global GMP expertise
globepharm mouseover the menu bar for more information  
globepharm mouseover the menu bar for more information
mouseover the menu bar for more information mouseover the menu bar for more information
 
top
consultancy work
Training
In-House Training
Individual e-Learning
Public Seminars
Executive Lunch Series
expert witness
ask a GMP expert
What is GMP link
Links to resources worldwide below
gmp codes link
regulatory agencies link
industry trade associations link
colleges of pharmacy link
daily news
about us
contact us
home
menu bar
 

International GMPs

Contract Manufacture and Contract Analysis

The European and International GMP codes (PIC and WHO) have extensive sections regarding the roles and responsibilities of contract giver and contract receiver when pharmaceutical manufacturers sub-contract either parts of the manufacture or the testing of the pharmaceutical product.

It is FDA’s position that whether a company manufactures/tests a product itself, or whether it contracts this activity out to others, such a decision is purely an economical one – the manufacturer’s decision to make in-house or contract-out being purely dependant on which option is the best business decision. As such, although there is no specific GMP regulation per se, FDA holds the manufacturer responsible for all aspects of GMP non-compliance by the contractor. This onus is taken to extensive lengths as witnessed by a warning letter issued by FDA in 2002 that held a pharmaceutical manufacturer liable for GMP non-compliance of its contracted software company. The GMP non-compliance was that the software company had not provided GMP training to its software programmers – a basic GMP requirement stated in the GMP regulations.

 
   
   

 

Copyright © Globepharm • Website hosted by XO Communications