Qualification & Validation

PharmOut Compliance, Validation, Engineering

Senior GMP and Validation Consultant

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 PharmOut. He has gathered a …


EU releases Annex 15 validation and qualification

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.

GMP Vendor Management Audit Program

Requirements Traceability Matrices (RTMs)

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 …

temperature mapping

Understanding Temperature Mapping

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 …