This white paper describes the changes outlined in the Draft International Standard (DIS) editions of ISO 14644-1 and ISO 14644-2 relating to clean room & clean air device classifications: ISO 14644–1 and ISO 14644–2. When the standards are published towards the end of 2012, changes will have to be made to the way every cleanroom and…
The number of medical Apps on both the Apple and Android platforms is increasing and mobile technology is increasingly being embraced by healthcare professionals, especially since the pandemic. With the increase in medical software programs and medical technology, such as robotics and diagnostic software, it’s important the manufacturers are aware of the regulatory requirements (Regulation…
The PIC/S pipeline This article is part of a historical series of discussions relating to PIC/S GMP changes (2011). Continuing on from our last post, the following changes are happening or have happened to the PIC/S GMPs: Annex 2 Biological Medicinal Products has progressed through the public consultation phase. Annex 11 Computerised Systems has now…
In trying to work out what is in the PIC/S GMP Pipeline we examined the Health Products Regulation Group (HPRG) of Singapore’s Health Sciences Authority (HSA) held a regulatory workshop on Good Manufacturing Practices for Medicinal Products Manufacturers held in January 2011. One session, conducted by the HSA’s Boon Meow Hoe traced the history, current…
Current PIC/S GMP Guides On January 15, 2009 the PIC/S The Pharmaceutical Inspection Cooperation Scheme – PIC/S released its ‘PE009-8’ Guide to GMP document. This is the current code of GMP relevant to Australia’s Therapeutic Goods Administration TGA – Therapeutic Goods Administration and medicinal product manufacturers. This document saw several significant changes, including; Revised Annex…
In January of 2011, the Health Products Regulation Group (HPRG) Health Sciences Authority (HSA) held a regulatory workshop on Good Manufacturing Practices for Medicinal Products Manufacturers. One session, conducted by the HSA’s Boon Meow Hoe, traced through the history, current applicability and future trends of PIC/S GMP. PIC/S History PIC/S has been at the forefront…
HISTORY of Chinese GMP guidelines Updated GMP guidelines were issued by the Chinese SFDA in February 2011, and went into force starting March 1st, 2011. This blog discusses historical changes in Chinese GMP guidelines and includes links to articles from the World Health Organisation (WHO). Chinese GMP updates from 2011 Chinese GMP vs the EU…
What the requirements are and how to cost effectively comply The TGA’s code of GMP recommends that all suppliers be qualified – “The process of assessing the reliability of a supplier to consistently provide material of acceptable quality”. For complementary manufacturers with many, many suppliers, qualifying them all is an onerous and expensive exercise. For…
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