Regulatory Warning Letters.
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.
The Importance of Correct Procurement.
When an analysis of the end user's priorities, in procurement priorities, is made the importance of the equipment / programs being validateable ranks at number two out of ten. Second only to delivery; with cost ranking around sixth. This has been true in over 80% of all cases we have been involved with.
For the-would-be purchaser, it gives enormous reassurance to know that regulatory compliant validation protocols and plans are supplied. They are often willing to pay a 15 to 30 percent surcharge for these documents. If a consultant is hired to produce the full suite of validation documents (8/9 documents) considerable costs are involved. However it is the question; is the system / program actually capable of being validated? That makes people hesitate. I doubt (after over twenty years as an auditor) if there is any pharmaceutical company that has not at some time had to abandon new programs or equipment for these reasons.
The FDA have actually stated that 70% of validation problems are directly related to none compliant procurement methods.
Your comments about you having to validate the equipment or program are completely erroneous. The end user has that task; your task is to ensure that your product is validatable. That means in all ways it must be compliant with the applicable directives in cGMP. On our site we carry further details of all these requirements.
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
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.