GMP News - Aseptic / Microbiology

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Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, the FDA finalizes the Draft Guidance from 2006.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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