SOP ON HANDLING OF OUT OF SPECIFICATION (OOS)

SOP ON HANDLING OF OUT OF SPECIFICATION (OOS) WITH ATTACHMENTS

• Attachment-I: Format of Log Book for  Out of Specification
• Attachment II: Format for Out of Specification (OOS) Report.
• Attachment-III: Extension for OOS Record No
• Attachment-IV: Format of Periodic Trend of OOS
• Attachment-V: Format for Assessment of developing trends.
• Attachment-VI: Format for Intimation of OOS to Purchase Department
• Attachment-VII: Flow chart for Laboratory Investigation
• Attachment-VIII: Flow chart for Phase I an Investigation
• Attachment-IX: Flow chart for Phase I b Investigation
• Attachment-X: Flow chart for Phase II Investigation
• Attachment-XI: Flow chart for Phase II (Conducting Laboratory Failure Investigation)
• Attachment-XII: Flow chart for Phase II (No Assignable Cause)
• Attachment-XIII: Flow chart for Phase III investigation

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