RO Water for Injection? Allowed by the European Pharmacopoeia from April 2017? The European Pharmacopoeia Commission recently announced the revision of monograph 0169 to allow for generation of EP Water for Injection (WFI) “by a purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques”. These changes will align the EP with the…
As the gap between current EU/PIC/S GMPs and Australian GMPs widens, is the TGA losing relevance? Last week, I was speaking with a respected Senior Quality Executive from a leading Australian pharmaceutical manufacturer, I was surprised when they stated that they no longer prioritised TGA inspections or findings. This is in stark contrast with my…
How familiar are you with the common concepts of GMP? If you feel you are up to the challenge, test your knowledge by taking the GMP Quiz Master challenge, if you are brave enough, login and leave your details, or you can do the test anonymously. Want to read “The story of Joe and his…
The practice of making true copies of thermal paper. Last week I was asked an interesting question relating to making true copies of thermal paper. We all copy thermal paper but the question was: ‘Where does it say that in the regulations that this needs to be done?’ One of the challenges when training new…
GMP Annex 1 – sterile manufacture In January PIC/S and the GMP/GDP Inspectors Working Group (on behalf of the EMA) agreed on a concept paper regarding the long awaited update to Annex 1, the primary GMP guidance on sterile manufacturing for Europe and PIC/S member countries. The current version of Annex 1 dates from 2007,…
What are they and where did they come from? Air detectors were first developed in the textiles industry where autoclaves are used in a process called ‘heat setting’ for yarns and synthetic fibres such as nylon. In the textiles industry, autoclaves are used to improve and/or add certain properties to fibres, such as dimensional stability,…
Only a brave person would try to guess where the EU GMP regulations are going for medicinal products produced in shared manufacturing facilities. At the moment, it is a little like gazing into a crystal ball, trying to understand the consensus of the many participating authorities involved, with their often strongly differing views based on their in-country experiences (disasters). Existing facilities really only have “Organisational Measures” to control the potential risks of cross-contamination, as often it is impractical to retrofit the “Technical Measures” as referred to in Chapter 3 and 5 in the EU GMP guidance.
Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for medical device manufacturers and importers. ISO 13485, a voluntary quality standard, provides a framework for meeting medical-device quality requirements in the…
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