Whistle Blowers.

As a working consultant with many years experience in being contracted out to client companies who varied from being spectacularly good to very indifferent, in their enthusiasm to comply with GMP regulations, I was quite used to tip-toeing around clients person beliefs, interpretations and egos. It was just part of the job to use what ever means were appropriate and would suffice to steer them (when required) along the chosen path of compliance. At times it was extremely hard to convince some that change was essential and you nearly always had to window dress the change and tart it up as a review, an annual update, an incorporation of new legislation, an equipment change or any other reason that would convince everyone that it was not a change, persay; because that would mean something was wrong. So you became quite adept at inventing reasons why something needed to be changed without ever using that dreaded word.

Burns is attributed with coining the catchphrase,

To convince a man against his will; he will be of the same opinion still.

How often I used to mumble that under my breath.

Bearing these thoughts in mind, I do not find it at all difficult to believe Sheryl Eckard, when she remonstrates that although she highlighted numerous compliance infringements ranging from minor to extremely serious; her company never took action to redress any of them, they were simply ignored and so was she. She eventually took these problems to the regulators and her company sacked her. The regulators move in and audited the company. Now Sheryll is to receive (from the public purse) over $90m as a reward for blowing the whistle. Who is going to be next?

Click here to listen to Cheryll's CBS news interview.

The Importance of Correct Procurement.

When an analysis of the end user's priorities, in procurement priorities, is made the importance of the equipment / programs being validateable ranks at number two out of ten.  Second only to delivery; with cost ranking around sixth. This has been true in over 80% of all cases we have been involved with.

For the-would-be purchaser, it gives enormous reassurance to know that regulatory compliant validation protocols and plans are supplied.  They are often willing to pay a 15 to 30 percent surcharge for these documents.  If a consultant is hired to produce the full suite of validation documents (8/9 documents) considerable costs are involved.  However it is the question; is the system / program actually capable of being validated?  That makes people hesitate.  I doubt (after over twenty years as an auditor) if there is any pharmaceutical company that has not at some time had to abandon new programs or equipment for these reasons.

The FDA have actually stated that 70% of validation problems are directly related to none compliant procurement methods.

Your comments about you having to validate the equipment or program are completely erroneous.  The end user has that task; your task is to ensure that your product is validatable.  That means in all ways it must be compliant with the applicable directives in cGMP.  On our site we carry further details of all these requirements.

Some of Our Current Fast Moving Documents.