Good Documentation Practices, also known as GDocP, is an important function of Good Manufacturing Practices (GMPs.) As the saying goes, āIf it isnāt written down, it didnāt happen.
Most 483 observations cite companies for not recording information properly, not following whatās written or not establishing a procedure to follow.
Our Quarterly Special Report QSR-22Q1, issued February 15th, details multiple instances where companies have been cited for documentation issues. This report shows documentation issues happen in all aspects of the pharmaceutical and medical device manufacturing, testing, packaging, and distribution. For example:
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Creation, Approval, Distribution, Maintenance and Storage of Standard Operating Procedures.
A company was cited for:
ā¦.. The responsibilities and procedures applicable to the quality control unit are not fully followed. {21 CFR 211.22(d)}
Specifically, during review of documents, discrepancies were noted between various documents and their associated procedures, including but not limited to the following:
SOP…, āDocument Controlā, states that āeach department is responsible for updating procedures as changes occur in their work areaā; also states āEach approval is targeted to be complete within … of the Issue/Revision, but may be deviated from due to extenuating circumstancesā; also states āThe Quality Supervisor will check that all necessary approvals are signed and datedā: and also states āUsing the Document Control spreadsheet (…) as a reference, the Quality Supervisor and/or the Regulatory Control Coordinator (acting) ensures only current documents are in circulationā; and states āPeriodic auditing should be performed to verify that only the current approved revisions are being utilized and to indicate any minor changes that should be made with subsequent revisionsā, in comparing various documents to the requirements in this procedure, the following were noted:
a. Various examples of obsolete documents are still in circulation, including obsolete procedures which are no longer in use due to equipment changes.
b. New draft procedure being completed, and subsequently not receiving final sign off and implementation for no specific reason. For example, SOP… was to be revised to include a requirement for … auditing/review of documents. However, as of 3 months later the draft procedure for SOP … had still not been implemented.
The best place to start is to have your procedures set up properly. Check out our free download on how to set up standard operating procedures called, āCreation, Approval, Distribution, Maintenance and Storage of Standard Operating Procedures.ā
For more information on documentation practices refer to WHO guidance document, WHO Guidance on good data and record management practices.
To view more observations pertaining to documentation, refer to the following GMP TrendsĀ® Issues: 1082, 1079, 1078, and 1077.
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