SeerPharma has been engaged by multiple companies to conduct GMP audits in the Asia-Pacific region on behalf of Qualified Persons (QP) in Europe.
Organisations have turned to SeerPharma for assistance in providing independent assessments of their Quality Management Systems and manufacturing operations to satisfy the specific needs of QPs.
Inspections by SeerPharma have been conducted to assist:
- Firms looking to enter the EU Market
- Routine surveillance audits requested by QPs for products already marketed in the EU.
These audits are conducted against Eurdalex Volume 4 (EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use), helping ensure QPs meet their regulatory obligations as specified in Annex 16.The final detailed audit report requested by QPs include a description of:
- The audited products
- The audited operating units/departments
- The functional capability of the QA Systems
- The relevant manufacturing and testing processes/steps
- Compliance with the Marketing Authorisation
- Compliance with manufacturing standards and requirements defined in the relevant parts and annexes of the PIC/S Guide to GMP.
Contact us to leverage our services in conducting independent GMP audits on behalf of Qualified Persons in Europe.