GMP Audits

We provide full consultancy from DMF and Dossier preparation to audit on site for USFDA, MHRA, WHO and other semi regulatory audits. We support in prepration of following documents:

• Buildings and Facilities
• Contract Manufacturers (including Laboratories) Quality Management
• Materials Management
• Packaging and Identification Labelling
• Process Equipment
• Personnel
• Production and In-Process Controls
• Rejection and Reuse of Materials
• Starting Materials
• Validation
• Change Control
• Complaints and Recalls
• Documentation and Records
• Laboratory Controls
• Other documents required by different regulatory agencies.