Quality Control Personnel (Part F) cGMP SOP Templates and Supporting Documents

Quality Control Personnel (Part F) cGMP SOP Templates and Supporting Documents

Batch Disposition (SOP and Form)

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This SOP establishes procedures for the approval or rejection of product batches manufactured or retail packaged.

Calibration Failures (SOP, Report and Log)

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This SOP, report and report log establishes procedures and provides resources to document and investigate calibration failures as required by 21 CFR 111.

Planned Deviations (SOP, Report and Log)

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This SOP, report and report log establish procedures and documentation for deviations from instructions provided in the Master Manufacturing Record, standard operating procedures, or other specification documents, with the deviations being temporary and approved in advance by quality assurance (QA) and other management

Out of Specification Investigation (SOP, Report and Log)

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This SOP, report template and log establish procedures and documentation for investigating out-of-specification (OOS) test results, to determine whether the OOS result is an accurate reflection of the lot or batch (i.e., is a valid test result) or is a result of laboratory or sampling error (i.e., is an invalid test result).

Reportable Foods (SOP, Report and Log)

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This SOP establishes procedures for reporting certain kinds of foods to FDA. A reportable food report template and report log are also provided.

Nonconforming Materials (SOP, Report and Log)

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This SOP, report and report log establish procedures for documenting the review and disposition of materials which are either in process or in inventory and are found to be nonconforming, i.e. which fail to meet established specifications for identity, purity, composition, or quality or which are otherwise unsuitable for use (e.g. contaminated)

Corrective and Preventive Actions (SOP, Report and Log)

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This SOP, report template and log establishes procedures and documentation for corrective and preventive actions that are NOT related to specific lot(s) or batch(es) of production material.

Production Failure Investigations (SOP, Report and Log)

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This SOP establishes procedures for documenting and investigating production failures. An investigation production failure report template and report log are also provided.

Unplanned Deviations (SOP, Report and Log)

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This SOP establishes procedures for documenting unexpected occurrences and unplanned deviations from the instructions provided in the Master Manufacturing Record, standard operating procedures, or other specification documents. An unplanned deviations report and report log are also provided.

General Calibration Procedures (SOP and Log)

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This SOP and log can be used to set and document procedures for general calibration.

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