PIC/S

data measurements

MHRA: Data Integrity defined?

In July 2016, the MHRA released a draft document for consultation entitled MHRA GxP Data Integrity Definitions and Guidance for Industry.  As the name suggests, it is a glossary of DI terms where the …

application PIC/S membership

PIC/S launch new website

PIC/S have just released a new, responsive website that allows for easy viewing on both desktop and mobile devices. The website reflects the change from the black and white PIC/S logo to the red, …

pics tablets

PIC/S GMP – 3 reasons why you should care

1. Over 70% of world drugs are produced in PIC/S GMP facilities (member countries or companies)
With the US FDA joining PIC/S in 2011 and many other agencies in the queue, compliance with the PIC/S …

EU-flag

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.

pics tablets

Update from the PIC/S Seminar on Dedicated Facilities

Dedicated Facilities
Last week, I published a blog titled “Dedicated facilities or not?” and I surmised that trying to guess where regulations on cross-contamination were going, it was like gazing into a crystal ball. Well, …

cross contamination risk

Dedicated facilities or not?

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.