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
training evaluation questionnaire Training Date Topic of Training & Reference Procedure for Operation, Cleaning & Calibration of Shimadzu HPLC System with LC Solution Software Name of Trainee & Department Name of Trainer (s) Question Set No.: Department of Trainer (s) Quality Control Sr. No. Question(s) 1. What is the correct temperature verification … Read more
sop for stability management 1.0 OBJECTIVE: To describe the procedure for performing the stability studies of finished dosage forms in the package in which they are marketed under recommended storage condition during their shelf life and confirm the conformance with specification. The studies are conducted to establish or to support the recommended storage … Read more