Pharmaceutical Technical Procedures
Found 5 free book(s)
The Globalisation of the Pharmaceutical Industry
www.ifpma.orgfor Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities and pharmaceutical industry repre-sentatives to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global
Q8 (R2) Step 5 Pharmaceutical Development
www.ema.europa.euThis guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The Pharmaceutical Development section provides an opportunity to …
Temperature mapping of storage areas - WHO
www.who.intTechnical Supplement: Temperature mapping of storage areas 6 1. Introduction This technical supplement has been written to amplify the recommendations given in Section 4.7 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products 6. The
Quality Agreement for Laboratories Guideline Templates
apic.cefic.orgof safe materials (APIs or intermediates) acceptable for pharmaceutical use. A Quality Agreement is based on the quality procedures in place at both the service requestor and the service providing laboratory. The Quality Agreement also includes commitments between
Klucel hydroxypropylcellulose - Ashland
www.ashland.comHPC, specific for pharmaceutical applications, as developed in our research and plant facilities. Also included is information about the behavior of Klucel HPC in a number of common pharmaceutical applications. A guide to regulatory status and toxicological studies is provided for convenient reference. The Appendix gives information about the