asked me to start of this discussion with some pretty evocative discussion
points. The importance of
validation in the business of delivering product of the right design efficacy
and quality to the end users is not diminishing in any way. In fact the legislators are currently
under enormous public pressure to reassure all; that all aspects of GMP are
being rigorously enforced. So what
action is required?
Is the move to ‘Risk Based’ actions correct, or is it simply an
opt-out, releasing the regulators from the burden of documenting specific
requirements and allowing them to adopt the tenure – you tell us what your doing
and we will tell you if it is adequate?
In our industry a ‘Risk Analysis’ is a tool used to define the
minimum actions required to achieve compliance with a requirement, where as, in
the aviation industry it is used to remove all possibility of a failure to
comply, subtle difference, or an extremely important divergence?
In our industry process instructions are documented in SOP’s,
where often they are quite casually worded, at times being little more than an
‘aide memoire’. Once again
when we compare this to aviation process documents, we find a vast difference,
they are laid out as legally enforceable documents, containing exact and precise
instructions that the operator must follow and is require to sign, as each
action is completed. Supervisor
checks are integrated into the operators process and must be signed off as
progress is made. Where critical
stages arise, independent checks by persons not involved in the process, are
mandated. Are our SOP’s as adequate
or do we require more thorough process documentation along with better
management of it?
Or are we looking at the wrong end of the industry for step
changes. Do the real problems lie
with bringing inadequately tested drugs onto the market? If they are inadequately tested then
For my last bone of contention let me raise the problem of the
‘Whistle Blower’. A person of
integrity or a vindictive nuisance maker?
A well known American legend took on the Chicago Motor Mongols and after
bitter in-fighting won. A
doctor with simply appalling patient survival statistics was caught by the legal
profession when he forged a will, not by the medical profession for the murder
of 220 patients. Why did persons
around him not ‘blow the whistle’.
Was it because there was not a whistle available to blow. Then maybe we should look at the
possibility of making whistles available for individuals in the industry to
report when requirements are being abused or blatantly ignored.
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