At the beginning of last year (2014), I posed the above question “Should Requirements Traceability Matrices (RTMs) be formally controlled documents?” on LinkedIn because I wanted to get thoughts from people working in the pharmaceutical industry regarding how they went about it. I thank all those that have taken the time to respond. In essence,…
Is your organisation having to start, or repeat, temperature mapping efforts due to increasing regulations on warehouse storage and distribution practices? Are you facing difficulties in maintaining control of the temperature distribution within your storage areas? Are you looking to implement a simple framework of validation testing that aims to establish a sound strategy and…
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…
Validating an autoclave Purpose Validating an autoclave is a daunting and time-consuming task. This white paper details the tricks, tips and traps to such a validation project from how to choose your control to which load configuration to use for your validation runs. The white paper presents very practical steps to validate an autoclave by…
Purpose This White Paper reviews the proposed changes to Annex 15 of the EU GMP guide in detail. The draft of the revised Annex 15 was released in February 2014 by the European Commission. The draft version is based on an EMA Concept Paper that was published in November 2012. A review of the Concept…
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