GMPs

gmp-training-course

Take the 2016 GMP or the Clean Room quiz

How familiar are you with the common concepts of GMP? If you feel you are up to the challenge, test your knowledge by taking the GMP Quiz Master challenge, if you are brave enough, …

hand-written-question-mark

Fading thermal paper – an indelible record?

The practice of making true copies of thermal paper.
Last week I was asked an interesting question relating to making true copies of thermal paper. We all copy thermal paper but the question was: ‘Where …

autoclave detector

Air Detectors in a GMP environment

What are they and where did they come from?
Air detectors were first developed in the textiles industry where autoclaves are used in a process called ‘heat setting’ for yarns and synthetic fibres such as …

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.

Comparison of Medical Device Standards

Whitepaper – ISO13485 & US FDA CFR 820 Comparison

Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for …

Technology-in-the-hands

Embracing an electronic quality management system

Electronic Quality Management Systems (eQMS) have gained increasing popularity within the healthcare industry over the last decade. The following diagram shows the various processes for which management, communication and workflows can be automated via the use of an eQMS