FDA Hardening of Autoclave Test Procedures.
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.
A documented rationale must be included justifying the number and
position of the temperature censors to be used.
A drawing showing their location and identity must be produced and
appended to the temperature mapping documentation.
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.
Please click here and let us know of any purchasing problems.
Free Validation Document Downloads.
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
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?
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.
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
Purchase your copy of this test script now at Special Price of