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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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.