GMPs

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PIC/S Version 13 is here, are you ready?

For Australian and New Zealand Manufacturers PIC/S Version 13 is due this year, aside from significant changes in Part 1, there are also significant changes in Annex 11, Computers Systems and Annex 15, Qualification …

2015 MHRA GMP Inspection Deficiency Data Trends

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are …

10 tips to improve your quality management system

Quality Management System Documents
A well-written document with a comprehensive and well designed Quality Management System (QMS) can be a manager’s best friend. They are our daily guidance and instructions for our staff, the ‘go-to’ …

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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 …

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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, …

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Lean Pharma Plant Design

Lean Pharma Tips
I think everyone has heard of the 7 Lean Manufacturing Wastes, increasingly we hear that an 8th Waste has been added – Skill.

Over the years, and with my failing memory, I have learnt that …