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.”
Specifically, PIC/S says regulators should follow the pre-accession procedure if they are unsure whether they currently meet PIC/S requirements; if they do not have an inspectorate quality system in line with PIC/S recommendations; if they do not have equivalent GMP standards; or have not regularly participated in PIC/S training activities.
According to the guideline, regulators must be able to attend at least one PIC/S Committee meeting and seminar while their pre-accession application is under review. PIC/S also clarifies that the pre-accession procedure is meant to help regulators “understand the gaps between PIC/S requirements” and their own GMP compliance programs and is not meant to be a consultation with follow-ups on addressing those gaps.
To begin the pre-accession procedure, applicants are instructed to email the PIC/S secretariat, who in turn will provide the applicant with information about the process, timeframe and fees. The applicant will then have to complete a questionnaire and audit checklist and return it to the secretariat.
Once a completed application has been submitted, the PIC/S Committee will select a rapporteur to lead the pre-accession process, which PIC/S says normally takes two years.
The rapporteur is responsible for drafting a timetable for milestones during the procedure; verify that the applicant understands the requirements for PIC/S membership; review the documentation submitted by the applicant; determine if a gap analysis is needed; and provide a short high-level report to the PIC/S Committee on whether the applicant is ready to apply for accession.
During the pre-accession process, applicants are invited to attend PIC/S seminars and participate in PIC/S Committee meetings as observers.
PIC/S