QUALITY CONTROL DEPARTMENT
Weekly Report
Report Period: From 21.10.2014 to 26.10.2014
Ref. No.: QC/Report/2014/01
1. Raw and Packaging Materials
1.1. Active Pharmaceutical Ingredients (API) & Excipients
Released/
Sl. Challan Challan Challan Received MRN Test Released Rejected
Material Name MRN Date Rejected Remarks
No. Number Date Quantity Quantity Number Date Quantity Quantity
Date
01 Tamsulation HCl 0.2 % Pellets 25.00 kg 25.00 Kg 738 No Document
02 Calcium Carbonate 1192 21.10.14 25.00 Kg 25.00 Kg 739 23.10.14 24.10.14 24.10.14 0.00 Kg 25.00 Kg
03 EHGC Shell for Pepzol 20 Cap 201410175 19.10.14 10,50,000 10,50,000 740 23.10.14 23.10.14 24.10.14 10,50,000 0.00
04 Esomeprazole Mg Pellets 8.5% 721 22.10.14 100.00 Kg 100.00 Kg 741 23.10.14 26.10.14 26.10.14 25.00 Kg 75.00 Kg
05 EHGC Shell for Perizol 40 Cap 201410026 09.10.14 5,00,000 5,00,000 742 23.10.14 23.10.14 24.10.14 5,00,000 0.00
06 DM Water --- --- --- --- 25.10.14 25.10.14 1,000 Lt. 0.00
1.2. Packaging Materials (Primary & Secondary)
Released/
Sl. Challan Challan Challan Received MRN Released Rejected
Material Name MRN Date Test Date Rejected Remarks
No. Number Date Quantity Quantity Number Quantity Quantity
Date
2. In-Process Materials
2.1. Blended Materials
Sl. Batch M.O. Blended Sampled Number of Sample Number of Sample
Product Name Test Date Status Remarks
No. Number Number Date Date Taken for Test Test Done
_________________ ___________________ ___________________
Asst. Manager, QC Head of Planning Managing Director
Page: 1 of 5
QUALITY CONTROL DEPARTMENT
Weekly Report
Report Period: From 21.10.2014 to 26.10.2014
Ref. No.: QC/Report/2014/01
2.2. After Compression/Encapsulation/Filling-Sealing
Sl. Batch M.O. Comp/Encap/ Sampled Number of Sample Number of Sample
Product Name Test Date Status Remarks
No. Number Number Filling Date Date Taken for Test Test Done
2.3. After Coating
Sl. Batch M.O. Coating Sampled Number of Sample Number of Sample
Product Name Test Date Status Remarks
No. Number Number Date Date Taken for Test Test Done
3. Finished Products
FPTN Number of Test Status
Sl. Batch M.O. Batch Production Received
Product Name Pack Size Received Sample Date Remarks
No. Number Number Size Date Quantity
Date Taken
_________________ ___________________ ___________________
Asst. Manager, QC Head of Planning Managing Director
Page: 2 of 5
QUALITY CONTROL DEPARTMENT
Weekly Report
Report Period: From 21.10.2014 to 26.10.2014
Ref. No.: QC/Report/2014/01
4. Specimen Samples
4.1. Active Pharmaceutical Ingredients (API) & Excipients
Released/
Sl. Challan Challan Challan Received MRN Released Rejected
Material Name MRN Date Test Date Rejected Remarks
No. Number Date Quantity Quantity Number Quantity Quantity
Date
4.2. Packaging Materials (Primary & Secondary)
Released/
Sl. Challan Challan Challan Received MRN Released Rejected
Material Name MRN Date Test Date Rejected Remarks
No. Number Date Quantity Quantity Number Quantity Quantity
Date
5. PD Trail
5.1. Blended Materials
Sl. Batch M.O. Blended Sampled Number of Sample Number of Sample
Product Name Test Date Status Remarks
No. Number Number Date Date Taken for Test Test Done
_________________ ___________________ ___________________
Asst. Manager, QC Head of Planning Managing Director
Page: 3 of 5
QUALITY CONTROL DEPARTMENT
Weekly Report
Report Period: From 21.10.2014 to 26.10.2014
Ref. No.: QC/Report/2014/01
5.2. After Compression/Encapsulation/Filling-Sealing
Sl. Batch M.O. Comp/Encap/ Sampled Number of Sample Number of Sample
Product Name Test Date Status Remarks
No. Number Number Filling Date Date Taken for Test Test Done
5.3. After Coating
Sl. Batch M.O. Coating Sampled Number of Sample Number of Sample
Product Name Test Date Status Remarks
No. Number Number Date Date Taken for Test Test Done
6. Retest of Raw Materials
RRR Released/
Sl. Batch R /P Expiry Retest Retest Sampled Test Released Rejected
Material Name Received Rejected Remarks
No. Number Number Date Date Quantity Date Date Quantity Quantity
Date Date
_________________ ___________________ ___________________
Asst. Manager, QC Head of Planning Managing Director
Page: 4 of 5
QUALITY CONTROL DEPARTMENT
Weekly Report
Report Period: From 21.10.2014 to 26.10.2014
Ref. No.: QC/Report/2014/01
7. Stability Study
7.1. Long Time/Real Time Stability Study
Sl. Batch Storage Status
Product Name Month Test Date Remarks
No. Number Date
7.2. Accelerated Stability Study For PD Trail
Sl. Batch Storage Status
Product Name Month Test Date Remarks
No. Number Date
8. Documentation
Sl. Document Review Prepared
Title Version Effective Date Purpose Remarks
No. Number Date Date
Copy To:
i. Planning Department
ii. QC Report File
_________________ ___________________ ___________________
Asst. Manager, QC Head of Planning Managing Director
Page: 5 of 5
