MFR of Nimesulide 100 mg and Paracetamol 325 mg Tablets TABLE OF CONTENTS S.NO. TITLE Page No 1.0 PRODUCT DETAILS 2.0 MANUFACTURING FORMULA 3.0 LIST OF EQUIPMENTS 4.0 MANUFACTURING INSTRUCTIONS 5.0 GENERAL PRECAUTIONS 6.0 MANUFACTURING PROCESS DETAILS 6.1 GRANULATION 6.2 COMPRESSION 1.0 PRODUCT DETAILS: Product Name Nimesulide and Paracetamol Tablets Product Description…
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STANDARD OPERATING PROCEDURE Title: Procedure For handling of returned goods OBJECTIVE To lay down a procedure for handling of returned goods. SCOPE This procedure is applicable for handling the retuned goods. RESPONSIBILITY Manager-Quality Control Manager-Warehouse ACCOUNTABILITY Manager-Quality Assurance PROCEDURE Returned goods in general belongs to: Recalled product in-case of product recall. Returned saleable finished goods….
STANDARD OPERATING PROCEDURE Title : Procedure For line clearance activities during processing of product OBJECTIVE To lay down the procedure for Line Clearance. SCOPE This procedure is applicable for line clearance activities during processing of product. RESPONSIBILITY Officer-Production Officer-IPQA/QA ACCOUNTABILITY Manager-Production Manager-Quality Assurance PROCEDURE Officer-Production should place the line clearance status board after ensuring the…
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STANDARD OPERATING PROCEDURE Title : Procedure For Internal Facility Audit Department : Quality Assurance OBJECTIVE To lay down the procedure for carrying out Self Inspection of various departments. SCOPE This procedure is applicable for carrying out the self inspection of all departments. RESPONSIBILITY It is a joint responsibility of all self-inspection team members in…
STANDARD OPERATING PROCEDURE Title : Procedure For Good Documentation Practices Department : Quality Assurance OBJECTIVE To lay down a procedure for good documentation practices. SCOPE This procedure is applicable for all Production, Quality Control, Quality Assurance, Warehouse, Engineering & utility and Personnel and Administration departments. RESPONSIBILITY Officer/Executive-QA. ACCOUNTABILITY Manager-Quality Assurance PROCEDURE Design and Preparation…
STANDARD OPERATING PROCEDURE Title : Procedure for Surface Monitoring of Equipment by Swab Department : Quality Control-Microbiology OBJECTIVE To lay down a procedure for surface monitoring of equipment by swab. SCOPE This SOP is applicable for surface monitoring of equipment by swab in microbiology laboratory. RESPONSIBILITY Officer / Executive-QCM – responsible for Implementation of…
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STANDARD OPERATING PROCEDURE Title :Procedure for handling of cultures & contaminated material Department:Quality Control-Microbiology OBJECTIVE To lay down a procedure for handling of cultures & contaminated material. SCOPE This SOP is applicable for handling of cultures & contaminated material in microbiology laboratory . RESPONSIBILITY Officer / Executive- QC M – responsible for Implementation of SOP….
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MFR of Pantoprazole Sodium 40 mg and Domperidone 10 mg Tablets in Pharma Industry TABLE OF CONTENTS S.NO. TITLE Page No 1.0 PRODUCT DETAILS 2.0 MANUFACTURING FORMULA 3.0 LIST OF EQUIPMENTS 4.0 MANUFACTURING INSTRUCTIONS 5.0 GENERAL PRECAUTIONS 6.0 MANUFACTURING PROCESS DETAILS 6.1 GRANULATION 6.2 COMPRESSION 1.0 PRODUCT DETAILS: Product Name Pantoprazole Sodium…
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STANDARD OPERATING PROCEDURE Title : Procedure for preparation of disinfectant & cleaning of microbiology laboratory OBJECTIVE To lay down a procedure for preparation of disinfectant & cleaning of microbiology laboratory. SCOPE This SOP is applicable for disinfectant & cleaning of microbiology laboratory. RESPONSIBILITY Officer / Executive-QCM – responsible for Implementation of SOP. ACCOUNTABILITY Manager…
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Code to Code Transfer of Materials and Additional Testing of Materials / Products in Pharma Industry Objective To lay down a procedure for code transfer of same material from one code to another and to carry out additional testing of APIs, Excipients and Drug Products to comply with other specifications or Pharmacopoeia. Scope This standard…
