GMP Basics of Good Documentation Practices (GDocP)
Good documentation practices (GDocP) are key components of GMP compliance. Good record-keeping not only helps you during regulatory inspections (GMP audits), it is mandatory to ensure your documentation …
Congratulations Colin Byrne
PharmOut is delighted to announce that Colin Byrne has been promoted to the role of Senior Consultant.
Colin has over 12 years of experience in the pharmaceutical industry, including more than 4 with …
New partnership offers cost-effective paperless validation to GMP – governed organisations in Australia.
PharmOut, the Asia Pacific’s leading Pharmaceutical consulting organization, has announced a strategic partnership with ValGenesis Inc, a pioneer in paperless validation software …
On the 30th of March, the EU released its updated version of Annex 15 Qualification and Validation which will be effective on 01 October 2015. In this article, I will discuss the changes between the draft version and the revised Annex 15 version.
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 …
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 …
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 …
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 …
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 …
The debate on the number of batches used to determine if a process is validated or not has come under some scrutiny since the update of the US FDA’s Guide to Process Validation in …
