Is Annual Revalidation Required? ISO 13485 and FDA

M

MEDQA

#1
Is there a 13485, FDA or other requirement to re-validate equipment annually even if it has not been changed, modified, moved etc.?

We have an internal document that states as follows.

Re-val is required when Equipment is modified relocated or otherwise changed in a manner which may impact the process. In no changes are made to equipment they are re-validated annually.

This statement was added during a previous revision. I know the first sentence is required, but I am not sure about the annual requirement. I would like to revise it to say it will be reviewed annually to determine if Re-val is needed OR remove the 2nd sentence all together.

Equipment that requires calibration is required at least annually, but I'm not sure that was the intent of the 2nd sentence.

Thank you
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Re: Is Annual Revalidation Required?

This is from an FDA guidance

2. System to Assure Timely Revalidation
There should be a quality assurance system in place which requires revalidation whenever there are changes in packaging, formulation, equipment, or processes which could impact on product effectiveness or product characteristics, and whenever there are changes in product characteristics. Furthermore, when a change is made in raw material supplier, the manufacturer should consider subtle, potentially adverse differences in the raw material characteristics. A determination of adverse differences in raw material indicates a need to revalidate the process.

One way of detecting the kind of changes that should initiate revalidation is the use of tests and methods of analysis which are capable of measuring characteristics which may vary. Such tests and methods usually yield specific results which go beyond the mere pass/fail basis, thereby detecting variations within product and process specifications and allowing determination of whether a process is slipping out of control.

The quality assurance procedures should establish the circumstances under which revalidation is required. These may be based upon equipment, process, and product performance observed during the initial validation challenge studies. It is desirable to designate individuals who have the responsibility to review product, process, equipment and personnel changes to determine if and when evalidation is warranted.

*************************Original Page 13********************

The extent of revalidation will depend upon the nature of the changes and how they impact upon different aspects of production that had previously been validated. It may not be necessary to revalidate a process from scratch merely because a given circumstance has changed. However, it is important to carefully assess the nature of the change to determine potential ripple effects and what needs to be considered as part of revalidation

Link

hope that helps
 
M

MIREGMGR

#4
Re: Is Annual Revalidation Required?

Some critical-process standards include a requirement for re-validation at "defined intervals", and to require that those "intervals shall be justified". (Language from ISO 11135-1, EtO Sterilization.)

It is common in the US device industry to regard the outer limit for 11135 re-validation as three years, with a maximum interval of one year between justification analyses.

Other validation requirements do not mention periodic re-validation.

Thus, in answer to your question: it depends on the nature of the process and the applicable standard.
 
M

MEDQA

#5
We have Sterilization covered. Review annually and re-validate every 18 or 24 months (I forget which, but not more than 24 months).

Thanks for the help. It sounds like we can modify the document and still be compliant.

Any other comments or suggestions are appreciated.
 
M

MIREGMGR

#6
As you probably already have noted, ISO 11607-2:2006 says at 5.7.4 that "periodic revalidation or reviews should be considered...".

I would agree that you can remove the specific requirement for annual re-val. I'd replace it with an annual review.
 
M

MEDQA

#7
Great - :thanks:

I really appreciate the input. I'm kind of on my own when it comes to interpreting this things and it's not always easy to find a direct answer.
 

jkuil

Quite Involved in Discussions
#8
I comes down to the effectiveness of your change management procedure. If any change that affects the validated state of a process is identified through a rigid CM procedure, there is no need for revalidations. However, in real life we know that not all consequences of changes are identified properly. That is the purpose of an annual review: verify that the validated state is not compromised by any change that was not properly identified or evaluated.
Secondly, the monitoring an measurement of processes and product (ISO 13485 8.2.3 and 8.2.4) and the control of monitoring and measuring devices (ISO 13485 7.6) can identify changes in the validated state of processes and equipment. An effective monitoring and control system can justify that annual revalidations are not required. The data of the control and monitoring system serve as input for your annual review. And revalidation must be considered in our CAPAs.
 
D

Denis

#9
Good response Jan.

My usual answer to this question is - it depends.

It depends on a number of things - good in process monitoring checks can provide a wealth of feedback to support the re validation timelines.

A good Change Management procedure (and application) also support re validation and the subsequent risk analysis for decision making.

The problem I usually find with customer auditors, is that because they re validate every xx months, then they expect you to do the same.

I like to stress that there needs to be a rationale behind the re validation frequency, as opposed to a number of months.

It could be quite feasible to perform a re validation if changes to raw materials, personnel, engineering modifications have been made after a few months.
 
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