SeerPharma (Singapore) was engaged by a company in Singapore to help implement cGMP for a new clinical trial packaging facility and obtain international certification of conformance to FDA, EMA and PIC/S GMP.
The scope of the work performed by SeerPharma included:
- The preparation of a Site Master File
- Implementation of a Quality Management System (QMS)
- Creation of site procedures
- Pre-audit support before the Health Sciences Authority (HSA) of Singapore’s GMP audit
- Attending HSA’s audit with client
- Follow-up refresher training for their employees
The HSA’s audit was a success as there were no findings (non-conformities) found.
Contact us to explore how we can support your implementation and compliance with international GMPs.
This post comes from our October 2015 Journal.
