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 activity.
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)
A project we were brought in to expedite was found to be derelict in not requesting or investigating;
Ø As built drawings.
Ø Calibration standards (nuclear).
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.
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
Protocol (Issue-2). -- $159.00
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.
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 them.
Purchase your copy of this test script now at Special Price of $16.00.