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.  


Combined IQ/OQ/PQ Protocol for Quality Steam.

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.


SOP for Quality Steam Testing (SOP-QST).

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.


Please click here and let us know of any purchasing problems.

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.

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.

The SOP for Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
Purchase your copy now at Special Price of $ 22.00.


Some of Our Current Fast Moving Documents.

Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00

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