cGMP AUDIT

FDA (Food and Drug Administration) strongly enforces cGMP (current Good Manufacturing Practices) regulation that ensures Pharmaceutical Quality assuring proper design, monitoring and control of manufacturing processes and facilities.

Pharmaceutical Quality is the keystone allowing patients and medical professionals to have confidence in the safety and effectiveness of the medications whereas cGMP auditing is a crucial regulatory process improving trust insights on the manufacturer.
Muthra Global performs impartial cGMP auditing services for pharmaceutical manufacturer in order to meet their regulatory requirements based on norms of EudraLex ICH Q10 specified by FDA.

We audit broad categories of pharmaceutical product life cycle of a Small/Medium/Large manufacturing industry:
1. Intermediates and API: To evaluate establishment’s compliance with GMP requirements, particularly regarding environment, quality management, personnel, facilities and equipment, Laboratory control, and Packaging and labelling.
2. Formulation (sterile and non-sterile): To evaluate establishment’s compliance with GMP requirements, we approach a Six-System Inspection Model which can help to evaluate the pharmaceutical manufacturers comply with cGMP regulations. The six systems referred to in this inspection model are: quality, production, facilities and equipment, laboratory controls, materials, and packaging and labelling.
3. Excipients: To evaluate procedures and controls implemented in the manufacturing of excipients, to determine whether they are in conformity with the application commitments.
4. Packaging material manufacturing site: By inspecting the packaging measures with respect to tracking and tracing of Batch and Lot, Tamper evident measures, patient compliance and product protection as well as ease of transportation.
5. Suppliers and Distributors: By ensuring Quality, secure and efficient delivery of medicines and ensuring distributors sustain the complex supply chain as per GDP guideline.
6. Testing Laboratory: By reviewing laboratory data, procedures and methods, validation data, laboratory equipment including maintenance and calibration to determine the overall quality of the laboratory operation.
7. Warehouse facility: By assessing warehouse ensuring for its essential storage conditions including temperature-controlled and humidity-controlled space as well as contamination free zone.