USA – New Guidance Explains How Regulators Can Begin the Process to Join PIC/S

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week released a new guideline explaining its pre-accession procedure for competent authorities wishing to join the inspection scheme.

Membership in PIC/S is open to any competent authority “having the arrangements necessary to apply an inspection system comparable to that enforced by” existing members.

“The scheme is primarily based on mutual confidence between participating authorities (PA). Such confidence can only be achieved on the basis of a thorough knowledge of each other’s inspection systems and inspection practice and standards,” PIC/S writes.

In light of varying good manufacturing practice (GMP) regulations and quality systems (QS) applied by regulators, PIC/S has opted to split its initiation process into two phases: pre-accession and accession.

PIC/S says the purpose of the pre-accession procedure is to allow interested regulators “to better understand what PIC/S is and what the expectations are for becoming a PA.”…