What makes a successful validation project?

GOOD VALIDATION PRACTICE (cGVP)
1

Hi All,

I would be interested to hear what in your opinion makes a successful validation project.

I’ll get the ball rolling.

  • Validation Policies
  • Validation Guidelines
  • Validation Plans
  • Procedural Controls
  • Compliance Assessments
  • Supplier Qualification/Auditing
  • Project Schedule
  • Project Team
  • Review System
  • Training
  • Timelines
  • Project Manager

Please add to the list with your experience.

Regards

2

Good list… I would add Document Control and Materials Control. Also, not too sure how to say it - maybe you’ve already covered it in Procedural Controls - but control of the test equipment; e.g., balances, thermometers, etc.

3

Thanks yodon,

Also dedicated support from vendors, espcially for retrospective validation where documents are required from the vendors.

4

Dry run of validation protocols before execution - this will reduce the number of deviations at real execution time

5

Hi,

i would add Risk Analaysis plan for the company as well as Risk Assessments for systems under use. Also at end of project, a traceability matrix linking various validation documents is quite useful, more so for SAP Validation type of projects involving large numbers of documents.

6

I like to Add “Change Control Management” into the list. While carrying out the validation project, changes take place at all level.

Hence it is necessary for the execution of the validation project

7

Dear all,
Can anyone help me providing training module of process validation.

Best wishes,
Md Tarique Nasim
Sr. Asst. Manager, Validation
Beximco Pharma

[quote=Vijayakumar Babu]I like to Add “Change Control Management” into the list. While carrying out the validation project, changes take place at all level.

Hence it is necessary for the execution of the validation project[/quote]

8

[quote=Md Tarique Nasim]Dear all,
Can anyone help me providing training module of process validation.
[/quote]

What type of process validation are you talking about?

9

I would say adequate trained resources. A detailed complete engineering turn over package. Commissioning - documented, successful, and thorough. Clear acceptance criteria and requirements.