Where to draw the line with Red Lining?

[jscholen]

I was looking for others experience with Red Lining with regard to how the FDA looks at it.

How much is too much?

Where and when it is not appropriate?

Thanks.

Jeff

[BradM]

Hello Jeff! Welcome to the Cove!

What documents are you wanting to red-line?

[Ajit Basrur]

Hi,

I have moved the thread to this section to attract more responses. Btw, Jeff can you provide more details on your question ?

[jscholen]

Hey Thanks for taking my questions:

I would like to redline in-process manufacturing documents for clinical product builds(mistakes were made in creating released documents) and commerical product builds(mistakes were made in creating released documents) and product needs to get out the door?

Does this give enough info?

Jeff

[ScottK]

Originally Posted by jscholen

Hey Thanks for taking my questions:

I would like to redline in-process manufacturing documents for clinical product builds(mistakes were made in creating released documents) and commerical product builds(mistakes were made in creating released documents) and product needs to get out the door?

Does this give enough info?

Jeff

Is the process defined? If it's not and anyone can red line a document and approve it then I would guess the FDA would take issue.
If the process is defined with proper authorities and consistently followed then it'll be far easier to defend.

however - I would (have in non-FDA regulared companies) taken an approach of making the document revision process faster so there is no real need for red-lined documents.

[jscholen]

Originally Posted by ScottK

Is the process defined? If it's not and anyone can red line a document and approve it then I would guess the FDA would take issue.
If the process is defined with proper authorities and consistently followed then it'll be far easier to defend.

If you mean the process is defined by procedures and documentation, then yes....

What I am trying to understand is if there is a general feel for how much redlining is too much...meaning someone (investigator or auditor) could come in and state that too much redlining indicates that the process was not well defined to begin with and therefore out of compliance. Looking for a threshold, but maybe my question indicates a very subjective call.

[yodon]

The FDA is going to look to see if you are in control of your processes. That means that everyone knows what to do, where to find things, what's right, etc. If you have a process that says you can redline a released procedure, the process is followed (in terms of documenting the change), and everyone follows the changes, then you should be in a defensible position. If, somehow, someone didn't get the redlines, didn't know, or didn't follow the changes, then you will be dinged.

Generally, I've observed that redlines indicate to the inspectors a *potential* for lack of control (where there's smoke...). They are generally a trigger for the inspector to look deeper. If you're bulletproof then don't worry. If not...

[Phil Fields]

We allow Red Lining to occur, but it is controlled with a Permit Process. A permit is documented by the Manufacturing Quality Manager, then review and signed off by Mfg Eng, Product Eng and Quality. This permit kicks off the engineering change process.
Our documentation and EPR system is flagged to indicate that a permit has been authorized for the part.

Phil