Guidelines for The Pre-Accession Procedure to Join PIC/S
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has introduced new guideline to The Pre-Accession Procedure to Join PIC/S for competent authorities who interested to join the inspection program.
The Pre-Accession Procedure is also a means of ensuring – through official inspections – that the quality of medicinal products is strictly in compliance with the marketing authorisation and GMP standards.
“PIC/S is open for participation by Competent Authorities having the arrangements necessary to apply an inspection system comparable to that enforced by Participating Authorities and whose requirements and procedures could ensure the proper implementation of PIC/S and contribute to its effective operation.”
The purpose of the pre-accession procedure to allow interested Competent Authorities willing to become PIC/S Participating Authorities to better understand what PIC/S is and what the expectations are for becoming a Participating Authorities.
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.
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.
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