MFR of Paracetamol Oral Suspension IP (125 mg)

MFR of Paracetamol Oral Suspension IP (125 mg) TABLE OF CONTENTS SNO. TITLE Page No 1.0 PRODUCT DETAILS 2.0 MANUFACTURING FORMULA 3.0 LIST OF EQUIPMENT 4.0 GENERAL PRECAUTIONS 5.0 MANUFACTURING INSTRUCTIONS 6.0 MANUFACTURING PROCEDURE 7.0 FILLING AND PRIMARY PACKING DETAILS 8.0 SECONDARY AND TERTIARY PACKING PROCEDURE 9.0 FINISHED PRODUCT SAMPLING & ANALYSIS 10.0 SHIPPER STRIPING … Read more

Un-Planned Deviation & Incident Example – II

Un-Planned Deviation Example Investigation Details for Incident No.:____________________________________ 1.0       Product details Name of product B. No. B. Size Batch stage Granulation (Lubrication) Investigation team member details Production Supervisor IPQA Production Manager QC Head Warehouse In Charge QA Head Incident details Lubricated granules of the batch containing API (Clobazam) and excipients (MCCP PH 102, Cross … Read more

Un-Planned Deviation Example – I

  Un-Planned Deviation Deviation Investigation Report Description of Deviation: The document entry of dispensing and cleaning records is not recorded by the respective operators. Type of deviation:  Un-Planned Deviation Class of Deviation:  Minor Date of investigation:   Department:  Warehouse Date of deviation Observed:   Investigations start date:   Investigation completion date:  INVESTIGATION TEAM S.No. Name Designation Department 1. … Read more