Line Clearance Procedure

Hello There,

I am working on a line clearance procedure for a large volume Injection (IV bags). The line includes compounding, filling, sterilization and packaging. What should I include in this procedure in order for it to be compliant with the European GMP???

Can someone please help me and any possible examples are highly appreciated.


This question is also posted on Linkedin by our moderator and my good friend Mr.Graham.

What you should do is look into your Self Inspection procedures which are equal to Line clearance procedures.

You need to chart down each of your operations into Units and chalk down what in-process controls you have and what are the shortfalls you have.
If you can identify those GAPs and put control procedures as in-process checks and then start documenting these as a part of your QA inspectional procedures during batch progress.

To support my statements and give you further information, 'am hereby enclosing a presentation from Irish Medicine Board on such self inspections and EU GMP requirements.

What WHO says?

presentation attached.

Self inspections.pdf (398.7 KB)