The Good Manufacturing Practice (GMP) is the part of quality assurance that ensures that products are consistently manufactured to the quality standards appropriate for their intended veterinary use and in accordance with their registration particulars and specifications. GMP is concerned with both production and quality control. It is a means of giving consumers confidence that the products meet the required quality standards and are safe and reliable for the purposes for which they are intended. The basic requirements of GMP are that: a) all manufacturing processes are clearly defined, are systematically reviewed in the light of experience, and shown to be capable of consistently producing veterinary chemical products that comply with their specifications and the required quality standards; b) critical steps of manufacturing processes and significant changes to the processes are validated; c) all necessary facilities for GMP are provided, including: (i) appropriately qualified, trained or experienced personnel (ii) adequate premises and space. This Code of GMP is in two parts: Part 1 deals with the basic principles or core elements of GMP and applies to all sectors of the industry, all types of products and all sizes of manufacturing plant. Part 2 contains the Annexes. These describe additional or modified requirements and guidelines for specific sectors of industry, such as manufacturers of sterile and immunobiological products, ectoparasiticides, premixes and supplements. These Annexes supplement the core elements in Part 1. They do not replace them, and should be read and applied in conjunction with the relevant core elements. The intent of each core element is described in the manufacturing principle(s) at the start of each chapter and all manufacturers are required to comply with these principles. The guidelines for each chapter provide guidance as to what manufacturers are expected to do in order to comply with the relevant manufacturing principle(s). Additional guidance material is provided in documents such as the European Pharmacopoeia, international and Australian standards, PIC/S guidelines and other relevant reference material, and manufacturers are expected to refer to such references where appropriate. The revised GMP Code places greater emphasis on the need for manufacturers to maintain an effective quality assurance function and to periodically undertake a scientifically based risk assessment of their processes and procedures. In this regard, it is expected that manufacturers will embrace a culture of continuous improvement and that manufacturing practices will be progressively updated in line with technological developments.
Australie · 2007-03-29