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.
Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00
Combined IQ-OQ-PQ Computer Protocol (Issue 3) -- $159.00
Software Validation SOP (Issue-2) -- $22.00
Software Validation Master Plan (issue-2) -- $115.00
Software Validation Risk Assessment (Issue 2) -- $125.00
Software User Requirements Specification. (Issue 2) -- $115.00
Software Validation Plan (Issue 2) -- $89.00
Software Design Qualification. (Issue 2) -- $89.00
Software Installation Qualification. (Issue 2) -- $89.00
Software Operational Qualification. (Issue 2) -- $89.00
Software Performance Qualification. (Issue 2) -- $89.00
Software Validation Package (Issue 1) -- $699.00
A recent warning letter demonstrates just how few companies use a Gap Analysis to validate that they are compliant. CAPA discrepancies continue to be the biggest single source of problems. However the daddy of them all recently has been a well known company that had carefully documented the levels of experience and educational standards required for various GMP sensitive roles (In accordance with GMP), only for the FDA to find the persons in these jobs were not qualified properly. (click here to read)
Do use a Gap Analysis and avoid these embarrassing events. Gap Analysis Tool (Issue 2.) -- $115.00
Validation Risk Assessment (Issue10.) -- $125.00
This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.