Guides to good manufacturing practice

Anti-arrhythmic agents Anti-bacterial agents Anti-coagulants Anti-depressants 

Anti-diabetic agents Anti-epileptics Anti-fungal agents Anti-gout agents Anti-hypertensive agents 

Anti-malarials Anti-migraine agents Anti-muscarinic agents 

Anti-neoplastic agents and immunosuppressants Anti-protozoal agents Anti-thyroid agents 

Thyroid agents Vaccines, immunoglobulins and antisera Vasodilators Xanthines 

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Office for Official Publications of the European Community (1992) The Rules Governing Medicinal Products in the European Community, vol. IV, Guide to Good Manufacturing Practice for the Manufacture of Medicinal Products. 

PIC, 1992, Guide to Good Manufacturing Practice for Pharmaceutical Products (Document PH 5/92). 

ENTR/6270/00 Proposal for an Annex 17 to the EU Guide to Good Manufacturing Practice Parametric release (released for comment April 2000)... 

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. 

Table 3.5. Specifications laid down (in the EC Guide to Good Manufacturing Practice for Medicinal Products) for class A, B, C and D clean rooms, as used in the pharmaceutical industry...

Anonymous (2006), Guide to good manufacturing practice for medicinal products, PE... 

Chaloner-Larsson, G, Anderson, R., and Egan, A. A WHO Guide to Good Manufacturing Practice (GMP) Requirements, 1997, World Health Organization, Geneva. 

PIC (1989) Guide to Good Manufacturing Practices of Pharmaceutical Products, PIC-Doc PH 5/89 (now PH 1/97 (rev. 2) [7]) Validation of critical processes, significant amendments to manufacturing processes, significant amendments to manufacturing processes, and of all sterilization processes and test methods stipulated. 

Guide to Good Manufacturing Practice of Medicinal Products. PH 1/97 (Rev. 2). Geneva PIC/S Secretariat (2001). 

EC (2001), Guide to Good Manufacturing Practice Qualification and Validation, Annex 15, Brussels. Available at http //europs.eu.int/comm/enterprise/ pharmaceuticals/eudralex/vol-4/pdfs-en/v4anl5.pdf (accessed October 2006). 

Good documentation constitutes an essential part of the quality assurance system. As claimed in the European Community (EC) Guide to Good Manufacturing Practice (GMP), Chapter 4 Clearly written documentation prevents errors from spoken communications and permits tracing of batch history. In general, the requirements for documentation related to manufacturing of pharmaceuticals, as set in the GMP... 

European Commision (2003), EU Guide to Good Manufacturing Practice, Annex 1 and 3, Brussels, Belgium, October 8. 

PIC (1992), Guide to Good Manufacturing Practice for Pharmaceutical Products, Convention for the Mutual Recognition of Inspection in Respect of the Manufacture of Pharmaceutical Products (PIC), Document PH 5/92, Pharmaceutical Inspection Convention. 

The use of computerized systems in the GMP environment in Europe is mainly driven by Annex 11 to the Guide to Good Manufacturing Practices. As Annex 11... 

EU Guide to Good Manufacturing Practice, Draft revised version of Annexl5 Vahdation master plan Design qualification, instaUation and operational quahfication, non-sterile process vahdation, cleaning vahdation. 

European Union Guide to Good Manufacturing Practice Annex 1 on the Manufacture of Sterile Medicinal Products European Commission, 1996.. 

European guide to good manufacturing practice, 1997, annex 12. In The Use of Ionising Radiation in the Manufacture of Medicinal Products Brussels, 1997. 

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