FDA Hardening of Autoclave Test 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.
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Free Validation Document Downloads.
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.
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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 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.