cGMP SOP Template and Example Attachment

General and Example cGMP SOP Templates and Supporting Documents

cGMP SOP Template and Example Attachment

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Published: Thursday, April 1, 2010

This template provides one possible format for cGMP Standard Operating Procedures (SOPs). Many variations are possible. Each Company should adopt a format suitable for their operations. When using the template, change the watermark “Draft” to “Approved” after the document is finalized and approved; or else develop a different way to clearly identify the status of each document, whether circulated in electronic or hard copy form. With respect to the approval signatures, these should be obtained from management of each department affected by or responsible for any part of the SOP, as well as QA.  Approvals may be signed on each page of the document, or only on the first page, depending on the company’s procedures.

A template form for recording equipment calibration is also provided. It is critical that calibration records include (or allow reference to other documentation which includes) the following (see 21 CFR §111.35): The equipment calibrated; the date of calibration; the reference standards used for calibration; the accuracy and calibration history of the standards; the calibration method used; the allowed limits for accuracy and precision; the readings found; any recalibration methods and readings; the initials of the person performing the calibration and/or recalibration. In the event that a piece of equipment fails calibration, there may need to be an investigation as per 21 CFR §111.113(a)(4). Any recalibration or repair of the affected equipment may be documented as a Corrective and Preventive Action (CAPA). Reference to the investigation report number and/or CAPA report number can be made in the right-hand column of the log.] 

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