DEVIATION FORM FILLING IN PHARMA(

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primary purpose of a deviation investigation report in a GMP environment is to clearly and concisely demonstrate that the root cause of the deviation has been identified; corrective actions have been taken; and that safety, integrity, strength (potency), purity, and quality (SISPQ) of the product has been ensured.
The investigation report should house the details of the investigation in a manner that provides appropriate level of background and ensures the level of investigation is thorough and commensurate with level of risk. To achieve these objectives, an investigation report is recommended to contain the following sections:
1. Executive Summary
1.1 Deviation event
1.2 Root cause
1.3 Product impact
1.4 CAPAs
2. Process or equipment overview
3. Deviation event description
4. History review
5. Root cause investigation
6. Product impact assessment
7. Corrective actions.
Executive summary
The executive summary is the most visible section of the deviation investigation report. A well-written executive summary is one that satisfies the reader (e.g., regulatory agency inspector) by presenting a complete and concise synopsis of the deviation investigation. To achieve this, the executive summary should contain the following subsections:
Deviation event: Two to four introductory sentences describing the deviation. Although the deviation event itself will likely be already know to the reader, the event should be restated such that the investigation report and the executive summary may serve as stand-alone documents during the inspection.
Root cause: Subsection begins with “The most probable root cause of deviation # is ….” followed by the concluding statement taken directly from Root Cause Investigation section (described below). It must be made clear to the reader that a formal investigation tool was used to arrive at the most probable root cause.
Product impact: This subsection clearly and concisely repeats the product impact concluding statement taken directly from Product Impact Assessment section (described in the following). If no product impact has been confirmed, then this section should state at that onset “There is no expected product impact resulting from this deviation as confirmed by … (e.g., quality attribute testing, in-process controls, quality risk assessment, etc.)”
Corrective actions: This subsection begins with “The following CAPAs [corrective actions and preventive actions] have been implemented to address the root cause of this deviation,” followed by a bulleted list of the CAPAs and/or change controls. Regulatory agencies will expect corrective actions be taken in response to deviations, so a strong emphasis should be made by the manufacturer to demonstrate that a proactive approach has been undertaken to correct the deviation root cause. (‪@PharmaScholars‬ )