820.40 Document controls.

The whole points of this section ‘Document Controls” are nobody can simply revise and approve any procedure and documents. All new revision of procedures, documents, protocol, manufacturing processes must be well thought of and be implemented effectively throughout the whole organization.    Associates whom have been effectively trained on the documents can perform a task according to the procedure.

Each stage of a document must be indicated as either ‘DRAFT’, ‘Controlled’ or OBSOLETE’. Only approved documents can be used. Effective date of each document must be conspicuously shown on the document or the effective date is easily accessible. It is not uncommon for careless associate to work on the old revision of a procedure resulting in a messy deviation.  This obsolete document must be marked ‘OBSOLETE” and be removed promptly from being inadvertently used.

Any change to each document must be performed according to corporate procedure. It is critical to get all related departments managers involved to ensure the change can be reviewed, edit, approved and implemented.

A sponsor should have a document control department to ensure all new documents are initiated, edited and written properly and present documents revised accordingly. There should not be any obsolete document floating around.  

The table below is the exact working from FDA website.

Sec. 820.40 Document controls.
Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:
(a)Document approval and distribution	Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.
(b)Document changes.	Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.

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