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…