Implementing FDA, EMA and PIC/S GMP

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.