Implementing FDA, EMA and PIC/S GMP

September 22, 2016
by SeerPharma

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.

Click here to see all SeerPharma Journal content

Filed Under: FDA, GMP, Audit, PIC/S, HSA, EMA