FDA and Design Qualification.

Two subjects are very much in focus in recent warning letters. Whether applicable to a medical device or manufacturing process equipment, the regulators appear to be asking more often than ever to review the design qualification (DQ).

Increasingly their definition of validation is being phrased as documented verification that all the requirements in the User Requirements Specification (URS) have been satisfied. When you use this approach if there is no design qualification in place the whole validation task is fatally compromised.

However this confirmation should arrive in two stages. Stage one must be used in the early stages of the procurement process to verify that the design of any proposed items/systems will deliver all the requirements that are called for in the URS.

Miss out this stage and the actual validation can become a nightmare when the bought or manufactured item or system is found to be deficient in any design or support attributes required by the URS.

The second subject is always a favourite with auditors; steam sterilization. Even with all this interest it was staggering to read in replies to a forum query that several readers thought that when a CIP-SIP (steam-in-place/clean-in-place) system stopped several times during a pre-set sterilization cycle; due to the clean steam facility system being overloaded, it was perfectly acceptable to allow the cycle to automatically continue when the steam pressure returned to normal. In other words in a six minute validated kill cycle it stopped twice due to steam system temperature/pressure decay. However over a much longer period it did attain three two minute periods at the specified temperature/pressure. This was found to be acceptable to several of the forum members. Whether or not it left the product sterile, this would fail an audit and would fail seriously enough to warrant further action; perhaps even serious action.

1. Steam supply to each process must be validated for quality.

2. Steam quality must be re-validated annually.

3. Steam quality must be validated when ever the sterilizers are modified or moved.

4. Steam sterilizers must be validated whenever software is changed or new cycles are added.

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For Equipment:-
Combined IQ/OQ/PQ Equipment Protocol (Issue-2).

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.

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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 written justification for these filter change PD's; make certain you have them.

Purchase your copy of this test script now at Special Price of $26.00

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