FDA Hardening of Autoclave Testing Procedures
Several recent FDA warning letters have included what appears to be a hardening of requirements in autoclave validation. I deliberately use the term ‘hardening’, because these requirements have been know about; but usually considered as desirable rather than essential. As such, minimal effort has been exerted into ensuring they were clear and concise. The warning letters gave loud and clear warning that these two subjects must be included in your temperature mapping of autoclaves.
1) A documented rationale must be included justifying the number and position of the temperature censors to be used.
2) A drawing showing their location and identity must be produced and appended to the temperature mapping documentation.
This initially will give many companies problems, however all autoclaves go through exhaustive testing by the original manufacturer at their manufacturing plant. This testing is normally included in the FAT (Factory Acceptance Testing). Along with this your initial IQ (Installation Qualification) is intended to show that your installation has not adultered the equilibrium of the design heat flow requirements that were confirmed in the execution of the FAT. Therefore I would suggest that you contact the relevant people and obtain the documented verification for these two parameters.
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.