Michael:
Your subject line: ISO vs GMP may be designed to be provocative,
suggesting that these two standards compete, one with the other, for
a common customer base. I suspect that I am rising to your bait!
Bait or not, ISO 9000 series quality standard represents a baseline
for anyone who may have an interest in 'quality' as the underpinnings
of their business growth/improvement.
While there may be no regulatory reason to become ISO 9001 certified
if one is GMP compliant, I do believe that sort of thinking sends the
wrong message. It may, for example, send the message that quality is
only important if a regulator has required it. In the case of ISO
standards, and by way of example, the 13000 and 14000 series would
apply.
There are, in addition, national quality standards in play, such as
Congress-endorsed Baldridge in the USA (Canada, Australia and the EU
have similar government endorsed arrangements) which have similar
goals to those standards of the ISO but do more, such as aims across
corporate structures via -a- vis improvement, performance/outcomes
measures to standardize those elements of business process
improvements directed,or amenable to, society standards of
performance. The message here is that CORPORATE (as opposed to
Division/Department) quality pursuits can be shown to make a
significant contribution to corporate financial health, or any other
similar yardstick, no matter what your business is.
I can, therefore, certainly suggest that a manufacturing business
entity that is GMP compliant would also benefit from the pursuit of
Baldridge, if located in the USA, or some other similar national
standard with Baldridge-like aims. One or more of these groups have
published data in an effort to show how compliance ( to their
requirements) goes straight to the 'bottom line'.
Many of these multiple standards embrace elements which are akin to
one another. Government has acknowledged this in their incorporation
into law of ISO 13000 series standards for medical devices
regulations and 14000 series standards for environmental compliance.
Is GMP compliance important? Yes. Why is it important? Because it is
the law? Or because, if followed, the outcome is a safe and effective
product? The latter I hope. GMP does not as much for effective
processes in HR, Communications, Finance, Controller, Accounts
Payable, Accounts Receivable, Legal, Premises (other than
manufacturing),Investor Relations, etc. If you have a totally
compliant manufacturing/QC group....great....but that alone will not
necessarily make you (the organization) the best that you can be in
terms of financial performance that all of us require.
Kind regards
J. W. Rees
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