GMP Work Experience Assessment.
Testing standards for persons employed in cGMP
The number of regulatory
citations for training; or rather lack of cGMP training, is ever
Also there is an
increase in the number of citations for persons not having adequate documented
proof that they are actually competant for the tasks they are being ask to
Even in house staff have
been challenged by visiting regulators. A recent citation claimed that a QA manager; although adequately
qualified, did not have any documented prove of actual validation practices
experience. The regulators are also
keen to have the competancy of agency staff verified. During a regulatory review of protocols
they expressed surprise that the QA manager had not taken any action to verify
the CV’s of agency staff.
This is a problem we are all
well aware of. Who checks out
agency staff CV’s? Certainly it is
not the agencies that refer them, they could never justify the cost of retaining
qualified and experienced staff to vet and verify the experience and
qualifications for all the disciplins they recruit for. Large companies probably do have the
staff, but not the time for such activities. Smaller companies generally use agency
staff because they lack this skill set.
Validation Online is
currently writing a pool of questions covering all aspects of validation.
These will be built into a multiple
choice question paper. The question
pool initially will be circa 400 and the test paper will contain 50
questions. It is intended to ensure
that a qualified competant multi-disiplined person should be able to
score in the region of the high 80’s. With lessor skill sets scoring accordingly.
We see this as
being an excellent tool for the validation manager to assess their own staff or
potential staff and to set an acceptance level for agency staff, while
establishing records of staff competance. If you could be kind enough to submit
your comments in the form below; It would greatly
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 stand-alone equipment. It is an interactive, fully detailed, sixty three page protocol that runs to approximately seven thousand words. It is presented in 'MS Word' to
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.