For API/ Excipient (Raw Material) Manufacturers:
Sourcing of raw materials, packaging materials and active pharmaceutical ingredients from third world countries is common practice, particularly in the production of generics. Normally, certificates of suitability (CEP), ISO or GMP certificates from these third world countries are not considered sufficient proof of compliance with GMP Guidelines for the production of a pharmaceutical product.
In such cases only a Quality System audit for a specific Active Pharmaceutical Ingredient which is performed on-site is accepted by the regulatory authorities as proof of the GMP compliance of the API manufacturer. Such GMP audit must be performed regularly, every two to three years. A GMP audit in the form of a third party audit and audit report provided by contract partners is explicitly permitted as per the different Regulatory authorities.
Mediviz is competent to and undertakes such Third Party Audits on behalf of manufacturers located in India or abroad.
For Analytical Testing Sites/Contract Manufacturing Facilities:
Mediviz identifies suitable API/Formulation contract manufacturing / testing facilities for the execution of clients products by scrutinizing Technical/GMP/Regulatory/Safety aspects based on the client requirement.
Mediviz also identifies analytical testing laboratories by evaluating GMP/GLP compliance for testing of different parameters based on client’s requirement.
The Scope of Third Party Quality Audit Services:
- Raw Materials (API and Excipients)
- Current Good Manufacturing Practices (cGMP)
- Quality Systems audits
- Packaging Material
- Product (Sterile and non- sterile forms)
- Analytical Testing Sites
- GMP Gap Analysis