GUIDE TO GOOD MANUFACTURING PRACTICE
FOR MEDICINES IN SOUTH AFRICA
This document has been prepared to serve as a guidance document on the requirements for Good Manufacturing Practice applicable to the manufacturing of medicines. It is not intended as an exclusive approach. Council reserves the right to request for any additional information to establish the safety, quality and efficacy of a medicine and may make amendments in keeping with the knowledge which is current at the time of consideration of data accompanying applications for registration of medicines. Alternative approaches may be used but these must be scientifically and technically justified. The MCC is committed to ensure that all medicines gaining market approval will be of the required quality, safety and efficacy.
This Guide is based entirely on the “Guide to Good Manufacturing Practice for Medicinal Products”, version PE 009-2 dated 1 July 2004 published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The modifications to that Guide and its adoption as the South African Guide to Good Manufacturing Practice is done so with the expressed permission of the PIC/S.
Version 1 - Implementation
Version 1 - Chapter 9 (Validation) reformatted
Version 2 - Sept 2005 adopted PIC/S GMP Guide of July 2004 - Implementation
Version 3 - Sept 2008 update to amend Introduction and include requirements for Quality Product Review (1.5) , Risk Management (1.6), On-going stability programme (6.7), Analytical Method Validation (Annex 15 15.7) and Glossary, keeping of Reference and Retention samples (Annex 19), Quality Risk Management (Annex 20)
Version 4 - March 2009 update to amend Radiopharmaceuticals (Annex 3), Herbal Medicinal Products (Annex 7)
Due date for comment Version 3
31 January 2009
Due date for comment Version 4
30 June 2009
Version 5 (consolidates comments on versions 3 and 4) - Implementation
1 November 2010
REGISTRAR OF MEDICINES
MS M HELA
TABLE OF CONTENTS
CHAPTER 1 - QUALITY MANAGEMENT
Good Manufacturing Practice for Medicinal products (GMP)
Quality Risk Management as Part of Regulatory Operations
Quality Risk Management as Part of Development
Quality Risk Management for Facilities, Equipment and Utilities
Quality Risk Management as Part of Materials Management
Quality Risk Management as Part of Production
Quality Risk Management as Part of Laboratory Control and Stability Studies
Quality Risk Management as Part of Packaging and Labelling
* The ICH GMP Guide on APIs has been provisionally adopted by the European Commission as Annex 18 to the EC GMP Guide while the same document has been adopted as a stand-alone document by the PIC/S Committee (PE 007).
In order to further facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products the following Guide to Good Manufacturing Practice for Medicinal Products and its Annexes has been adopted.
The standards set out herein, apply to medicines and similar products intended for human use. It is recommended, however, that the same kind of attention be given to the manufacture of veterinary products. Administrative measures of national health authorities should be directed towards the application of these standards in practice, and any new or amended national regulations for good manufacturing practice should at least meet their level. These standards are also intended to serve manufacturers as a basis for the elaboration of specific rules adapted to their individual needs.
These standards are also intended to serve manufacturers as a basis for the elaboration of specific rules adapted to their individual needs.
In addition to the general matters of Good Manufacturing Practice outlined in the chapters of this guide, supplementary guidelines such as the Technical Series of the World Health Organisation can be used to clarify and support specific areas of activity.
The standards set out herein, apply to medicines and similar products intended for human and veterinary use.
It is recognised that there are acceptable methods, other than those described in this Guide, which are capable of achieving the principles of the Guide. This Guide is not intended to place any restraint upon the development of new concepts or new technologies, which have been validated and provide a level of Quality Assurance at least equivalent to those set out in this Guide.
The Guide is divided into two parts and a number of annexes, which are common to both parts. Part I covers GMP principles for the manufacture of medicinal products. Part II covers GMP for active substances used as starting materials. The annexes provide detail on specific areas of activity. For some manufacturing processes, different annexes will apply simultaneously (e.g. annex on sterile preparations and on radiopharmaceuticals and/or on biological medicinal products). A glossary of some terms used in the Guide has been incorporated after the annexes.