Van Zyl GMP International Posts - TopicsExpress

MHRA Questions and Answers on Quality Risk Management 1. Do all
MHRA Questions and Answers on Quality Risk Management 1. Do all inspections cover the quality risk management process? Yes, quality risk management (...

Warning letter to American Pharmagen Laboratories, Inc 24 October
Warning letter to American Pharmagen Laboratories, Inc 24 October 2014 Insanitary Conditions Observed During FDA’s Inspections - For more details r...

Hikma Farmaceutica, (Portugal) S.A. Warning letter (October
Hikma Farmaceutica, (Portugal) S.A. Warning letter (October 2014) 1. Your firm failed to thoroughly investigate any unexplained discrepancy or fai...

Yet ANOTHER recall for Hospira Hospira, Inc. (NYSE: HSP),
Yet ANOTHER recall for Hospira Hospira, Inc. (NYSE: HSP), announced it is initiating a voluntary nationwide user-level recall of one lot of Vancomyci...

Time Saddle recommends that Document Style and Layout should be
Time Saddle recommends that Document Style and Layout should be appropriate. It is often helpful to adopt a specific document style for consistency o...

ECA reports on the new GMP requirements for Recalls and
ECA reports on the new GMP requirements for Recalls and Complaints. This summary can be looked and, and help you to start the review of your SOPs for ...

Halol Plant of SUN Pharma may get an Import Alert. The US FDA
Halol Plant of SUN Pharma may get an Import Alert. The US FDA did an inspection at SUN Pharma’s Halol Plant in the last few days. As reported by Bu...

Australia. TGA adopts EU guidelines CPMP/EWP/560/95/Rev. 1
Australia. TGA adopts EU guidelines CPMP/EWP/560/95/Rev. 1 Corr.* (pdf,833kb)* Guideline on the Investigation of Drug Interactions In place of: CPMP/...