9 and Q10

The ICH has decided to publish an official contact address to which everybody can send questions regarding the implementation of Q8, Q9 and Q10. These questions are then forwarded to the members of the working groups. Here you can read more.

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EMEA publishes Questions and Answers on the Quality of IMPs

EMEA has published new Q&As on the Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials. Read more.

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European Recommendations on Dissolution Testing

In one of last year's PHARMEUROPA issues, the draft for a new general chapter titled "Recommendations on Dissolution Testing" was published. Read more here.

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New USP General Chapter on Residual Solvents - Implementation by the FDA?

The new USP General Chapter <467> on "Residual Solvents", which came into force on 1 July 2008, has caused uncertainty in the industry. Read more about two FDA statements on this topic.

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Results of the Survey: "How Will You React to the New FDA Guidance on Process Validation?"

Read the results of the survey: "How do firms intend to perform their process validation in compliance with FDA requirements in the future?" Some of the results are very interesting.

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Annex to ICH Q8 Pharmaceutical Development reached Step 5

The Annex to ICH Q8 Pharmaceutical Development reached Step 5 providing further clarification of key concepts outlined in the core guideline. In addition, this annex describes the principles of Quality by Deign (QbD).  Read more.

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FDA Guidance on Standardised Identification for Medicinal Products

Within the framework of the Food and Drug Administration Act of 2007 (FDAAA), the FDA has published another draft guidance. Against the background of fighting counterfeit medicines, this paper gives introductory information on standardising the numerical identification of medicinal products. Read more.

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Update of the PIC/S Recommendation on the Validation of Aseptic Processes

The PIC/S recommendations PI 007-4 "Validation of aseptic processes" were updated with regard to the required incubation conditions for media fills on 7 February 2009. Read here for further details.

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EMEA publishes Questions and answers on the preparation of applications for a PIP and/or waiver

The European Medicines Agency (EMEA) has published a comprehensive Q&A document on the preparation of applications for a PIP and/or waiver, eleven pages long, with answers to the following 21 questions.

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EMEA publishes Strategy Paper on 'Acceptance of Clinical Trials conducted in third Countries'

The European Medicines Agency (EMEA) has set out its strategy in relation to the acceptance, as part of a marketing-authorisation application, of clinical trials conducted in third countries. Read more.

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