GMP Procedures (SOPs)

Corporate QA Audits

Third Party Change Control Oversight

Risk Analysis

Vendor and Contractor Operation Qualification

QA Hold System

Post Marketing Surveillance / Recalls

Raw Material Receipt and Disposition

Corrective and Preventative Actions (CAPA)

Creation of Installation Qualification Protocols

Creation of Operational Qualification Protocols

Creation of Performance Qualification Protocols

Gowning Requirements