Design

• Quality Systems - design, organize and document quality policy, pharmaceutical quality system and quality objectives
• Protocols - process validation, equipment validation, cleaning validation
• Standard Operating Procedures - manufacturing procedures, metrology, equipment maintenance
• Technology Transfer - transfer of knowledge, technology and life cycle management

Audit

• Pre-Approval Preparation - review operations, data and documentation to insure inspection readiness
• Due Diligence - evaluate quality system and product knowledge base of potential partners or acquisitions
• Supplier Qualification - confirm capabilities of supplier and quality of purchased materials
• Periodic Internal Review - verify quality system is operating as designed

Document

• Management Summaries - quality system performance, issues, projects, and progress
• Annual Product Reviews - compile and assess production volume, deviations, investigations, complaints, release and stability data
• Quality Agreements - negotiate internal and external responsibilities and communication processess for outsourced activities
• Critical Process Controls - identify and control parameters that impact critical quality attributes