GMP Audits

RS Serve offers GMP compliance services including:



• Quality Management System implementation and gap analysis
• Good Manufacturing Practice reviews
• Quality audits of manufactures, suppliers, distributors and contractors of both sterile and non­-sterile APIs and Finished Drug Products
• Process validation, analytical validation and equipment qualification support
• Quality Assurance and Quality Control operational support
• Regulatory inspection readiness preparations
• Documentation design, generation and maintenance support
• Quality Risk Assessment and mitigation support
• Training of staff in areas of Pharmaceutical manufacturing both aseptic and non-aseptic
• Clinical manufacturing and packaging.

 

Other services include:

• GCP auditing and consultancy
• Management of Bioavailability/Bioequivalence (BA/BE) studies
• Validation and Compliance Services for Computer/Lab Systems
• Training/Mock Inspection/SOP development and Management