Good Manufacturing Practice Quiz This Good Manufacturing Practice Quiz stresses the importance of GMP, which is the cornerstone of product quality. Sound GMP knowledge and the application of GMP are the bedrock of compliance. GMP rules in simple terms relies on you to document what you are going to do, do it and then you…
The ICH Steering Committee and its Expert Working Groups met in Belgium in June 2013. The Steering Committee agreed measures aimed at increased transparency in pursuit of greater harmonisation and will provide more detail to the public via the ICH website, including agendas and the reports of meetings as well as the work plans of…
The PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Sub-Committee on Training Meeting took place in Geneva between 28-30 May 2013. The main topics that were discussed are summarized below. A new Sub-Committee structure of PIC/S will enter into force on 1 January 2014. It foresees a more participative and efficient organisation where each…
In April 2013, the Australian Therapeutic Goods Administration released the first version of its much anticipated Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products. These requirements commenced on 31st May 2013 with a 12-month grace period requiring full compliance by 31st May 2014. Within…
Every single medicinal product in transit, in any part of the world, is potentially at risk of falsification. The US based ‘Centre for Medicines in the Public Interest’ (CMPI) estimates the value of the counterfeit drug sales in 2010 in the vicinity of $75 Billion USD. A falsified medicinal product is any medicinal with a…
TGA adoption of PIC/S GMP Guide for Medicinal Products Which version of the PIC/S GMP Guide does the TGA refer to? PIC/S Version 14, PIC/S Version 15, or PIC/S Version 16? PIC/S GMP Guide PE 009-15 (PIC/S Version 15) was published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in May 2021. This version (Version 15)…
TGA REFORMS – HISTORICAL DOCUMENT (blog originally published 21 May 2013): The TGA has released an exposure draft of a Regulation Impact Statement (RIS) on proposed changes to premarket assessment requirements for medical devices. The RIS is in response to the earlier consultation document on device reforms, released in January. The RIS provides details on…
Manufacturers of products, especially of sterile products produced by aseptic processing, have a significant challenge to create and manage an effective environmental monitoring programme, with their available resources.
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