GMP / QP Audits

A GMP / QP /Third party audit is a very important regulatory process. Pharmaceutical manufacturers are required to carry out audits of their suppliers or have audits conducted on their behalf by appropriately qualified, experienced auditors.

Repeated on-site audits are mandatory for ensuring GMP and GDP compliance of Key Starting Materials (KSMs), Intermediates, APIs, Excipients and Finished Products. This has been unequivocally clarified in legal regulations such as directive 2011/62/EU.

Simpruv provides auditing services for pharmaceutical manufacturers to meet their audit requirements for regulatory authorities. Simpruv carries out a complete chain of audits which assures product safety and quality to clients across the globe for Key Starting Materials (KSMs), Intermediates, Excipients, APIs and Finished Products.

Simpruv has in-house team of Auditors who are accredited with various certifications including APIC/CEFIC, ASQ, CQA/IRCA.

Simpruv provides personalized, detailed and comprehensive GMP audit reports that are recognized and accepted by QPs and regulatory authorities around the world. The Simpruv list of audit reports is updated regularly. If you would like to receive updates on new reports in the library, please join the Simpruv mailing list.

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