SOP For Root Cause Analysis

1.0 OBJECTIVE:   To lay down the procedure and guidance for conducting investigation of various non-conformities at manufacturing site to identified the root cause and recommend the correction and preventive action. 2.0 SCOPE:   The…

Good Documentation Practices

  OBJECTIVE: To lay down a procedure to describe the steps to be followed for good documentation practices; and ensure that each personnel receives clear and detailed description of the relevant job assignment to minimize…

SOP FOR Batch Reconciliation

OBJECTIVE: To lay down a standard procedure to describe the steps to be followed for stage-wise yield calculation and final batch reconciliation. SCOPE: This SOP is applicable to following dosage forms: Tablets Hard Gelatin Capsules…