Pharmaceutical products
Found 8 free book(s)
ISSN: 2231 Stability Testing of Pharmaceutical Products
japsonline.comJournal of Applied Pharmaceutical Science 02 (03); 2012: 129-138 Stability testing is termed as a complex process because of involvement of a variety of factors influencing the stability of a
GOOD DISTRIBUTION PRACTICES (GDP) FOR …
www.who.intWorking document QAS/04.068/Rev.2 page 4 storage and distribution of such products. In some cases, however, a person or entity involved in the distribution of pharmaceutical products is only involved in and is responsible for certain
Guidelines for good clinical practice (GCP) for trials on ...
apps.who.intINTRODUCTION The purpose of these WHO Guidelines for Good Clinical Practice (GCP) for trials on pharmaceutical products is to set globally applicable standards for the conduct of such
Annex 2 Stability testing of active pharmaceutical ...
apps.who.int89 2. Guidelines 2.1 Active pharmaceutical ingredient 2.1.1 General Information on the stability of the API is an integral part of the systematic approach to stability evaluation. Potential attributes to be …
Annexure-1 GMP CHECKLIST
cdsco.nic.inSOP No.: EP-INS-004 Page 1 Annexure-1 GMP CHECKLIST (Based on WHO Good Manufacturing Practices (GMP) for active pharmaceutical ingredients stated as per
ICH HARMONISED TRIPARTITE GUIDELINE
www.ich.orgPHARMACEUTICAL QUALITY SYSTEM ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 4 June 2008, this guideline is recommended for adoption to the three regulatory parties to ICH
Final Concept Paper Q12: Technical and Regulatory ...
www.ich.orgFINAL Q12 Concept Paper Endorsed: 9 September 2014 -3- product lifecycle management. To date, the main emphasis has been on the implementation of
Annex 3 WHO good manufacturing practices for ...
www.who.int96 Introduction The fi rst WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth