Documentation required from commissioning to Qualification

TEMPLATES & PRESENTATIONS
1

Dear All,

I want one clarification from the forum that suppose if anybody wants to build a sterile manufacring facility , from which stage QA/validation will come into the picture
a. Before finalization of area layout
b. Before civil work
c. After civil wark and before finalization of Equipment vender

what is basis for that and what document required for that.

Regrds
Himanshu C

2

Validation is part of the system life cycle and needs to be involved as early as possible on any project. On a Sterile Manufacturing Facility a Validation Master Plan would be necessary. From that you have a Commissioning and Qualification Plan.

3

Dear RR

Can you please elaborate the commissioning plan what should be contents of its and how it will differ with VMP.
Regrds
Himanshu

4

Himanshub

See if you can get a copy of the ISPE Commissioning and Qualification Baseline Guide , GAMP 5 and ASTM E2500 standard. These all will help you.

The Commissioning Plan should define the facilities, systems and equipment based on system boundries.Commissioning can be used to support validation and qualification. The Validation Master Plan is the High Level document to show the overall qualification approach. It includes the strategy for commissioning and qualification, system impact assessment, outline the documentation requirements, and outline the relationship and interdependency of commissioning and qualification. Then the commissioning plan details specifics for the commissioning.

And get involved early in the project. The Plans should be written early enough to take advantage of Factory Acceptance Tests (FAT) and well before the facility is constructed.

5

Thanks RR ,

Can u please share these apex documents to me if possible my mail id is (himanshumb@sify.com).

Regards
Himanshu

6

Himanshu

I will send you the ASTM standard E2500. You will have to purchase the GAMP 5 and the Baseline Guide for Commissioning and Qualification as they are printed books and I do not have them electronically. You can get them at

ASTM Standard for C Q E2500.pdf (76.2 KB)

7

Thanks RR.

Regrds
himanshu