GMPs

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 …

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, …

building front

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 …

data-integrity-blog

PDA suggest "Code of Conduct" for Data Integrity

Data Integrity
The Parenteral Drug Association (PDA) recently released a free “Points to Consider” document to members that outlines a number of key elements that would make up a “Code of Conduct” for Data Integrity …