We have extensive experience working with clients, large and small, to establish or enhance existing GMPs.
We will build a GMP framework that is customized to your unique needs, addressing the key areas identified by MoCRA:
- Documentation – How products are manufactured and tested, defines processes, prevents errors of interpretation or loss of information, and traces problems and how to take appropriate corrective action.
- Records – Records should capture all details of operations, procedures, deviations, justifications, instructions, training, specifications, protocols, reports, methods, precautions, corrections, and others. Raw material records may include information on origin, receipt, examination, testing, disposition, and use records of raw materials. Batch production records and disposition records must also be maintained.
- Buildings and Facilities – Buildings and facilities used for manufacturing are of suitable size, design, and construction, and maintained in a clean and orderly manner. Sufficient space to prevent selection errors. Specific topics include pest control, cleanable surfaces, lighting and ventilation, sanitary operations and prevention of contamination.
- Equipment – Equipment and utensils used in processing, holding, transferring, and packaging are maintained, calibrated, cleaned, sanitized, and stored properly. They are constructed to facilitate adjustment, cleaning, and maintenance and of suitable size and accuracy.
- Personnel – Personnel cleanliness and protective apparel. Visitor policy and authorized personnel access.
- Raw Materials and Packaging Materials – Stored and handled to prevent mistakes, contamination, and degradation. Labeled with identity, lot number and control status. Sampled and tested for conformance with specifications.
- Production – Written manufacturing and control SOPs have been established for formulations, processing instructions, in-process control methods, packaging instructions, instructions for operating equipment, etc.
- Laboratory Controls – Sample collection techniques, specifications, test methods, laboratory equipment, technician qualifications.
- Internal Audit – Effective procedures for internal audits, occurring regularly or on demand.
- Complaints, Adverse Events, and Recalls – Policies and procedures are written and followed to address these important factors.
