Pharmaceutical Validation Problem 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.
I would like to make a purchase using Google/PayPal
The Importance of Correct Procurement.
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.
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.
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.