AUDITS

With over ten years of experience, divinegrp is a trusted leader in conducting comprehensive third-party GMP audits across India, China, and Malaysia. Our proven track record ensures that your manufacturing processes meet stringent international quality standards and regulatory requirements.

Our Audit Services Include:

• API Manufacturing Audits: Conducted by Article 46 b(2)(b) of Directive 2001/83/EC, as amended by Directive 2011/62/EU. Our audits ensure that Active Pharmaceutical Ingredients (APIs) are produced under rigorous quality controls and compliant with EU regulatory expectations.

• Finished Formulation Audits: Performed following VOL 4 – Part 1 of the EU GMP guidelines, our audits for finished formulations help verify that your products are manufactured in a controlled environment, ensuring safety, efficacy, and quality for end users.