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