The Ultimate Resource for Pharmaceutical SOPs and Best Practices
A minor revision refers to a change that does not alter the intent, process flow, or critical steps of the SOP. These changes are typically administrative or formatting-related.
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Each SOP must include a change history table on the front page or in an annex. This table summarizes each revision with key details such as:
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Document control becomes increasingly complex when dealing with:
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Before communicating the revised SOP, list all personnel impacted by the change. This includes:
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First, determine the nature of the revision:
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Each change log entry must begin by referencing the SOP it belongs to. This includes:
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Clearly establish what constitutes an obsolete SOP in your Quality Manual or Documentation SOP. Typically, this includes any controlled document superseded by a new version or rendered unnecessary due to process changes.
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Regulators such as the USFDA often review how companies handle changes to controlled documents. Failures in SOP revision processes are among the top findings in regulatory inspections. This includes:
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Begin with a corporate quality policy that mandates harmonization. This should define overarching principles that every site must adhere to, including how SOPs are developed, revised, approved, and implemented.
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Change control ensures that any modification made to a GxP-controlled document such as an SOP is:
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