The United States Food and Drug Administration (FDA) have applied for a membership with the Pharmaceutical Inspection Cooperation Scheme (PIC/S), an international initiative to harmonise GMP standards. This is part of FDA's 21st Century Drug cGMP initiative with global harmonization, said Dr Ludwig Huber, Compliance and Validation expert, Agilent Technologies.
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP.
PIC/S mission is to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products. This is to be achieved by developing and promoting harmonised GMP standards and guidance documents; training competent authorities, in particular inspectors; assessing (and reassessing) inspectorates; and facilitating the co-operation and networking for competent authorities and international organizations, he added.
Currently PIC/S has 29 members with the authority from Poland being the most recent addition in January 2006. Most of the regulatory authority members are from Europe. Non-EU member countries include Switzerland, Canada, Australia, Singapore and Malaysia.
According to Dr Ludwig Huber, PIC/S provides for GMP inspection reports and GMP certificates to be exchanged. However, being a member of PIC/S does not mean that GMP certificates are automatically accepted within all member countries. The big benefit for the industry are more harmonized and thus more predictable inspections which are achieved through good practices guides, inspection guides and a structured training programme.
Harmonized inspections are also achieved through the 'Joint Visits Program'. Within this program inspectors from countries are teamed up to observe typical GMP inspections in each country and deviations from expectations are reported.