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.
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.
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.
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.
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.
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.
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.
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.
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.