Validation of Climate Controlled Cabinets and Rooms
New documents from Validation Online:
Protocols: Climate Controlled Cabinets and Rooms.
IQ, OQ and PQ protocols now available along with combined IQ/OQ/PQ and the whole suite of documents starting with the VP and following with VRA - IQ – OQ and completing with the PQ.
Click Here for further details.
If your warehouse stores regulatory controlled product - then it is that product's storage requirements, which dictate what conditions must be maintained within the warehouse. If the product has restriction on storage temperature and or humidity, then you must verify through validation that while the product is stored in the warehouse it will be stored within the stipulated temperature and humidity parameters.
So, if the product has no limitations, then there is no validation required. If the product has limitations, then you design you qualifying protocols to show that the product is always maintained within the required parameters.
It is up to you to develop a justification for the time between logging parameters. Experiment - leave the door open or turn the HVAC plant off - then note how long it takes for the system to sense the change. If the system takes 30 minutes to notice a 1% change, and your tolerance is plus or minus 3%. Then you could quite easily justify logging parameters every 15 minutes. What ever you do, document and justify it in your OQ.
Total logging time - log for two complete weeks to cover all dynamic times when the warehouse is in use and all the static times when it is out of use.
If you have a critical product - then you will have to verify the above, during the hottest, driest, coldest and wettest local ambient climatic conditions the warehouse will have to operate in.
This usually means running the two week (minimum) logging exercise, when you are validating and then again once, or twice more. Or however often is required to verify that storage conditions were not compromised by local external ambient weather conditions. You are also required to verify that these runs were actually executed during these adverse climatic conditions. So you need to log the outside climatic ambient conditions.
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.