The Pre-Accession Procedure is a voluntary assessment step to the Accession Procedure. Its purpose is to allow interested Competent Authorities willing to become PIC/S Participating Authorities (PA) to better understand what PIC/S is and what the expectations are for becoming a PA.

The Pre-Accession Procedure is recommended if your Inspectorate:

  • is unsure as to whether or not it meets PIC/S requirements; and/or
  • has not introduced an inspectorate quality system as per the PIC/S recommendation (PI 002); and/or
  • does not apply the PIC/S GMP Guide or equivalent guide;
  • has not regularly participated in PIC/S training activities.

The Pre-Accession Procedure serves to identify the necessary elements of the GMP Regulatory Compliance Programme as defined in the Audit Checklist (PS/W 1/2005) to be provided by the interested Competent Authority to help it understand the gaps between PIC/S requirements and its GMP Regulatory Compliance Programme within its own territory and abroad. The Pre-Accession Procedure is not a form of consultancy and there will be no follow-up within the Pre-Accession Procedure of the corrective actions to overcome the identified gaps.

Please note that the maximum timeframe for the pre-accession process is 2 years upon receipt of the completed Audit Checklist and Questionnaire (see below "Related Documents").

The Pre-Accession Procedure is described in detail in the PIC/S Guidelines for the Pre-Accession Procedure (see below "Related Documents").

Related documents

Document Reference date
pic/s guidelines for the pre-accession procedure PS W 12 2019 (Rev. 1) 2022
pic/s guidelines for accession PS W 14 2011 (Rev. 3) 2022
questionnaire for assessment PS W 01 2011 (Rev. 1) 2022
pic/s audit checklist PS W 01 2005 (Rev. 3) 2022
pic/s audit checklist - interpretation guide PS W 31 2019 2020