Preparation of Master Formula Record MFR

  Preparation of Master Formula Record (MFR)   1.0 Objective 1.1 To describe he procedure for preparation of Master Formula Record. 2.0 Purpose and Scope 2.1 This SOP applies to the preparation of Master Formula Record. 3.0 Responsibilities 3.1 Primary Responsibility: F&D and Production Department. 3.2 Secondary Responsibility; Quality Assurance Department. 4.0 Accountability 4.1 Head- … Read more

Receipt of Excess RM/PM from Production

  Receipt of Excess RM/PM from Production   1.0 Objective To lay down a procedure for receipt of excess RM/PM from production. 2.0 Scope This Standard Operating Procedure is applicable for receipt of excess RM/PM from production to be followed at formulation plants of abc company. 3.0 Responsibility 3.1 Officer/Executive warehouse shall be responsible for … Read more

sop for Receipt of Returned Goods from Market

sop for Receipt of Returned Goods from Market   1.0 Objective To lay down a procedure for receipt of returned goods from market. 2.0 Scope This Standard Operating Procedure is applicable for receipt of returned goods from market to be followed at formulation plants of abc company. 3.0 Responsibility 3.1 Warehouse Officer / Executive shall … Read more

sop for Verification of Weighing Balance

  sop for Verification of Weighing Balance   1.0 Objective To lay down a procedure for verification of weighing balances in warehouse. 2.0 Scope This Standard Operating Procedure is applicable for verification of weighing balances in warehouse to be followed at formulation plants of a b c company. 3.0 Responsibility 3.1 Officer / Executive warehouse … Read more

sop for Dispensing of Raw Material

  sop for Dispensing of Raw Material   1.0 Objective To lay down a procedure for dispensing of raw material. 2.0 Scope This Standard Operating Procedure is applicable for dispensing of raw material to be followed at formulation plants of A B C Company. 3.0 Responsibility 3.1 Officer / Executive warehouse shall be responsible for … Read more

sop for Storage of Standard Weights

  sop for Storage of Standard Weights   1.0 Objective To lay down a procedure for storage of standard weights. 2.0 Scope This Standard Operating Procedure is applicable for storage of standard weights to be followed at formulation plants of A B C Company. 3.0 Responsibility 3.1 Officer / Executive warehouse shall be responsible for … Read more

sop for charge hand over between the shifts

  sop for charge hand over between the shifts 1, FROM CURRENT SHIFT TO NEXT SHIFT • Following are the instructions to be given by current shift officer to the next shift officer for charge • hand over. • Name of product/lot/workmen on each machine. • Status of each machine whether under changeover or under … Read more

amv report for paracetamol injection

  amv report for paracetamol injection Name of Product   PARACETAMOL INJECTION     Parameter         Analytical Method Validation for Paracetamol Injection  by HPLC Method followed     By HPLC     Supersede No.            Nil Total No of pages 19 Effective Date   TABLE OF CONTENTS Sr. No. Title Page — Product Description — Table of contents 1.0 Document … Read more

AMV Protocol for Sterility by Filtration Method

  AMV Protocol for Sterility by Filtration Method Analytical Method Verification  Protocol for Sterility by Filtration Method   Sr. No. Title Page No. — Table Of Contents 1.0 Protocol Approval 2.0 Qualification Team and Responsibilities 3.0 Introduction, Objective and Scope 3.1 Objective 3.2 Scope 4.0 Performance Qualification Pre-requisites 5.0 References 6.0 Performance Qualification Procedure 7.0 … Read more

sop for Performance Qualification Protocol for Bottle Washing Machine

  sop for Performance Qualification Protocol for Bottle Washing Machine   PERFORMANCE QUALIFICATION PROTOCOL 1.0 APPROVAL: 1.1  This protocol is prepared by QA   Department Quality Assurance Signature Name Designation Date   1.2 This protocol is reviewed by validation team Department Quality Assurance Production Engineering Signature Name Designation Date 2.0  TABLE OF CONTENT: SR. NO. … Read more

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