GMP Violations and Citations.
As this year
draws to near its ending it is sad, frustrating and worrisome to read an FDA
Warning Letter (WL) that cited a company for using a Design Qualification
(DQ) protocol in which 75% of the test scripts had no Summation of Test Results.
How is it possible for a company to
produce a protocol that is so appallingly inadequate? A DQ is subjected to several peer
reviews and in its final acceptable form; review and sign off by management.
here (its free) and ensure your test scripts are formatted correctly.
shocking to see companies shooting themselves in the foot as above, but the next
WL not only proves that it happens all the time, but also shows the enormity of
it. This WL
concerns a company carrying out EO sterilization of regulated product for
third parties. Their obvious total
disregard of the cGMP requirements means that all the sterilizations they
contracted to do, have been categorized as ‘Adultered’. The enormity of this is absolutely
staggering since the product so categorized; has all been consumed and or
applied and or implanted. Do you
use subcontracting companies? If
so; do you have a completed approved Vendor Audit
document that verifies their cGMP status and will it stand up to regulatory
inspection and perhaps even judicial judgement?
year has seen us introduce several new documents and document packages. The most popular new documents haves
undoubtedly been the combined IQ-OQ-PQ protocol
and SOP for equipment, followed very closely by the IQ-OQ-PQ protocol and
SOP for computers. These
documents have been supplied to customers in 22 different countries and to circa
60% of the multinationals. As a
trial we soon be offering these documents not only through our normal PayPal payment
process; but also using Google Checkout.
If Google appears popular we will offer it as an alternative on all
sales. In the meantime if
you want to make a purchase and can’t or don’t want to
use PayPal, please CLICK IN BOX BELOW and lets us know how we can assist.
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.