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.
The FDA mandate that all processes and methods used to produce a regulated product must be documented and be company approved. In the majority of cases the end user wants the SOP in hard copy. The original approved SOP will reside in a safe and secure location in change control (this is a regularly audited requirement).
It really depends on your company practices and procedure (which also must be documented and approved) as to whether the SOP is in electronic format with or without e signatures. The security is by password it one instance and physical security in the other; either way to be FDA compliant the original approved SOP must be held securely, with controlled access available to authorised persons only. It is a secure system; with many approved and serialised copies in circulation and the master, under lock and key, where would you start to make unauthorised changes?
Change control must at all times (another regularly audited point) know the location of all the SOP copies in circulation and must have the capability to be able to recall them for incorporation of amendments or destruction.
As an auditor I have audited for these features for many years, I have never found a case of unauthorised SOP changes. I have found many cases where the operators failed to follow the SOP. This always puzzles me; why shoot your self in the foot over something so obvious, but a glance through the warning letters shows this is still one of the major causes of FDA citations.
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.
Are you ready for an inspection?
With HEPA filters, the manufacturers recommended dirty filter change pressure differential (PD), is only correct if the filter is used at exactly the the same air flow as the makers specify. If there is any digression (there is often as much as 50% digression) then the makers PD must be corrected. If this is not carried out you can compromise the integrity of your room / machine pressure regimes. As you are no doubt aware this would be a very serious state to be in. There are also health and safety problems that can arise, if personnel are not getting the air flow protection that is sometimes designed into the system. This test script is not in the standard OQ, and is only available here as a download. Regulators ask to review your writen justification for these filter change PD's; make certain you have them.
Purchase your copy of this test script now at Special Price of $16.00.