Recent Updates

DATE: 02/02/25

1. VALIDATION PLAN FOR COMPUTER SYSTEM
2. SYSTEM REQUIREMENT SPECIFICATION FOR COMPUTER SYSTEM
3. RISK ASSESSMENT FOR COMPUTER SYSTEM
4. INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM
5. OPERATIONAL QUALIFICATION FOR COMPUTER SYSTEM
6. TRACEABILITY MATRIX FOR COMPUTER SYSTEM
7. VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM
8. RISK ASSESSMENT ANNEXURE-1 (BEFORE QUALIFICATION)
9. RISK ASSESSMENT ANNEXURE-2 (AFTER QUALIFICATION)

DATE: 03/02/25

1. VALIDATION PLAN FOR COMPUTER SYSTEM
2. SYSTEM REQUIREMENT SPECIFICATION FOR COMPUTER SYSTEM
3. RISK ASSESSMENT FOR COMPUTER SYSTEM OF STABILTY PC
4. INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM OF STABILTY PC
5. OPERATIONAL QUALIFICATION FOR COMPUTER SYSTEM OF STABILTY PC
6. TRACEABILITY MATRIX FOR COMPUTER SYSTEM OF STABILTY PC
7. VALIDATION SUMMARY REPORT FOR COMPUTER SYSTEM OF STABILTY PC
8. RISK ASSESSMENT ANNEXURE-1 (BEFORE QUALIFICATION) OF STABILTY PC
9. RISK ASSESSMENT ANNEXURE-2 (AFTER QUALIFICATION) OF STABILTY PC

DATE: 05/02/215

1. Installation Qualification Protocol for Bin Washer

DATE: 06/02/25

1. Risk Assessment for Batch Processing
2. Contamination Control Strategy for Aseptic Preparations
3. Risk Assessment for Batch Processing
4. Risk Assessment for Production Process
5. Risk Assessment for Encapsulation Machine with Tumble Dryer
6. Risk Assessment for the movement of Dispensed Raw Materials
7. Risk Assessment related for Cross Contamination Control in Manufacturing Area

DATE: 07/02/25

1. Contamination Control Strategy for Sterile Products manufactured in Liquid Vial Line
2. Installation Qualification Bottle Sticker Labelling Machine
3. Operational Qualification Bottle Sticker Labelling Machine
4. INSTALLATION QUALIFICATION DOCUMENT OF PLC SYSTEM FOR AUTOMATIC ROTARY VACUUMATRIC DRY SYRUP FILLING WITH ROPP CAPPING MACHINE
5. OPERATIONAL QUALIFICATION DOCUMENT OF PLC SYSTEM FOR AUTOMATIC ROTARY VACUUMATRIC DRY SYRUP FILLING WITH ROPP CAPPING MACHINE
6. RISK ASSESSMENT AND IMPACT ANALYSIS OF PLC SYSTEM FOR AUTOMATIC ROTARY VACUUMATRIC DRY SYRUP FILLING WITH ROPP CAPPING MACHINE
7. INSTALLATION QUALIFICATION DOCUMENT OF PLC SYSTEM FOR DOUBLE SIDE ROTARY TABLET COMPRESSION MC 45 STN
8. OPERATIONAL QUALIFICATION DOCUMENT OF PLC SYSTEM FOR DOUBLE SIDE ROTARY TABLET COMPRESSION MC 45 STN
9. RISK ASSESSMENT AND IMPACT ANALYSIS OF PLC SYSTEM FOR DOUBLE SIDE ROTARY TABLET COMPRESSION MC 45 STN
10. RISK ASSESSMENT AND IMPACT ANALYSIS OF PLC SYSTEM FOR FLUID BED DRYER (FBD-250 KG)
11. Self Inspection Checklist for HR
12. Self Inspection Checklist for Production
13. Self Inspection Checklist for Quality Assurance
14. Self Inspection Checklist for Quality Control
15. Self Inspection Checklist for Warehouse

DATE: 13/02/25

1. Atenolol Tablets IP 50 mg (BPR)
2. Atorvastatin Calcium IP Tablets 10 mg (BMR)
3. Atorvastatin Calcium IP Tablets 10 mg (BPR)
4. Betahistine Tablets IP 8 mg (BMR)
5. Betahistine Tablets IP 8 mg (BPR)
6. Policy on Training
7. Policy on Analytical Method Transfer