We have been inundated
with queries and comments regarding our last newsletter. The basic undertone from these queries
and comments was; incredulity as how we could develop such a complete User
Requirements Specification (URS).
These remarks tend to substantiate a FDA
comment that perhaps up to 75% of validation citations could be attributed to; a
complete lack of, or poorly documented procurement procedures.
All reviewing regulators
are expecting and inspecting to verify that all predicate activities are
executed in accordance with documented company approved procedures. Raising a URS is one such
The validation manager
(or the person identified in the quality system as responsible for all
validation activities) is required to ensure that company approved procurement
procedures are available and used by all personnel involved in procurement
activities. All parties;
engineering, production, procurement, human resources, quality control and
assurance, must sign-off a check-sheet detailing all aspects of this validation
task have been considered.
Failure to ensure that all
purchased or otherwise received product and services conform to specified
requirements; and failure to implement written purchasing control procedures, as
required by 21 CFR 820.50.
Specifically, you have not
established requirements, including quality requirements that must be met by
your suppliers and contract manufacturers; and have not documented your
evaluation of suppliers and contract manufacturers. (FDA archives)
project we were brought in to expedite was found to be derelict in not
requesting or investigating;
Ø As built
Ø Calibration standards
Ø Quality Steam & Water
system. s (insufficient capacity).
Ø HVAC system (Room
airflows needed to increase drastically).
These four items delayed the handover of the project for twelve
months and doubled the cost.
Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00
combination protocol has been produced in response to several hundred
suggestions we received in our ‘Suggestions
Section’. It has been carefully
designed to make it the preferred choice for Process and Laboratory
equipment. It is an interactive, fully detailed, sixty three page
runs to approximately seven thousand words. It is presented in 'MS
facilitate ease of final editing by the end user. It has become a very
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.