I am currently working for a pharmaceutical company that has a document control department and system in place. My background is more ISO 9000/13485 So I have extensive experience with these systems. I can not find any reference to actual control of documents within CFR 21 Part 210 or 211.

Is there any one who can help me with this, people are reciting all sorts of numbers that are guidance for completing, review etc but not control.

thanks

21 CFR Part 820.40, Subpart D covers document controls.

First off, welcome to the Cove, jfount! :bigwave:

I admit that I'm not familiar with CFR 21, but aren't the methods of completing, reviewing, etc. all part of the process of document control?

I can not remember them all but just a quick scan I came up with this.
211.100 Written procedures
211.130 Labels procedures
211.180 and following lists many of the records required.

I do not know specifically if/where document control is listed in the CFR.

Mark

Thanks everyone for the quick responses, but GMPs for Pharma are CFR 210 and 211. Although they refer to documents, they don't refer to controlling them.
My best guess is it's a gimme. (Document Control) It's assumed in order to have these documents available for review they must be controlled?

If anyone has a direct answer to my original question it would be greatly appreciated.
Thanks again

I don't think that document control is specifically covered by 210/211, though sections relevent documents are 211.180, 211.182, 211.184, 211.186, 211.188, 211.194, 211.194,211.196 and 211.196.

If you are looking for general cGMP guidance on documentation the EU gmp guide may be of use.

ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htp

(I can't post links yet)

See 21cfr211.100Sec. 211.100 Written procedures; deviations.


(a) There shall be written procedures for production and process
control designed to assure that the drug products have the identity,
strength, quality, and purity they purport or are represented to
possess. Such procedures shall include all requirements in this subpart.
These written procedures, including any changes, shall be drafted,
reviewed, and approved by the appropriate organizational units and
reviewed and approved by the quality control unit.
(b) Written production and process control procedures shall be
followed in the execution of the various production and process control
functions and shall be documented at the time of performance. Any
deviation from the written procedures shall be recorded and justified.