Validation Contentious Points, Point 4 of 10.
There are many simple and quiet straight forward tasks that if we had know about them and tackled them at an early stage we would have delivered our validation project through on time, within budget and with a lot less hassle. We have documented what we consider to be the top ten of these tasks and will issue then one at a time in a random mix in our next ten news-letters.
At Number Four we have: Client document reviewing and approving.
The client nearly always insists on reviewing and approving consultant prepared documents, prior to their use. These tasks are the most consistently under manned tasks in projects. After many project disputes about what were or are the actual choke points in project progress, we started to advocate that a simple progress plan was set out to display, to all, the time involved in this task.
Use a planning tool such as Microsoft Project. Meet with the client or your peers, and jointly agree that the times allowed for the various tasks, is a time they can and will work to. Agree how often a document should be reviewed (is each person going to review concurrently, consecutively or is every one circulated and given a set time to return document with their comments). If one person is on holiday or sick leave, consecutive reviewing could mean that the reviewing process will stop at his desk and reviewing, in general, could choke to a standstill. Reviewers should be nominated by job title and at the very least one deputy should be nominated for each title. A time limit must be set for each title holder to review each document and the number of reviewers ideally should not exceed three.
A small project may involve (just for discussion) 20 items requiring validation. That is, 20 (IQ's)(OQ's)(PQ's), that have to be authored, reviewed (once), approved for use, and reviewed for final approval. Using these hypothetical figures we can start to estimate the reviewing task. The reviewers have to review, 60 documents 3 times. A total of 180 reviews, if we have 10 reviewers (an extreme, but often factual), that comes to a total of 1800 reviews. If each document lies on a reviewers desk for 4 days this could be 7200 days. Now allow for the documents that will get lost (miss-filed, tea spills etc), and it quickly becomes evident that unless this side of the validation effort is very rigorously controlled, anarchy will prevail. It is at this stage that we learned to construct a simple plan for Document Review Manpower Requirements. The manpower required always amazes the client, however, once they agree the parameters and have been served with the documented forecast, the onus is on them to perform to the parameters they agreed, or provide additional resources. As a consultant in charge, you are failing your client if you do not get this out into the open and a solution agreed; long before reviewing commences.
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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.
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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.