Good Manufacturing Practice

White Paper

PIC/S

The 10 Golden Rules of GMP

The Good Manufacturing Practice regulations that govern pharmaceutical and medical

device manufacturing can seem overwhelming. Use these ten golden rules to drive your dayto-day operations, keeping them in mind whenever you make decisions that have GMP

implications.

This white paper is an ideal refresher for the experienced GMP professional or great training

material for the newbie.

©2013 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.

www.pharmout.net

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PIC/S The 10 Golden Rules Of GMP

What are the 10 golden rules?

Golden Rule #1

Get the facility design right from the start

Golden Rule #2

Validate processes

Golden Rule #3

Write good procedures and follow them

Golden Rule #4

Identify who does what

Golden Rule #5

Keep good records

Golden Rule #6

Train and develop staff

Golden Rule #7

Practice good hygiene

Golden Rule #8

Maintain facilities and equipment

Golden Rule #9

Build quality into the whole product lifecycle

Golden Rule #10

Perform regular audits

©2013 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.

www.pharmout.net

Page 2 of 19

Version-01

White Paper

PIC/S The 10 Golden Rules Of GMP

Golden Rule #1

Get the facility design right from the start

Every food, drug, and medical device manufacturer aims to operate their business in

accordance with the principles of Good Manufacturing Practice (GMP). It’s much easier to be

GMP compliant if the design and construction of the facilities and equipment are right from the

start. It’s important to embody GMP principles and use GMP to drive every decision.

‘Sometimes you need to step back and reconsider the

whole production area’

Facility layout

Lay out the production area to suit the sequence of operations. The aim is to...