cGMP Program Compliance and Gap Analysis

US FDA and European Current Good Manufacturing Practices.

Area: Santa Monica, CA
Project Type: Auditing

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®.

Related Projects

Assessing the Quality Systems and Records

Supplier Audits

Audit Inspection of cGMP Manufacturing Facility

Mock Audit for Manufacturing Facility

field & lab calibrations

Nutritional Supplement Manufacturing Facilities

Provided Audits to meet government regulation standards. 

How Can We Help You?