Comments on: Why Validation Projects Take So Long – Paperwork!

By: MANOHAR BHAGAVATULA

MANOHAR BHAGAVATULA — Sun, 26 Aug 2012 09:33:53 +0000

This completely resembled the computer validation environment i worked in . Infact, there are additional services provided by validation team to meet project timelines and to keep all the stakeholders together. These additional services are listed as below:
a) Assisting Business members in SOP identification that are applicable for updates.
b) Assisting Business members with Document Management System navigation for quicker reviews and approvals.
c) Assisting business team members for UAT preparation.
d) Assisting in creation of Work Instructions and User Manual.

All these tasks does not come under the direct purview of Validation team but in order to cross the toll gates together , these are deemed as essential activities.

By: Phyllis Fender

Phyllis Fender — Thu, 09 Aug 2012 00:30:24 +0000

Too funny. Also, sad but true. Let’s also not forget the times when the team informs you that “Oh, by the way, I know it’s Thursday but we bought a new machine that we want to install Saturday so Production can use it on Monday. Can we make it happen?” causing this entire process to be done in three days! Yikes!

By: Leonard Nduati

Leonard Nduati — Wed, 08 Aug 2012 06:14:36 +0000

You should come to the developing world, Africa. Here in kenya, in a pharmaceutical company of about 5o personnel, the CEO has no idea what validation is, the production manager is none the wiser, the QC manager is a green horn and these three are key personnel in validation work. So the QA manager generates a protocol and all the other fellows sign mechanically and immediately forget about it. Until inspectors come and they promptly disown the document. God help us!

By: Ahmed ali

Ahmed ali — Mon, 06 Aug 2012 20:59:02 +0000

Thanks, but you did not say any thing a bout IQ,OQ or PQ. Please inform me if this is necessary to include this issues in protocol and under what topic in validation.
Another question. Is it a must to do process validation for pharmaceutical product with different Lots of active ingredient for the 3 successive batches?

Thanks again
waiting your reply

By: Chris Burgoyne

Chris Burgoyne — Mon, 06 Aug 2012 20:13:59 +0000

This brings back painful memories. Especially Writing the Protocol. None of that stuff ever makes the project plan!

By: Rebecca Cook

Rebecca Cook — Mon, 06 Aug 2012 17:00:25 +0000

The article was a painfully accurate description of just one aspect of the validation process. Each of the supporting activities each present their own challenges of drafts/revision, review and approvals. But let’s not forget the additional challenges of working with an Subject Matter Expert (SME) with different work priorities than your own. If they are working on a critical project with a tight deadline or are facing resource contraints, they may not find the time to meet with you regarding the project.

In addition, the scope of the project may change, not once, but multiple times. The process may not fully fuctional at the time it is is submitted for validation, but may still be experiencing performance issues. Due to timeline contraints, the process/system is still scheduled for production. In this situation, the validator is developing documentation regarding a process that is still very fluid.