McGuff Pharmaceuticals Inc 12/28/10 Warning Letter CGMP Violations  Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. §211.192] For example, your firm failed to conduct adequate investigations into action level … [Read more...]
FDA’s Guidance for Industry Process Validation Issued Today
JUST RELEASED -- January 24, 2011 Guidance for Industry Process Validation: General Principles and Practices; Current Good Manufacturing Practices (CGMP), Rev 1. January 2011. Please contact: Barry A Friedman, PhD at barryafriedman@aol.com for a copy … [Read more...]
McGuff Pharmaceuticals Inc Warning Letter 12/28/10 API and Endotoxin
McGuff Pharmaceuticals Inc Warning Letter 12/28/10 API and Endotoxin CGMP Violations - Barry A Friedman, PhD LLC 2. Your firm has not conducted at least one specific identity test and has not established the reliability of the supplier’s analyses through appropriate validation of the supplier’s results at appropriate intervals [21 C.F.R. … [Read more...]
McGuff Pharmaceuticals Inc Warning Letter 12/28/10
McGuff Pharmaceuticals Inc 12/28/10 Warning Letter CGMP Violations "Your firm’s qualification of the Getinge Model 4300 autoclave and Grieve CLE-500 oven are inadequate in that you have not qualified this equipment with representative loads. Your firm’s practice is to qualify the equipment using … [Read more...]
Warning Letter – McGuff Pharmaceuticals – Validation of Aseptic and Sterilization Processes
McGuff Pharmaceuticals Inc 12/28/10 Warning Letter CGMP Violations “Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes {21 C.F.R.§211.113(b)}. For … [Read more...]
