Procedure for defining job responsibility 1.0 OBJECTIVE 1.1 To lay down the procedure for Defining Job Responsibilities. 2.0 SCOPE 2.1 This procedure applies to all the responsible persons in the all Departments 3.0 RESPONSIBILITY 3.1 Head – Concerned Department. 4.0 ACCOUNTABILITY 4.1 Assistant Manager – Quality Assurance Department. 5.0 PROCEDURE 5.1 To … Read more
sop for performance qualification for analyst Table of Contents 1.0 PROTOCOL APPROVAL 2.0 OBJECTIVE 3.0 RESPONSIBILITY 4.0 ACCOUNTABILITY 5.0 METHOD 6.0 ABBREVIATIONS 7.0 ANNEXURES 1.0 PROTOCOL APPROVAL Designation Signature Date Prepared By (Sr. Executive QA) Checked By (Manager. Quality Control ) Approved By (Manager Quality Assurance) 2.0 OBJECTIVE 2.1 To evaluate the Knowledge, Skill, … Read more
Sop for Validation report for disinfectant efficacy EFFECTIVE DATE OF REPORT DATE OF QUALIFICATION SUPERSEDES REPORT No. REPORT CONTENTS Sr. No. TITLE PAGE No. REPORT PRE APPROVAL OBJECTIVE 1. SCOPE 2. RESPONSIBILITY 3. EQUIPMENTS DETAILS 4. REASON FOR QUALIFICATION 5. SITE OF STUDY 6. FREQUENCY QUALIFICATION 7. ANNEXURES 8. REFERENCES 9. DOCUMENTS TO … Read more
Sop for Method validation report for bacterial endotoxin test PRODUCT NAME BATCH NUMBER DATE OF TESTING DATE OF COMPLETION REPORT CONTENTS S. No. Title Page No. 1.0 Pre-Approval 2.0 Objective 3.0 Scope 4.0 Responsibility 5.0 Training … Read more
Sop for method validation microbiology sterility testing EFEECTIVE DATE SUPERSEDES NUMBER PRODUCT NAME BATCH NUMBER REPORT CONTENTS S. No. TITLE PAGE No. 1 REPORT PRE APPROVAL 2 OBJECTIVE 3 SCOPE 4 RESPONSIBILITY 5 TRAINING RECORDS 6 OBSERVATIONS OF CULTURE SUSPENSION 7 PREPARATION FOR FLUID … Read more
sop for validation report for preservative efficacy test PRODUCT NAME PRODUCT NAME BATCH NUMBER PRESERVATIVE NAME DATE OF TESTING DATE OF COMPLETION REPORT CONTENTS S. No. Title Page No. 1.0 Pre-Approval 2.0 Objective 3.0 Scope 4.0 Responsibility 5.0 Training record 6.0 Observation 7.0 Acceptance criteria 8.0 … Read more
Protocol cum report for efficacy qualification of uv light LOCATION: DRY POWDER INJECTION BLOCK AND MICROBIOLOGY LAB. Protocol No. Date of Qualification Supersedes Protocol Contains Pages PROTOCOL CONTENTS Point No. Section Title Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 Responsibility 5.0 Reason … Read more
sop for validation protocol for UV light efficacy of Dynamic Pass Box and Laminar Air Flow S. No. TITLE PAGE No. 1.0 PROTOCOL APPROVAL 2.0 OBJECTIVE 3.0 SCOPE 4.0 RESPONSIBILITY 5.0 METHODOLOGY 6.0 ACCEPTANCE CRITERIA 7.0 RECORDING 8.0 ABBREVIATIONS 9.0 REFERENCE … Read more
cleaning validation protocol capsule manufacturing equipment Scope of validation Capsule Manufacturing Equipment Document No. Supersede No. Effective Date 1.0 PROTOCOL APPROVAL: 1.1 This protocol is prepared by Department Quality Assurance Signature Name Designation Date 1.2 This protocol is reviewed by Department Quality Assurance Quality Control Production Engineering Signature Name Designation Date 1.3 This … Read more
cleaning validation protocol tablet manufacturing equipment Scope of validation Tablet Manufacturing Equipment Document No. Supersede No. Effective Date 1.0 PROTOCOL APPROVAL: 1.1 This protocol is prepared by Department Quality Assurance Signature Name Designation Date 1.2 This protocol is reviewed by Department Quality Assurance Quality Control Production Engineering Signature Name Designation … Read more