March 2006 - PIC/S Blueprint

by Robert M. Tribe

Background
On 23 December 2005, PIC/S published its “Blueprint” which is essentially a roadmap for the next decade, providing a prospective and retrospective review of PIC/S’ mandate and goals. The Executive Summary of the PIC/S Blueprint is reproduced below. More extensive detail on the Blueprint can be obtained from the PIC/S web site at www.picscheme.org

Blueprint – Executive Summary
PIC/S has been a pioneer organization in the field of pharmaceutical inspections and Good Manufacturing Practice (GMP). It has successfully adapted to a constantly changing environment, notably increased European integration and globalization. Its membership has grown from 10 to 28 Participating Authorities today . Most of its Members are Authorities of Member States of the European Union (EU).

It has become vital for PIC/S to distinguish itself, in a constructive way and in a spirit of complementarity, in its activities from other bodies and organizations, in particular the European Medicines Agency (EMEA) or the EU Heads of Agencies. PIC/S must increasingly focus on its added-value and specificity. In a world which has become increasingly globalized, PIC/S must turn more global as well and reach out to the world.

In order to achieve this and simultaneously improve its position as a “global player” at the international level, PIC/S must become more representative and expand to America, Asia and Africa. It must in particular actively encourage non-EU Members to join PIC/S, notably “key players” such as the US FDA, Brazil, Japan, etc. However, integrating these key players should not result in either a lowering of standards or a reduction in PIC/S activities.

As its membership will grow by 10 – 12 new Members by 2015, PIC/S will have to review its organization and functioning while ensuring that existing and new Members adhere to the existing values and principles. While expanding, the organization should remain an egalitarian one which is not dominated by one particular bloc or another. In maintaining this equality, it must draw on the best from the different strands of membership and also be cognizant of developments amongst those who remain outside.

PIC/S’ mission, as defined in 2002, still remains valid today, i.e.: “To lead the international development, implementation and maintenance of harmonized GMP standards and quality systems of inspectorates in the field of medicinal products.” This is to be achieved by developing and promoting harmonized GMP standards and guidance documents; training competent authorities, in particular inspectors; assessing (and reassessing) inspectorates; and facilitating the co-operation and networking for competent authorities and international organizations.

In the field of standards, PIC/S will continue to harmonize and modernize its GMP standards and ensure that the PIC/S GMP Guide remains a high-standard international GMP Guide. Other guidance documents will be developed according to established priorities. The extension of PIC/S’ mission to include Good Distribution Practice (GDP) standards will be considered.

The various training and harmonization tools (Seminar, Expert Circles, Joint Visits Programme), which have proved to be effective so far, will be “professionalized” and opened up to include Member-specific training needs. The number of Expert Circles will be increased. Coached inspections for training purposes will be introduced. Training will increasingly focus on improving consistency and uniformity of inspections amongst PIC/S Participating Authorities – an area where Inspectors are sometimes criticized by industry.

The assessment of new Members and the reassessment of existing Members will have to be further harmonized so that the same tools can be used in the future.

PIC/S will more actively encourage networking by establishing on a regular basis a “PIC/S GMP Forum” which will allow non-Member Authorities, professional and other organizations to meet informally with the PIC/S Committee .

The increasing globalization of public health concerns and the multiplication of actors involved (both in industry and among Regulatory Authorities) makes it necessary to further increase harmonization efforts in setting regulatory requirements, inspecting and evaluating GMP compliance, licensing manufacturing sites, recalling defective batches, and increasing the exchange of information. PIC/S offers an attractive platform to respond to the challenges of globalization.

The sharing of information on GMP inspections will be further encouraged in order to maximize the use of resources. Regarding overseas inspections, other means than the International Medicinal Inspectorates’ Database (IMID) will be used to avoid duplications with the EUDRA GMP Database.

Relations with other organizations will be reviewed on the basis of (i) non-discrimination and equal treatment and (ii) non-duplication with Member Authorities. As human and financial resources are getting scarce at the level of national authorities as well as at the level of international organizations, the duplication of tasks must be avoided. The review should also aim at ensuring the support of relevant professional and other organizations to PIC/S’ mission.

The PIC/S Secretariat will continue to provide professional secretariat services. Available funds will be spent in a conservative and transparent manner to all Participating Authorities in order to keep membership fees stable until 2015.