GMP AUDIT
We offer third-party audits for new and existing manufacturing facilities to ensure high-quality standards that comply with GMP norms and are acceptable to regulatory authorities. Our services include:
- Preparation, Initiation, and Management of GMP Audits from Health Authorities: We handle the entire process, from initial preparation to final management, ensuring seamless and thorough audits.
- Third-Party/Supplier Audits, EU QP Audits, and Mock Audits: We conduct comprehensive audits of third parties and suppliers, including Qualified Person (QP) audits as per EU regulations, as well as mock audits to prepare for actual inspections.
- Assistance in Preparing Site Master Files, Standard Operating Procedures, and Investigation Reports for Deviations: We help you compile essential documentation and reports to maintain compliance and address any deviations effectively.
- Response Preparation for GMP Deficiency Reports: We assist in crafting detailed and compliant responses to address any deficiencies identified during GMP audits.
Our comprehensive services ensure that your manufacturing operations meet the highest quality standards and regulatory requirements.
