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Date Submitted: 02/28/2013 11:35 AM
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
Page 1 of 19
Version-01
White Paper
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...