Search results
Results from the WOW.Com Content Network
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the ...
This guideline is intended to summarise the available literature, the advice provided by existing national guidelines and the information from current national practice on the choice of comparator, and to outline some of the challenges arising when establishing what the comparator for a specific assessment should be.
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: Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
Bulk pharmaceuticals can be shipped to another pharmaceutical company for further processing, to a contract packager for forming unit packs, to international customers, etc. Bulk shipments might be in fiber drums (with plastic liners), bulk boxes, corrugated boxes with liners, intermediate bulk containers, and other shipping containers.