Wright Craig, Velickovic Zlatibor, Brown Ross, Larsen Stephen, Macpherson Janet L, Gibson John, Rasko John E J
1Cell and Molecular Therapies (CMT) and Institute of Haematology, Royal Prince Alfred Hospital (RPAH) 2Gene and Stem Cell Therapy Program, Centenary Institute 3Sydney Medical School, University of Sydney, Camperdown, NSW, Australia.
Pathology. 2014 Apr;46(3):177-83. doi: 10.1097/PAT.0000000000000067.
In Australia, manufacture of blood, tissues and biologicals must comply with the federal laws and meet the requirements of the Therapeutic Goods Administration (TGA) Manufacturing Principles as outlined in the current Code of Good Manufacturing Practice (cGMP). The Therapeutic Goods Order (TGO) No. 88 was announced concurrently with the new cGMP, as a new standard for therapeutic goods. This order constitutes a minimum standard for human blood, tissues and cellular therapeutic goods aimed at minimising the risk of infectious disease transmission. The order sets out specific requirements relating to donor selection, donor testing and minimisation of infectious disease transmission from collection and manufacture of these products. The Therapeutic Goods Manufacturing Principles Determination No. 1 of 2013 references the human blood and blood components, human tissues and human cellular therapy products 2013 (2013 cGMP). The name change for the 2013 cGMP has allowed a broadening of the scope of products to include human cellular therapy products. It is difficult to directly compare versions of the code as deletion of some clauses has not changed the requirements to be met, as they are found elsewhere amongst the various guidelines provided. Many sections that were specific for blood and blood components are now less prescriptive and apply to a wider range of cellular therapies, but the general overall intent remains the same. Use of 'should' throughout the document instead of 'must' allows flexibility for alternative processes, but these systems will still require justification by relevant logical argument and validation data to be acceptable to TGA. The cGMP has seemingly evolved so that specific issues identified at audit over the last decade have now been formalised in the new version. There is a notable risk management approach applied to most areas that refer to process justification and decision making. These requirements commenced on 31 May 2013 and a 12 month transition period applies for implementation by manufacturers. The cGMP and TGO update follows the implementation of the TGA regulatory biologicals framework for cell and tissue based therapies announced in 2011. One implication for licenced TGA facilities is that they must implement the 2013 cGMP, TGO 88 and other relevant TGOs together, as they are intricately linked. This review is intended to assist manufacturers by comparing the 2000 version of the cGMP, to the new 2013 cGMP, noting that the new Code extends to include human cellular therapy products.
在澳大利亚，血液、组织和生物制品的生产必须符合联邦法律，并满足现行《良好生产规范》（cGMP）中概述的治疗用品管理局（TGA）生产原则的要求。《治疗用品令》（TGO）第88号与新的cGMP同时公布，作为治疗用品的新标准。该命令构成了人类血液、组织和细胞治疗用品的最低标准，旨在将传染病传播风险降至最低。该命令规定了与献血者选择、献血者检测以及将这些产品采集和生产过程中的传染病传播风险降至最低相关的具体要求。2013年第1号治疗用品生产原则决定引用了《2013年人类血液和血液成分、人类组织和人类细胞治疗产品》（2013年cGMP）。2013年cGMP的名称变更使得产品范围得以扩大，将人类细胞治疗产品纳入其中。由于一些条款的删除并未改变所需满足的要求，因为这些要求在提供的各种指南中的其他地方可以找到，所以很难直接比较该规范的不同版本。许多原本针对血液和血液成分的部分现在规定性降低，适用于更广泛的细胞治疗，但总体意图仍然相同。文件中使用“应”而非“必须”，为替代流程提供了灵活性，但这些系统仍需通过相关逻辑论证和验证数据进行证明，才能被TGA接受。cGMP似乎已经演变，过去十年审核中发现的具体问题现在已在新版本中正式确定。在大多数涉及流程论证和决策的领域都应用了显著的风险管理方法。这些要求于2013年5月31日开始实施，制造商有12个月的过渡期来进行实施。cGMP和TGO更新是在2011年公布的TGA基于细胞和组织的疗法监管生物制品框架实施之后进行的。对获得TGA许可的设施的一个影响是，它们必须同时实施2013年cGMP、TGO 88和其他相关的TGO，因为它们相互紧密关联。本综述旨在通过比较2000年版cGMP与新的2013年cGMP来帮助制造商，需注意新规范扩展到包括人类细胞治疗产品。
