GMP Procedures (SOPs)

Gowning Requirements

Creation of Performance Qualification Protocols

Creation of Operational Qualification Protocols

Creation of Installation Qualification Protocols

Corrective and Preventative Actions (CAPA)

Raw Material Receipt and Disposition

Post Marketing Surveillance / Recalls

QA Hold System

Vendor and Contractor Operation Qualification

Risk Analysis

Third Party Change Control Oversight

Corporate QA Audits