Validation Contentious Points, Point 4 of 10.
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.
Number Four we have:
Client document reviewing and
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
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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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
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?
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.
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
Purchase your copy of this test script now at Special Price of