GMP News - Aseptic / Microbiology

14.07.10

Revision of EP chapter 5.1.6. Alternative Methods for Control of Microbiological Quality

European Pharmacopoiea: The Modern Microbiological Methods Working Party published a questionnaire to the revision of Chapter 5.1.6 “Alternative Methods for Control of Microbiological Quality Rapid Microbiological Methods. More details can be found here.

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16.06.10

FDA Guideline to Reduce the Risk of Transmission of CJD and vCJD by Blood and Blood Products

In May, FDA published the new Guidance for Industry "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products". More information can be found here.

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29.04.10

Public Consultation on Annex 2 started

The European Commission published the revised Draft of Annex 2 "Manufacture of Biological Medicinal Substances and Products for Human Use" for the second pubic consultation with deadline for comments 15th July 2010. More details can be found here.

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29.04.10

EMA publishes Draft Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials

To provide a guidance for a harmonised quality documentation of biological Investigational medicinal products in clinical trials, the EMA published the draft of a new guideline. More details can be found here.

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14.04.10

Survey: Revision of Chapter 1 of the EU GMP Guide

Survey: Recently a draft revision of Chapter 1 (Quality Management) of the EU-GMP Guide has been published with some comprehensive changes. We would like to get your opinion on the proposed changes. Here you find our survey.

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14.04.10

FDA Guidance for Submission of Documentation in Applications for Parametric Release

The FDA published the Guidance for Industry of "Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes", providing recommendations to applicants on information to include in support of parametric release for sterile products. More details can be found here.

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08.04.10

Real Time Release Testing (Parametric Release) - EMA publishes new Guideline Draft open for Consultation

In February the EMA published the draft of a new Guideline for Real Time Release Testing (formerly Guideline on Parametric Release). The draft is open for comments until end of August 2010. More details can be found here.

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31.03.10

Microbiological Control of Herbal Drugs

With the European Pharmacopoeia Supplement 7 new microbiological methods for herbal drugs in were issued. Get the details here.

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24.03.10

FDA publishes finalized Guidance for Characterization and Qualification of Cell Substrates and Other Biological Materials

With the Guidance for Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, the FDA finalizes the Draft Guidance from 2006. Find more details here.

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03.03.10

Review of Supplement 6.8 European Pharmacopeia 6th Edition

The results of  a polyphasic ATCC study, regarding molecular and physiological data, caused a change in the European Pharmacopoeia Supplement 6.8. Read the details here.

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27.01.10

FDA Publishes Statement on the Frequency of Media Fills

In the document "Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs", the FDA publishes statements on topical subjects. Recently, the authority published a statement on the number of annual media fills in relation to the number of shifts and depending on the use of isolators. Find more here.

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13.01.10

Revision of EU GMP Guide Chapter 1 Published

The European Commission has published a proposal for the revision of Chapter 1 Quality Management Systems of the EU GMP Guide. The new draft includes comprehensive changes. Find the details here.

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13.01.10

Interpretation of the New Annex 1 to the EC GMP Guide by PIC/S

The revision of Annex 1 to the EC GMP Guide on sterile medicinal products was quite controversial. How the changes should be interpreted and implemented from the inspectors' viewpoint is presented in a new PIC/S "Recommendation GMP Annex 1 Revision 2008, Interpretation of the most important changes for the manufacture of sterile medicinal products" PI 032-2. Read more here.

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