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In September 2022, PQE Group was engaged by a Client based in APAC to conduct a mock inspection to evaluate the global level of GMP compliance status of its sterile drug product manufacturing facility, along with its GMP compliance for the product being submitted to the FDA.
Identifying gaps in inspection readiness and different GMP non-conformities, PQE Group supported the Client in enhancing its quality standards and preparing for the FDA Inspection.
Throughout 2023, our dedicated team provided invaluable support, leading to the successful completion of the FDA Inspection in the beginning of 2024 and subsequent FDA approval of the product, officially granted in the spring 2024.
How did we achieve this success?
We created a team of diverse expertise, enabling support across multiple areas including Quality Compliance and Operations, Quality Control, Sterile Manufacturing, Data Integrity, IT, CSV, and Engineering. This team, operating both on-site and remotely, consisted of both local (Asian) and international consultants, all with extensive experience with GMP and FDA Inspections.
Just like a well-coordinated relay race, our team worked seamlessly together, passing the baton of responsibility with each leg of the project journey. Team synergy and agile, proactive support were fundamental elements that drove our success. Our team adeptly responded to client requests, demonstrating a commitment to understanding and accommodating their unique methods and culture. This approach allowed us to build strong partnerships with our client, fostering trust and collaboration.
By leveraging our diverse expertise and collaborative approach, we were able to effectively support the client in improving their knowledge and awareness of quality standards. Our team provided valuable insights and guidance, helping the client navigate the complexities of regulatory requirements and GMP.
As a result of our efforts, our Client successfully obtained FDA approval, a significant milestone that validated their commitment to quality and compliance. This achievement not only boosted their reputation in the industry but also opened new business opportunities by enhancing their position in the US market.
If you want to know more about this successful project, download the Case Study here below!
