Pharmaceutical Inspection Co-Operation Scheme
What is PIC/S?
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was founded in 1995 as an extension to PIC (Pharmaceutical Inspection Convention) which was founded in October 1970 by EFTA (European Free Trade Association) under the title of “The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products”.
PIC/S is a non-binding co-operative arrangement between Regulatory Authorities in the field
of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.
It is open to any authority having a comparable GMP inspection system.
PIC/S comprises more than 50 participating authorities coming from all over the world
(Europe, Africa, America, Asia and Australasia).
This is reflected in PIC/S’ mission which reads as follows: “To lead the international
development, implementation and maintenance of harmonized GMP standards and
quality systems of inspectorates in the field of medicinal products.”
PIC/S GMP in Thailand
On 20 March 2015, Thailand’s Food and Drug Administration (Thai FDA) applied for PIC/S membership. The Rapporteurs will be appointed at the next PIC/S Committee meeting in Geneva (Switzerland) on 11-12 May 2015. Finally, Thailand get officially PIC/S member no. 49 on August 1st, 2016.
PIC/S GMP vs WHO GMP
PIC/S GMP have more than 636 rules. Whereas, WHO GMP have 77 rules. Accordingly, PIC/S GMP ensures that all members comply with PIC/S standards have high quality of product and greater confidence.
Ref : www.picsheme.org
