Do you have good documentation practices?

Good Documentation Practices, also known as GDocP, is an important function of Good Manufacturing Practices (GMPs.)  As the saying goes, “If it isn’t written down, it didn’t happen.

Most 483 observations cite companies for not recording information properly, not following what’s written or not establishing a procedure to follow.

Our Quarterly Special Report QSR-22Q1, issued February 15^th, 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:

A company was cited for:

….. 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…, “Document Control”, states that “each department is responsible for updating procedures as changes occur in their work area”; also states “Each approval is targeted to be complete within … of the Issue/Revision, but may be deviated from due to extenuating circumstances”; also states “The Quality Supervisor will check that all necessary approvals are signed and dated”: and also states “Using the Document Control spreadsheet (…) as a reference, the Quality Supervisor and/or the Regulatory Control Coordinator (acting) ensures only current documents are in circulation”; and states “Periodic 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 revisions”, 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, “Creation, Approval, Distribution, Maintenance and Storage of Standard Operating Procedures.”

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 Trends® Issues:  1082, 1079, 1078, and 1077.

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