Lean Pharma Tips I think everyone has heard of the 7 Lean Manufacturing Wastes, increasingly we hear that an 8th Waste has been added – Skill. Over the years, and with my failing memory, I have learnt that I need an easy way to remember the “wastes”, especially when I’m out front training a class, so my…
A lighthearted look at the things that can go wrong with a clean room design, right in time for the holiday season. A Christmas gift Yah! Joe had finally gotten approval to build a new clean room as part of the building project he was responsible for. They desperately needed it to make the new…
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,…
Last week, my colleague Kate Wild wrote an interesting blog on GMP SOP writing, and it prompted me to think about how we write, review, approve and execute qualification and validation protocols, so all about qualification protocol execution. In essence, an approved protocol is used to record the relevant details from the successful testing of…
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