Inspections Co-operation

GMP) controls and inspection, although where appropriate these requirements should be complied with. Manufacture of the finished dosage form should always be GMP compliant. There are also proposals for GMP compliance for active ingredient manufacture, which have been submitted for comment by the Enterprise Directorate General and under the auspices of the Pharmaceutical Inspection Convention-Pharmaceutical Inspection Co-operation Scheme (PIC-PIC/S) and the ICH process. 

Brunner, D. (2004), Pharmaceutical inspection co-operation scheme (PIC/S), Qual.Assur. T, 8,207-211. 

Pharmaceutical inspection co-operation scheme, available http //www.picscheme. org/guides.php. ... 

Recent initiatives by global organizations such as ISO (International Organization for Standardization, www.iso.org) and ICH (International Conference on Harmonization, www.ich.org) are attempting to bring consistency in concept and standardization in definition to the QMS. In 2004, the Pharmaceutical Inspection Co-Operation Scheme (PIC/S, www.picscheme.org) issued its recommendation on Quality System Requirements for Pharmaceutical Inspectorates. The U.S. Food and Drug Administration (FDA) initiated inspection surveillance approaches based upon QMS organization and is another source of definition and interpretation. 

Process validation is not just an FDA or a U.S. requirement. Similar requirements are included in the World Health Organization (WHO), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the European Union (EU) requirements, along with those of Australia, Canada, Japan, and other international authorities. 

Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation, Pharmaceutical Inspection Co-Operation Scheme PIC/S PI 006 (2002). 

Pharmacentical Inspection Co-operation Scheme (2003), Good Practices for Computerised Systems in Regulated GxP Environments, Pharmacentical Inspection Convention, PI 011-1, Geneva, Angnst. 

Pharmaceutical Inspection Co-operation Scheme (2003), Good Practices for Computerised Systems in Regulated GxP Environments, Pharmaceutical Inspection Convention, PI OII-I, Geneva, August. Reid, C. (2001), Effective Validation Strategies, Third Annual Conference on Computer Systems Validation for cGMP Pharmaceuticals, London, March 28 and 29. 

PIC/S (2000), Guide to Good Manufacturing Practice for Medicinal Products, Pharmaceutical Inspection Co-operation Scheme (PlC/S), Document PH 1/97 (Rev.), December. 

Guide to good manufacturing practices for medicinal products. Geneva, Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, 2004. 

Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Scheme. PIC/S Guide to good practices for the preparation of medicinal products in healthcare estabhshments. PE 010-4. http //www.picscheme.org/publication.php p=guides. Accessed 14 July 2014... 

Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Schtane. PIC/S Guide to good practices for the... 

Pharmaceutical Inspection Craivention Pharmaceutical Inspection Co-operation Scheme. Good practices for computerised systems in regulated GxP environments. PI 011-3. 2007, pp 1-54. http // www.picscheme.OTg )ublicati[Pg.768]

Other GMPs that may be relevant for European pharmacists are the US-GMP created by the FDA [18] and the WHO-GMP [19]. The latter may act as a basis for countries that lack own GMP legislation. There is a global harmonisation activity of GMPs through the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme [20]. 

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. htq> //www.picscheme.org... 

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