GMP News - Aseptic / Microbiology

12.01.11

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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05.01.11

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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08.11.10

PDA published Technical Report No. 50, Alternative Methods for Mycoplasma Testing

The PDA published the Technical Report No. 50, Alternative Methods for Mycoplasma Testing to help your analytical lab feel confident in the use of alternative methods. More details can be found here.

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08.09.10

Revision of USP <1235> Vaccines for Human Use - General Considerations

In the 2. supplement of USP33,  "General Informations" the USP published the revised chapter <1235> Vaccines for Human Use -General Considerations. Find more details.

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01.09.10

New WHO Draft on the Manufacture of Sterile Medicinal Products

With the revision of the WHO Technical Report Series (TRS) No. 957 in June 2010, the WHO's expectations on the manufacture of sterile medicinal products were published as a draft for an Annex 6 "Good manufacturing practices for sterile pharmaceutical products". Read more here.

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01.09.10

Inspection of Biological Drug Products

The FDA published 2010 the revised Compliance Program Guidance Manual – Chapter 45 Biological Drug Products: Inspection of Biological Drug Products (CBER). More details can be found here.

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04.08.10

New draft of ISO 14644-9 - Classification of Surface Cleanlinesss

The Institute of Environmental Sciences and Technology announced that the Part 9 of ISO 14644 is now a Final Draft International Standard (FDIS). Read more here.

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14.07.10

USP 1050 Viral Safety of Biotechnology Products Derived from Cell Lines of Human or Animal Origin - proposed Revision

The USP General Chapter 1050 - "Viral Safety Evaluation of  Biotechnological Products Derived from Cell Lines of Human or Animal Origin" is under revision.  After 10 years, the document will be updated now with respect to the developments in the field of viral clearance. Read more here.

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14.07.10

New Questions in the RMM Discussion Forum

The ECA RMM Working Group online discussion forum comprises some new questions of group members. For more information please go here.

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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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