The Pre-Accession Procedure is a voluntary assessment step to the Accession Procedure. Its advantage is to offer a gap-analysis thereby providing a safe option for Competent Authorities which may not be able to meet immediately all PIC/S requirements for the Accession Procedure.

The Pre-Accession Procedure should be followed if your Inspectorate:

  •  does not apply the PIC/S GMP Guide; and/or
  •  has not regularly participated in PIC/S training activities; and/or
  •  is unsure whether it meets PIC/S requirements; and/or
  •  has not yet introduced a Quality System (QS) similar along the lines of the PIC/S recommendation (PI 002); and/or
  •  has requested to go through the Pre-Accession Procedure.

Based on the gap-analysis, the PIC/S Committee then decides on whether e.g. to:

  • invite your Authority to apply for membership;
  • to first comply with PIC/S requirements before applying;
  • to conclude a partnership agreement.

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 serves to identify the gaps between PIC/S membership requirements and the system used by the interested Competent Authority. 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.

The Pre-Accession Procedure is described in detail in the Accession Guideline (see below "Related Documents").

Related documents

Document Reference date
pic/s audit checklist - interpretation guide PS W 31 2019 2020
pic/s guidelines for the pre-accession procedure PS W 12 2019 2020
pic/s guidelines for accession PS W 14 2011 (Rev. 2) 2019
pic/s audit checklist PS W 01 2005 (Rev 2) 2014
questionnaire for assessment PS W 01 2011 2011