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 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 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 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
sop for Operation and Cleaning of Purified Water Generation System 1.0 OBJECTIVE : 1.1 To lay down a procedure for operation and cleaning of Purified water Generation System. 2.0. SCOPE : 2.1 This procedure is applicable for operation and cleaning of Purified water Generation System situated 3.0. RESPONSIBILITY : 3.1 Operator Engineering Department … Read more
sop for Change control 1.0 OBJECTIVE : 1.1 To lay down a procedure for initiating, reviewing, approving/rejecting, implementing and closing the change in approved and/or validated states of quality system. 2.0. SCOPE : 2.1 This procedure is applicable to Initiation, Review and Evaluation, Approval/Rejection, Implementation and closure of change control procedure at … Read more
sop for approval of Contract Parties 1.0 OBJECTIVE : 1.1 To lay down a procedure for approval of contract parties. 2.0. SCOPE : 2.1 This procedure is applicable to approve contract parties providing services 2.1.1 Contract testing, 2.1.2 Annual maintenance service, 2.1.3 Calibration/validation service, 2.1.4 Laundry service, 2.1.5 Pest-control service, 2.1.6 Fire-extinguisher service, … Read more
sop for Validation master Plan 1.0 OBJECTIVE: To lay down Standard Operating Procedure for “Validation master Plan”. 2.0 SCOPE: This procedure is applicable for preparation, review, approval and authorization of Validation Master Plan 3.0 RESPONSIBILITY: QA (Officer/ Executive): shall be responsible Preparation, Distribution, Revision, Retrieval and Destruction of this SOP. Head QC: shall be … Read more
amv protocol for chloramphenicol 250 capsule ASSAY TESTBYUV SPECTROPHOTOMETRY analytical method validation protocol for chloramphenicol 250 capsule DOCUMENT NO. : PRODUCT NAME : CHLORAMPHENICOL 250 CAPSULE ISSUE DATE : SUPERSEDES : Nil TABLE OF CONTENT Analytical Method Protocol Approval Sheet S.No. Subject Page no. 1 Introduction 2 Objective 3 Scope 4 Responsibilities … Read more
training evaluation Sampling of Raw Materials questionnaire Training date Topic of training & reference Sampling of Raw Materials (SOP No.: Name of trainee & department Name of trainer (s) Question Set No.: Department of trainer (s) Quality Control Ques. No. Question 1.0 Who shall be responsible for sampling … Read more