(2002; 166 pages)
Value of joining the Pharmaceutical Inspection Cooperation Scheme (PIC/S) for developing countries: the Malaysian experience
Mr Mohammed Zin Che Awang, Malaysia
The PIC/S was implemented in 1995. Its objectives are to facilitate networking and confidence-building, to promote the quality of inspections and quality assurance of inspectorates, to coordinate training of inspectors, to provide a framework for the exchange of information and experience in GMP, and to enhance global harmonization of GMP.
Malaysia applied to join the PIC/S in February 2000. After assessment of the Malaysian documents on the regulatory system, an assessment visit by a PIC/S team was made in March 2001 and a reassessment visit in November 2001. Malaysia was accepted as the 26th member in January 2002.
There is a need to harmonize GMP inspection standards through the training of inspectors in developing countries to ascertain the quality of starting materials and manufactured pharmaceutical products and the PIC/s provides a platform for activities in this area.