Regulatory Warning Letters.

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.

Steam Quality Validation.

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 SIP-CIP (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. 

Other items discussed regarding steam sterilizers.

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

2.                  Steam quality must be revalidated 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.  

This is a very detailed and comprehensively scripted protocol.  All the test scripts required for IQ/OQ/PQ execution are in place ready for editing to represent your installation exactly.  Tests scripts are very detailed and all calculations are broken down into simple stages.  Illustrated equipment hook up diagrams and sequential instructions further ensure that this testing is easily within the skills of the average technician. 

All sterilization tasks using steam attract the attention of the regulators.  There are often serious problems that inhibit or reduce the sterilizing efficacy of steam that remain obscure to the operator and only become apparent to the end user. 

The power of steam to sterilize is very closely linked to the characteristics of that steam.  Routine steam quality testing must be carried out to ensure that your sterilization processes are never compromised.  Annual testing of steam automatically attracts auditor attention.  Steam quality must be re-verified when ever any changes or disturbances affect a qualified quality steam system.

Combined IQ/OQ/PQ Protocol for Quality Steam -- $565.00
Includes Expansion and Pitot tubes.

This is a fully documented and detailed SOP that you will use every time you execute your periodic re-qualification of your quality steam system(s).  Tests scripts are very detailed and all calculations are broken down into simple stages.  Illustrated equipment hook up diagrams and sequential instructions further ensure that this testing is easily within the skills of the average technician. 

The main reason people have traditionally contract steam quality testing out, was that the hardware (pitot and expansion tubes) were extremely difficult to obtain.  We have had these manufactured for our own use and include them in this offer.  All other test equipment required is readily available in most laboratories (tubing, glassware and multi-meter). 

This SOP is an absolute must for companies that want to be certain that their sterilization processes are never compromised.  Annual testing of steam automatically attracts auditor attention.  Steam quality must be re-verified when ever any changes, including software, affect a qualified quality steam system.    

SOP for Quality Steam Testing. -- $499.00
Includes Expansion and Pitot Tubes.

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Free Validation Document Downloads.

SOP Security.

The FDA mandate that all processes and methods used to produce a regulated product must be documented and be company approved.  In the majority of cases the end user wants the SOP in hard copy.  The original approved SOP will reside in a safe and secure location in change control (this is a regularly audited requirement).

It really depends on your company practices and procedure (which also must be documented and approved) as to whether the SOP is in electronic format with or without e signatures.  The security is by password it one instance and physical security in the other; either way to be FDA compliant the original approved SOP must be held securely, with controlled access available to authorised persons only.  It is a secure system; with many approved and serialised copies in circulation and the master, under lock and key, where would you start to make unauthorised changes?

Change control must at all times (another regularly audited point) know the location of all the SOP copies in circulation and must have the capability to be able to recall them for incorporation of amendments or destruction.

As an auditor I have audited for these features for many years, I have never found a case of unauthorised SOP changes.  I have found many cases where the operators failed to follow the SOP.  This always puzzles me; why shoot your self in the foot over something so obvious, but a glance through the warning letters shows this is still one of the major causes of FDA citations.