PREPARATION AND REVIEW PROCEDURE OF ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR)

PREPARATION AND REVIEW PROCEDURE OF ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR) WITH ATTACHMENTS

• Attachment-I: Template for Annual Product Quality Review.
• Attachment II: Methodology for calculation of statistical control limit.
• Attachment-III:Methodology for calculation of OOT for stability.

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