Pharmaceutical Company Quality Manual

[dehnad2001]

Dear All,
Encosed is the quality manual I have written for a pharmaceutical company in the field of chemotherapetical products, I need your feedbacks!
I also attach the process map and quality policy statements as two appendixes of this manual.
Thanking you in advance.

[Jennifer Kirley]

I'm used to seeing actual definitions in the Definition section instead of as footnotes.

You can leave out phrases like "in compliance with ISO 9000:2005" and just write that which complies.

I understand you are still adding things like procedure numbers in 8-5-3 and 1. Company history?

Any other comments out there?

[BradM]

Hello!

A couple of things I noticed. Not sure if 21CFR11, regarding electronic records/signature (electronic records) is an issue with your regulatory body. If you do, that may need to be addressed. You may address that in your lower level validation procedures; I'm not sure.

3.2, where you have a statement of inserting relevant industry requirements, seems to be a very broad and comprehensive statement. Do you need to have that there (do you want to try to accomplish that there?) You seem to have addressed most of the referenced requirements throughout your policy (validation, GMP, calibration, records, etc.)

What about Good Documentation Practices? Is that addressed?

Just some things I saw.

[Jim Wynne]

Originally Posted by dehnad2001

Dear All,
Encosed is the quality manual I have written for a pharmaceutical company in the field of chemotherapetical products, I need your feedbacks!
I also attach the process map and quality policy statements as two appendixes of this manual.
Thanking you in advance.

It's awfully wordy. Have a look at the attachment--I cut your first page just about in half without losing anything meaningful.

[dehnad2001]

Hello,
Many thanks for your post. I am going to add some information in company history (about the parent company, factory and head office address, products and other relevant information in that section), references (adding pharmaceutical reference docs.), scope (including product forms and their general categories) and also mentioning documents codes.

[dehnad2001]

Many Thanks BradM,
In 3.2 I will add specific regulatory refernces (as you mentioned that part is not completed yet).
Regarding electronic signatures, the details will be mentioned in va;idation protocols.
I don't understand what do you mean by documentation practices, could you describe more?
Thanks,