standard operating procedure for documentation and data control 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure on the preparation, revision, and distribution of necessary documents related to Manufacturing and Quality Control. 2.0. RESPONSIBILITY: 2.1 Head of the respective Department shall be: 2.1.1. Responsible for following the SOP. 2.2 … Read more
Interview Question on Quality Assurance 1) Tell me about your self sir i am ashok kumar son of manoj kumar my present address ram nagar near shiv mandir roorkee distt. Haridwar. I did B. pharma in 2015 . sir I had five year experience in pharma. I working in ABC pharma company. 2) what … 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 verification of calculator and excel sheet validation 1.0 OBJECTIVE 1.1 To lay down a procedure for Performance verification of Calculator and Excel sheet validation. 2.0 SCOPE 2.1 This procedure is applicable for Performance verification of Calculator and Excel sheet validation in Quality Control Department of 3.0 RESPONSIBILITY 3.1 QC Officer or … Read more
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