About this Project
OBJECTIVE
cGMP Program Compliance and Gap Analysis, as well as training clients staff on current good manufacturing practices.
SERVICES
PSC® performed cGMP Program Compliance and Gap Analysis and trained their staff on current good manufacturing practices. The audit also covered US FDA and European Current Good Manufacturing Practices. PSC® recommended improvements and upgrades to quality systems and quality systems operations. In addition, PSC® prepared and advised on Process Validation protocols, quality risk assessment procedures and cGMP compliance programs. Finally, PSC® developed European Pharmacopoeia CEP certification plan.
PROJECT SUCCESS
The project was successful and the client acheived European Union Marketing Authorization. The company is also still a client of PSC®.