sop for Analytical Method Transfer Analytical Method Transfer 1.0 PURPOSE To define a procedure for transfer of analytical methods from one laboratory to other laboratory. SCOPE This procedure is applicable to the transfer of analytical method (drug substances and medication items) for assay, related substances, dissolution, preservative/antioxidant content, uniformity content, residual solvents … Read more
PROTOCOL FOR HOLD TIME STUDY OF STERILE GARMENTS S. NO. TITLE PAGE NO. 1. PROTOCOL PRE APPROVAL 2. OBJECTIVE 3. SCOPE 4. RESPONSIBILITY 5. REASON FOR VALIDATION 6. TRAINING RECORD 7. OVERVIEW FOR HOLD TIME STUDY OF STERILE GARMENTS 8. PROCEDURE 9. ACCEPTANCE CRITERIA 10. FAILURE INVESTIGATION AND CORRECTIVE ACTION 11. DOCUMENTATION 12. REVALIDATION … Read more
sop for process validation 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure for process validation. 2.0. RESPONSIBILITY: 2.1 The Officer – Quality Assurance 2.1.1. Responsible to carry out the sampling as per sampling plan mentioned in validation protocol. 2.1.2. Responsible for sending intimation on sample withdrawal to … Read more
sop for swab sampling for validation of clean surfaces 1.0 OBJECTIVE To establish a procedure for swab sampling for validation of test surface to evaluate cleaning efficacy. 2.0 RESPONSIBILITY Quality Control Supervisor 3.0 ACCOUNTABILITY Quality Control Manager 4.0 PROCEDURE FOR CHEMICAL EVALUATION 4.1 SWAB : A clean room laundered polyurethane foam swab molded … Read more
cleaning validation maco and noel calculation formula INTRODUCTION OF CLEANING VALIDATION: The cleaning validation is to verify the effectiveness and consistency of the cleaning procedure for removal of product residues as well as the control of potential microbial contaminants in product. Selection of “Worst case” product is on the … 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