GMDP FOR THE 21st CENTURY Part 1

Pipe dream or real-world possibility?

WHAT IS GMDP?

GMDP, if you don’t already know, stands for Good Manufacturing & Distribution Practice. These are the EU (adopted by UK post-Brexit) Rules governing the development and manufacture of medicines, often termed the Orange Guide.

These regulations have legal standing, and if any company is found to have breached one or more of the Regulations, they could face a visit from the regulatory inspection and/or enforcement team. That could mean the business must stop trading, in an extreme case.

WHY THE 21st CENTURY?

It is generally accepted in the industry that adherence to the regulations is essential to keep patients’ safe, but they have not moved with the times.

In other more customer-focussed sectors, modern production methods have transformed quality, cost, safety and customer service levels.

In pharma, the main consideration is to follow the regulators dictate.

A former editor of GMP Review, previously VP Global Quality at GSK, Peter Savin, had the to say about GMP:

For some reason,…