Global GMP – a comparability study to link good manufacturing practice standards for world wide compliance within the cellular therapy industry

      GMP Standards ensure product safety within cellular therapy fields, a fully harmonised global standard remains elusive. There is an emerging need for standardisation with respect to GMP. The difference between individual country's regulatory GMP requirements, prohibits manufacturers from complying with GMP Standards globally. Manufacturers cannot actively promote cellular therapy treatments in other countries with higher GMP Standards. The cost to implement higher GMP Standards is prohibitive and lengthy. Reducing the number of cellular therapy treatments utilized overseas restricts the potential for global advancement in cellular therapies. A global GMP Standard capable of meeting equivalent governmental regulatory requirements worldwide is proposed allowing manufacturers to utilize their cellular therapy treatments universally. Improving potential for global GMP Standard harmonisation a comparison between the GMP Standards enforced by Governmental Regulatory Bodies is proposed. The process of determining major differences between the PIC/s Guide to Good Manufacturing Practice for Medicinal Products Annex 13; Australian Code of GMP for Human Blood and Blood Components, Human Tissues and Human Cellular Therapies - Australian Therapeutic Goods Administration (TGA); Clinical Trial Handbook and Clinical Practice Guidelines – TGA; Australian Regulatory Guidelines for Biologicals (TGA); Unapproved Therapeutic Goods Guideline TGA; In Vitro Diagnostic Medical Devices TGA; Australian International Conference on Harmonisation Guidelines (ICH); Committee for Proprietary Medicinal Products (CPMP); European Medicines Agency (EMEA) and Federal Drug Administration Guidelines (FDA), is the focus of this study. These observations conclude that there are differences between the Standards, GMP Standards are similar and a robust global Standard harmonisation is achievable if have one common goal – product safely produced in accordance with standardised good manufacturing practice.
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