THE EVOLUTION OF 21 CFR PART 11.

Alex has 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?

1) 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?

2) 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?

3) 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?

4) 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 why?

5) 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.

Since the popular SOP for Equipment Validation is very often purchase along with the equipment validation IQ/OQ/PQ protocols, it was decided to make the purchase more attractive and easier by bundling all four document into a package and offering a discounted price for the packaged documents. This package contains the:

SOP for Equipment Validation, plus IQ/OQ/PQ Individual, Interactive & Fully Detailed Protocol Templates. All for the very competitive price of $250.00.

It is anticipated that certain PC game consoles and accessaries will be sold out well before Christmas time. So, if your are intending to buy one: