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.

What’s your cleanroom costing you?

What’s your cleanroom costing you?

To answer the question, we looked at the fact, on average, as much as 80% of the total energy used by a cleanroom is consumed by the heating, ventilation, and air conditioning (HVAC) system. Up to 50% of this …

GMP Quiz 2016

New 2016 GMP Quiz

A New Year a New GMP quiz!

You’ve probably already done the old quiz, so test your updated GMP knowledge with the latest PharmOut 2016 GMP quiz.

All new questions have been developed as well and a handy little hint is available …

pics tablets

Update from PIC/S Meeting in Geneva

The PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Sub-Committee on Training Meeting took place in Geneva between 28-30 May 2013. The main topics that were discussed are summarized below.

A new Sub-Committee structure of PIC/S will enter into …