cGMP Compliance Consulting
The cGMP compliance consulting will be conducted in accordance with 21 CFR Part 210 / 211 and Schedule M. We will support our clients in all angles for the successful completion of inspection and audit.
Our consultants will develop, implement, monitor, and audit all processes and control measures carried out in the organization. We can also review the activities silently on your behalf by reviewing your documents at your site and generating a report for you.
Additionally, we can handle related activities for GMP quality audits of your contract fabricators, packagers/labelers, testing laboratories, importers, distributors, or wholesalers.
All our auditors and Consultants are Graduates/Post Graduates in Pharmacy/ Microbiology /Engineers and also ASQ certified, to perform consultancy and audits to assess/implement GMP (Good Manufacturing Practices.
Scope of GMP consulting in detail
- GMP Compliance Audit on Quality System as per Schedule M & QSR
- General GMP audit
- Audit on contractors
- Manufacturing Facility
- Facility Audit
- Inspection of Room book
- Validation System
- Master validation plan
- Design and review validation protocols
- Review validation results and reports
- Documentation System
- Master record
- Control of documents
- Batch record
- Documentation System
- Master record
- Control of documents
- Batch record
- Quality Control System
- In-process material control tests
- Product final release tests
- Validation of analytical methods
- Production and Process Control System
- Process validation
- Environment monitoring
- Calibration and maintenance
- Records and SOP’s
- Quality Assurance System
- Change control
- Product annual review
- Owner training
- Batch record review
- Deviation and investigations
- OOS and investigations
- Material Control System
- Vendor evaluation and control
- Material incoming, storage, and dispatching
Related services
- Mock schedule M and CFR 210/211audit
- Response to FDA 483s
- Response to FDA Warning Letters