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Volume 10 - Clinical trials. Concerning Veterinary Medicinal Products: Volume 5 - Pharmaceutical Legislation. Volume 6 - Notice to Applicants. Volume 7 - Guidelines. Volume 8 - Maximum residue limits. Concerning Medicinal Products for Human and Veterinary use: Volume 4 - Good Manufacturing Practices. Volume 9 - Pharmacovigilance. Miscellaneous:
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]
The requirement for QP oversight has been extended to material for use in clinical trials since the introduction of EU Directive 2001/20/EC. In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed responsible person ( RP ) or authorized person ...
New research links omega-6 fatty acids, commonly found in seed oils, and colon cancer growth. But there’s more to the story—and study if you read it carefully.
The European regulatory authorities update the database continuously and expect it to grow extensively over the next few years as more “GMP certificates are imported each year.” [2] The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer.
By Nate Raymond (Reuters) -A U.S. appeals court has halted enforcement of an anti-money laundering law that requires corporate entities to disclose the identities of their real beneficial owners ...
When is the 2025 U.S. Navy All-America Bowl? Here is the time, rosters and TV channel to watch the high school football all-star game: