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Template Variables

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Subject Line:

Body:

To: Head of Quality Assurance
From: Production Department

SUBJECT: Application for Planned Deviation

Product Name: {{PRODUCT_NAME}}
Batch Number: {{BATCH_NUMBER}}
Batch Size: {{BATCH_SIZE}}
Manufacturing Stage: {{MANUFACTURING_STAGE}}

Description of Planned Deviation:
{{DEVIATION_DESCRIPTION}}

Reason / Justification for Deviation:
{{JUSTIFICATION}}

Impact Assessment on Product Quality/Efficacy:
As per our preliminary assessment, this deviation does not impact the critical quality attributes (CQAs) of the product because {{IMPACT_REASONING}}.

Proposed Corrective Action:
{{CORRECTIVE_ACTION}}

Requested By: 
{{REQUESTOR_NAME}}, Production Executive
Date: {{CURRENT_DATE}}

--- FOR QA USE ONLY ---
Received By QA: [   ]
Risk Assessment Required: [ Yes / No ]
QA Remarks: