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Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products
V1.0, April 2013
The Australian Code of Good Manufacturing Practice (GMP) for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products (the Code) applies to Blood, Human Tissues and Human Cellular Therapy Products manufacturers that undertake the collection, processing, testing, storage, release for supply, and quality assurance of Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.
Manufacturing Licensing requirements are set out in Part 3-3 of the Therapeutic Goods Act 1989 and include requirements to comply with both general and specific conditions of licence. It is a condition of licence that, Blood, Tissue and Cellular Therapy Products manufacturers observe the Manufacturing Principles determined under Section 36 of the Act. The Manufacturing Principles require these manufacturers to demonstrate that manufacturing practices comply with the Australian Code of Good Manufacturing Practice for Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.
The TGA Manufacturing Regulator in consultation with Medsafe NZ and the Australian and New Zealand Human Blood and Human Tissue manufacturers undertook the revision of the Code. The structure of the document has been changed and is written in a less prescriptive style. It describes the way in which Human Blood and Blood components, Human Tissues and Human Cellular Therapies should be manufactured to ensure that they consistently meet specifications and are safe to use.
Therapeutic Goods Orders (TGOs) are established separately which set out specifications addressing product safety and efficacy. Manufacturers are required to develop dossiers for product groups to demonstrate that these TGOs are met.
This Code does not intend to deal with common or statute law requirements, such as Occupational Health and Safety, or the requirements for building construction.
It is not intended that the Code be used to replace procedures that are already in place, but that it be used to ensure that procedures in place meet the requirements of the Code. The Code sets out all the requirements for good manufacturing practice (GMP), which collectively ensure that the final human blood and blood components, human tissues and human cellular therapy products consistently meet specifications. While the Code describes benchmark practices that should be followed, alternative approaches are permitted provided it could be demonstrated that the intent of the Code is met in a timely and effective manner in order to meet quality objectives.
Although this Code covers all aspects of quality assurance systems and manufacture, it is not intended that any constraint should be placed upon the development or introduction of new concepts or technologies. It is acknowledged that there can be acceptable alternatives conforming to the same basic principles and achieving the same end. The manufacturer bears the ultimate responsibility for the products it manufactures.
To assist in the reading of this Code the following information is included:
- Table of Contents
- References and Recommended Standards and Publications
- A Glossary for Biologicals will be provided separately.
Although one of the objectives of this present revision was to prepare a document that would stand for several years it is recognised that amendments may be necessary to accommodate technological change, to clarify uncertainty or to specifically recognise important alternatives. Comments on the Code are therefore invited at any stage of the life of this edition.