Mission, Vision and Values

The PIC/S’ mission is to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products.

Mission

Mission

PIC/S’ mission is to be achieved by:

  • Developing and promoting harmonised GMP standards and guidance documents (see "GMDP Harmonisation" and "Publications");
  • Training Competent Authorities, in particular GMP inspectors (see "Training");
  • Assessing (and re-assessing) GMP Inspectorates (see "Accession" and "Compliance");
  • Facilitating co-operation and networking for Competent Authorities and International Organisations (see "International Co-operation").

Vision and Values

PIC/S’ successful development has been possible due to the common sharing of the following shared vision and principles:

A technical expert’s organisation: PIC/S has always taken great pride in featuring itself as a purely technical organisation in the field of regulatory GMP. Not becoming politically involved or discriminating against e.g. religion or race has always been PIC/S’ firm belief. Moreover, PIC/S is a major “think-tank” in the GMP field, the place where new ideas related to GMP are debated by highly competent experts.

Based on consensus and mutual trust: Consensus in PIC/S has been based on the understanding that all Members have equal rights and obligations and that no Member is more "equal" (larger, richer…) than others. Despite the difficulty of having to negotiate compromises acceptable to all Members, PIC/S has always found a way forward without isolating a Member, which finds itself alone against the vast majority. Mutual trust is a key value in PIC/S and largely relies on the concept of

a) voluntary co-operation (there is no legal obligation under PIC/S) and
b) each Member being assessed for equivalence before being admitted.

As all PIC/S Members are supposed to be equivalent, Members find it easier to exchange information on GMP on a voluntary basis.

Driven by Members: PIC/S is an organisation which is mainly driven by Participating Regulatory Authorities and where the Secretariat has remained flexible and productive. As a result, PIC/S is a flexible and dynamic organisation, which is neither bureaucratic nor expensive. This also implies that Participating Authorities are expected to contribute to either PIC/S events (e.g. by hosting training events) or to PIC/S functioning (e.g. by allowing Members to carry out official duties for PIC/S such as chairing PIC/S meetings or representing PIC/S during conferences).

Cemented by strong professional and personal links: PIC/S’ strength relies on its informal character, networking and the strong personal links between individual Members or Inspectors which have created a forum for brain storming, discussing new ideas and sharing information. It is not a coincidence that the first draft of the ICH Q7A Guide was initiated by PIC/S.