FDA Requirements for Document Approval by Quality Department

[Ajit Basrur]

Hi,

With reference to FDA, have heard many times that there should be Quality approval for all documents that impact the quality systems. Can anyone let me know where is it mentioned that the Quality personnel should be the final approver of documents ?

[Wes Bucey]

Originally Posted by Qualityalways

Hi,

With reference to FDA, have heard many times that there should be Quality approval for all documents that impact the quality systems. Can anyone let me know where is it mentioned that the Quality personnel should be the final approver of documents ?

No one says FINAL approval, merely "approval."

Typically, in many larger companies, Quality department is only one of several signoffs, ALL of which are required before FINAL approval is bestowed and implementation allowed.

The original concept of multiple signoffs was to bring a multi-disciplinary approach to each new or revised version, but, alas, too often, the group of signers neglect real review and merely rubber stamp the documents, resulting in egregious errors.

[Cari Spears]

Originally Posted by Qualityalways

... have heard many times ...

Heard from whom?

[ScottK]

(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.

From 21 CFR part 211.22

As Wes said - this doesn't specify "final".

[Ajit Basrur]

Heard from various people working in Pharmaceutical industry and also seen on documents which had Quality approval as a last signatory. In my all past work experiences in various multinational Pharmaceuticals, we had documentation requirements which had spelt Quality approvals to be taken as last but I could not get any reference to this requirement.

[Ajit Basrur]

Thanks Discordian

[Wes Bucey]

Actually, as far as FDA is concerned, it isn't "approval" so much as "veto power." Veto power (another term for "empowerment") is something the best run companies are very liberal in spreading around. All would rather err on the side of caution than create life, health, safety issues.