Pharmaceutical Inspection Cooperation Scheme

ICH guidelines are divided into four major categories. 

M2—Electronic Standards for Transmission of Regulatory Information (ESTRI) 

M3—Timing of PrecUnical Studies in Relation to Clinical Studies 

The WHQ works with regulatory authorities in member states to set up policies and training programs to ensure drugs are safe, pure, and effective and are being distributed and administered as specified. 

Diagrammatic Representation of the Organization of the ICH CTD Common Technical Document 

Definition of a medicai device Risk-based classification of devices Essential principles of safety and performance Labelling 

The role of standards Clinical evaluations Summary technical files 

Quality systems for design and manufacture Process validation Design control process 

France Netherlands Slovac Republic Czech Republic 

The present list of PIC/S participating authorities may have been updated. For the latest up-to-date list, see www.picscheme.org. 

Center for Biologies Evaluation and Research, CBER s Report to the Biologies Community—2000, FDA, Rockville, MD, 2000, http //ww.fda.gov/ 

European Agency for the Evaluation of Medicinal Products website, 

European Commission Enterprise Directorate-General, Pharmaceuticals in the European Union, Office for Official Publications of the European Communities, Luxembourg, 2000. 

Food and Drug Administration, Activities of FDA s Medical Product Centers in 2001, FDA, Rockville, MD, 2001, http //www.fda.gov/bbs/topics/ ANSWERS/2002/ANS01132.html [accessed Apr 1, 2002], 

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The Pharmaceutical Inspection Cooperation Scheme (PICS) was established in 1995. It brings together regulatory authorities from different countries, for the purpose of developing harmonised GMP requirements and inspection techniques, with the goal... 

Table 2.2 Participants of the Pharmaceutical Inspection Cooperation Scheme (PICS) by country.

There are two relevant proposals at the time of writing CPMP/QWP/3015/99 draft (released for comment March 2000) and ENTR/6270/00 proposal (released for comment April 2000) from the Inspectors Group and the Pharmaceutical Inspection Convention-Pharmaceutical Inspection Cooperation Scheme (PIC-PIC/S). 

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) was formed in 1995 to enhance the work set up under the Pharmaceutical Inspection Convention (PIC) in 1970. The mission of the PIC/S is... 

Pharmaceutical Inspection Cooperation Scheme website, http //www.picscheme.org/ index.php. 

In Europe, inspections are conducted by member states on behalf of the European Union. For drugs approved under the centralized procedure, inspections are coordinated by the European Medicines Agency (EMEA refer to Sections 7.3 and 8.3). For countries that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S see Section 7.13), there is mutual recognition of inspections performed by members. 

Manufacturing sites within Australia must comply with the Australian Code of GMP for Medicinal Products - August 2002, which is based entirely on the international standard Guide to Good Manufacturing Practices for Medicinal Products, Version PHl/97 (Rev.3) 15 January 2002, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The ICH GMP Guide for Active Pharmaceutical Ingredients has also been adopted. 

World Health Organization Pharmaceutical Inspection Cooperation Scheme International Conference on Harmonization Association of Southeast Asian Nations (ASEAN) Mercado Comun del Sur (MERCOSUR)... 

European Union Pharmaceutical Inspection Cooperation Scheme... 

Recommendations on cleaning validation. Document PR 1/ 99-2. Pharmaceutical Inspection Cooperation Scheme Geneva, Switzerland, 1 April, 2000. 

The Committee was informed by the European Medicines Agency (EMEA) of a proposed approach to facilitate inspections and to avoid duplication of inspections. A GMP database was being established in the European Union by Member States that would provide information on and outcome of inspections. The database was expected to be released in 2006. Access rights were being discussed with WHO, the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the European Directorate for the Quality of Medicines (EDQM) and other organizations. Different levels of access will exist including one for public access and others for national medicine regulatory authorities, WHO and PIC/S. 

We discussed in Section 7.8 the tripartite harmonization of common technical documents (CTDs) by the US, Europe and Japan. The GMP Guidance is one of these CTDs it is described in the ICH Q7A document called GMP Guidance for Active Pharmaceutical Ingredients. Because of the wide implications of this guide, the Steering Committee of ICH invited experts from Australia, India and China and industrial representatives from the generics industry, self-medication industry and PIC/S (Pharmaceutical Inspection Cooperation Scheme, Section 7.10) to participate in Jihe preparation of this document. Hence, the Q7A document has been endorsed as a truly international document for GMP. 

Pharmaceutical Inspection Cooperation Scheme (PIC Scheme), which has been operating since 1995, was formed as an extension of PIC, offering a more flexible cooperation between PIC and health authorities outside Europe. 

Inspection of Computer Systems. Presentation at Pharmaceutical Inspection Cooperation Scheme Seminar, 18-20 September 1996 in Sydney, Australia. 

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