Requalification / Revalidation of Equipments and Instruments

sureshmpharm · May 24, 2011, 5:16am

Dear Forum,

I have some doubts regarding Requalification / Revalidation of Equipments and Instruments. Please clarify the below details:

What is the frequency for requalification / revalidation of equipments / instruments?

What are the parameters to be validated during requalification / revalidation?

Is there any regulatory guideline mentioning the frequency for Requalification / Revalidation?

Regards,

C. Suresh

yodon · May 24, 2011, 2:49pm

I can sum it up in 2 words: “You define.”

You define the frequency, the content, what’s included, etc.

Of course, your decisions have to be defensible. Clearly, a risk-based approach is preferred.

There are no regulations that I know of that define frequency. Again, a risk-based approach is recommended.

anil_saxena · May 24, 2011, 5:15pm

Dear member,

is it require to periodically perform installation and operational Re-qualification of Equipments and Instruments or only periodic performance qualification is sufficient?

Regards,

Anil

prasadraokilli · June 29, 2011, 5:02pm

What are the parameters to be validated during requalification / revalidation?

Dear sir,

In the requalification of the equipments, following checks to be done :-

1.Verification of safety features
2. critical parameters testing
3. Verifiication of motor performacne
4.Verification periodic monitering(any modifications done in equipment during the tenure)
5.Verification of preventive mantinance of the equipment of tenure
6.calibration for instruments of the equimpment.
7. SOP’s adequecy check
8. verification of major components of equipment.
9. verification of performance of the equipment(compile the data of minimum 5 batches which were taken on the equipment and the data shall compile the specification)

Regards,
Prasad

jyopravel · June 30, 2011, 4:16am

[quote=prasadraokilli]What are the parameters to be validated during requalification / revalidation?

Dear sir,

In the requalification of the equipments, following checks to be done :-

1.Verification of safety features
2. critical parameters testing
3. Verifiication of motor performacne
4.Verification periodic monitering(any modifications done in equipment during the tenure)
5.Verification of preventive mantinance of the equipment of tenure
6.calibration for instruments of the equimpment.
7. SOP’s adequecy check
8. verification of major components of equipment.
9. verification of performance of the equipment(compile the data of minimum 5 batches which were taken on the equipment and the data shall compile the specification)

Regards,
Prasad[/quote]

Dear Mr.Killi Prasada Rao

Equipment re-qualification not be completed with the above parameters. A scientific approach required for the same i.e. with risk assessment like FMEA tool

For existing equipment qualification APIC published a guideline, which provides the information clearly for re-qualification of equipments. For your reference it is attached with this post.

The following flow shall be followed during re-qualification of equipments

You should identify the list of equipments, which were due for re-qualification.
Prepare a protocol as per the attached guideline
Perform risk assessment for each equipment
Assess the data and prepare a qualification matrix
Prepare a documentation matrix as per review
Perform qualification as per qualification matrix
Update documents as per documentation matrix
Prepare a re qualification report and conclusion shall be drawn.

Find the APIC guideline

[attach]323[/attach]

Thanks and regards

Qualification_existing_equipment_final.pdf (224.5 KB)

jyopravel · June 30, 2011, 4:21am

[quote=anil saxena]Dear member,

is it require to periodically perform installation and operational Re-qualification of Equipments and Instruments or only periodic performance qualification is sufficient?

Regards,

Anil[/quote]

You can assess the IQ and OQ requirement as per risk approach [FMEA is preferred tool].

Thanks and regards

prasadraokilli · June 30, 2011, 6:35pm

Dear Prasad,

I am totally agree with you. the above mentioned points shall be prepared before the execution of Re-Qualificaton of an equipment and shall be mentioned VMP. but the points which i described was clearly mentioned in attached file APIC Guideline (Qualification of existing equipment final.pdf) in 5.3.2 table(Review of historical documents and production data) during Re-Qualificaion of an Equipment. Please check and revert…

Regards,
K.Prasad Rao

jyopravel · July 1, 2011, 3:53am

[quote=prasadraokilli]Dear Prasad,

I am totally agree with you. the above mentioned points shall be prepared before the execution of Re-Qualificaton of an equipment and shall be mentioned VMP. but the points which i described was clearly mentioned in attached file APIC Guideline (Qualification of existing equipment final.pdf) in 5.3.2 table(Review of historical documents and production data) during Re-Qualificaion of an Equipment. Please check and revert…

Regards,
K.Prasad Rao[/quote]

Dear Mr.Prasada Rao

Thanks for the reply, Please see my earlier post, I was not protested as you are wrong, I was stated as the mentioned data is not enough to complete the re qualification, some more extensive data required as per risk approach to fulfill the requirement.

Thanks and regards

prasadraokilli · July 1, 2011, 5:24pm

Dear Prasad,

I am sorry… I am totally agree with u and thanx for your valuable information and attached file.

Thanx and Regards,
Prasad

anvardeen2010 · July 19, 2011, 8:24am

HI ,

       I want some information on old equipment qualifications. we have purchased some equipments on 2005 , but we didn't perform qualifications on those equipments. Now we are planning for commercial production. As per the regulatory needs we should completed the qualifications for all critical equipments. 

      My question is how to do qualifications for old equipments. Whether we have to do it as retrospective method or some procedure. please guide me how to do first time qualifications for old equipments.  Please suggest the me the reference guideline for this situation.

gokeeffe · July 19, 2011, 8:37am

[quote=anvardeen2010]HI ,

       I want some information on old equipment qualifications. we have purchased some equipments on 2005 , but we didn't perform qualifications on those equipments. Now we are planning for commercial production. As per the regulatory needs we should completed the qualifications for all critical equipments. 

      My question is how to do qualifications for old equipments. Whether we have to do it as retrospective method or some procedure. please guide me how to do first time qualifications for old equipments.  Please suggest the me the reference guideline for this situation.[/quote]

First question I would ask is, do you have a set of requirements for these equipments?

anvardeen2010 · July 19, 2011, 9:16am

HI ,

         Did you mean , technical specification. We have some manuals.

gokeeffe · July 19, 2011, 9:19am

[quote=anvardeen2010]HI ,

         Did you mean , technical specification. We have some manuals.[/quote]

No I mean, what specifications did you use to buy the equipments in the first place.

I mean the starting point would be a User Requirement Document.

If you don’t have one of these you would need to justify in a validation plan the steps you

are going to take to retrospectively validate the equipment.

anvardeen2010 · July 19, 2011, 9:25am

HI ,

       Thanks for your comment. do u have skype id , we will discuss biref in chat. This is my id anvardeen2015