sop for rework procedure 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for Rework of dosage forms which require change of packaging components(s). 2.0. RESPONSIBILITY: 2.1 Initiating Department shall be: 2.1.1 Responsible to fill up the requisition for rework in the form 2.1.2 Responsible seeking recommendations of Head – … Read more
sop for tolerance in the schedule of calibration 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for acceptable tolerance limit for the frequency of calibration of instruments. 2.0. RESPONSIBILITY: 2.1 Officer of Concerned Department shall be: 2.1.1 Responsible for calibration of the instrument in co-ordination with the Engineering … Read more
sop for change control procedure 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To describe the procedure to be followed for experimental change / permanent change. 2.0 RESPONSIBILITY: 2.1 The Originating department shall be: 2.1.1. Responsible for requesting for the Change Control form to Quality Assurance. 2.1.2. Responsible for fill up the … Read more
sop for control of process deviation 1.0. OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for handling of process deviations. 2.0. RESPONSIBILITY: 2.1 Head of the Concerned Department shall be: 2.1.1. Responsible for initiation as well as investigation on process deviation. 2.2 Quality Assurance shall be: 2.2.1 Responsible for … Read more
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