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QUALITY CONTROL DEPARTMENT

Weekly Report
Report Period: From 28.10.2014 to 07.11.2014
Ref. No.: QC/Report/2014/01
1. Raw and Packaging Materials
1.1. Active Pharmaceutical Ingredients (API) & Excipients

Sl. Challan Challan Challan Received MRN MRN Received Tested Released Rejected
Material Name Remarks
No. Number Date Quantity Quantity Number Date Date Date Quantity Quantity
01 Esomeprazole Mg Pellets 8.5% 722 26.10.14 100.00 kg 100.00 kg 743 29.10.14 29.10.14 30.10.14 100.00 kg 0.00 Ok.
02 Esomeprazole Mg Pellets 8.5% SFC/069/ 28.10.14 100.00 kg 100.00 kg 744 29.10.14 29.10.14 30.10.14 100.00 kg 0.00 Ok.
2014
03 Dichlofenac Sodium Pellets Inst/0239 28.10.14 250.00 kg 250.00 kg 745 29.10.14 29.10.14 30.10.14 250.00 kg 0.00 Ok.
/4T/14

1.2. Packaging Materials (Primary & Secondary)

Sl. Challan Challan Challan Received MRN MRN Received Tested Released Rejected
Material Name Remarks
No. Number Date Quantity Quantity Number Date Date Date Quantity Quantity
Previous Pending Status:
1 Label of Novavit Gold 15 1062 24.09.14 31,600 pcs 31,600 pcs 3356 28.09.14 28.09.14 30.09.14 Sent to
Tablets HO to
short out.
2 Label of Novavit Gold 30 1062 24.09.14 22,600 pcs 22,600 pcs 3357 28.09.14 28.09.14 30.09.14 Sent to
Tablets HO to
short out.
3 PVDC milky white foil 214 827 30.09.14 518.250 kg 518.250 kg 3372 01.10.14 01.10.14 02.10.14 Need of
mm Machine

_________________ ___________________ ___________________


Asst. Manager, QC Head of Planning Managing Director
Page: 1 of 3
QUALITY CONTROL DEPARTMENT
Weekly Report
Report Period: From 28.10.2014 to 07.11.2014
Ref. No.: QC/Report/2014/01
Trial
4 Unprinted aluminium bottom 836 11.10.14 251.00 kg 251.00 kg 3380 12.10.14 12.10.14 14.10.14 Need of
foil 250mm Machine
Trial
5 Unprinted aluminium bottom 836 11.10.14 235.20 kg 235.20 kg 3381 12.10.14 12.10.14 15.10.14 Need of
foil 230mm Machine
Trial
6 Printed aluminium Hologram 0197 13.10.14 554820pcs 554820pcs 3384 14.10.14 14.10.14 16.10.14 Need of
Trial
7 Unprinted aluminium bottom 1188 17.10.14 433.80 kg 433.80 kg 3392 18.10.14 18.10.14 19.10.14 Need of
foil 214mm Machine
Trial
8 Unprinted aluminium bottom 1187 16.10.14 409.70 kg 409.70 kg 3395 19.10.14 19.10.14 20.10.14 Need of
foil 214mm Machine
Trial
9 PVDC milky white foil 214mm 794 01.10.14 480.55 kg 480.55 kg 3400 21.10.14 21.10.14 22.10.14 Need of
Machine
Trial
10 Printed aluminium top foil of 0926 20.10.14 118.47 kg 118.47 kg 3401 23.10.14 23.10.14 24.10.14 10.77 kg Complained
Ketoact Tablet 214mm to HOP
11 Alu security foil dia: 36mm Nil 22.10.14 20.00 kg 20.00 kg 3410 23.10.14 23.10.14 25.10.14 20.00 kg 0.00 Ok.
Running Status:
1 Printed Aluminium Top Foil of 2039 27.10.14 60.395Kg 60.395Kg 3419 28.10.14 28.10.14 29.10.14 60.395kg Nil Ok.
Pepzol 20 Capsule 250mm
2 Unprinted Aluminium Bottom 545 27.10.14 119.2Kg 119.2Kg 3420 28.10.14 28.10.14 30.10.14 Need of
Foil 235mm Machine
Trial
3 PVC Foil 117mm 545 27.10.14 50.00Kg 50.00Kg 3421 28.10.14 28.10.14 29.10.14 Need of
Machine
Trial
4 PVC Foil 93mm 545 27.10.14 110.6Kg 110.6Kg 3422 28.10.14 28.10.14 29.10.14 Need of
Machine
Trial

_________________ ___________________ ___________________


Asst. Manager, QC Head of Planning Managing Director
Page: 2 of 3
QUALITY CONTROL DEPARTMENT
Weekly Report
Report Period: From 28.10.2014 to 07.11.2014
Ref. No.: QC/Report/2014/01
5 Plastic Measuring Cup 13ml 37/14 26.10.14 14000Pcs 14000Pcs 3423 28.10.14 28.10.14 28.10.14 14000Pcs Nil Ok.
6 Amber Colour Pet Bottle PT0699 28.10.14 20160Pcs 20160Pcs 3424 29.10.14 29.10.14 29.10.14 20161Pcs Nil Ok.
28mmX135ml
7 Printed Aluminium Top Foil 197 28.10.14 113.170Kg 113.170Kg 3425 29.10.14 29.10.14 Under
Polyxim Capsule 229mm Test
8 Unprinted Aluminium Bottom 545 27.10.14 176.800Kg 176.800Kg 3426 29.10.14 30.10.14 30.10.14 Need of
Foil 230mm Machine
Trial
9 Unprinted Aluminium Bottom 545 27.10.14 127.700Kg 127.700Kg 3427 29.10.14 30.10.14 30.10.14 Need of
Foil 250mm Machine
Trial
10

2. In-Process Materials

Sl. Batch M.O. Blended Materials Com./Encap./Filling-Sealing Coating Remarks


Product Name
No. Number Number Test Date Status Test Date Status Test Date Status

3. Finished Products

FPTN Number of
Sl. Batch M.O. Batch Production FPTN Received Tested
Product Name Received Sample Status Remarks
No. Number Number Size Date Number Quantity Date
Date Taken

_________________ ___________________ ___________________


Asst. Manager, QC Head of Planning Managing Director
Page: 3 of 3
QUALITY CONTROL DEPARTMENT
Weekly Report
Report Period: From 28.10.2014 to 07.11.2014
Ref. No.: QC/Report/2014/01

4. Specimen Samples
4.1. Active Pharmaceutical Ingredients (API) & Excipients

Released/
Sl. Challan Challan Challan Received MRN Tested Released Rejected
Material Name MRN Date Rejected Remarks
No. Number Date Quantity Quantity Number Date Quantity Quantity
Date

4.2. Packaging Materials (Primary & Secondary)

Released/
Sl. Challan Challan Challan Received MRN Tested Released Rejected
Material Name MRN Date Rejected Remarks
No. Number Date Quantity Quantity Number Date Quantity Quantity
Date

5. PD Trail

Sl. Batch M.O. Blended Materials Com./Encap./Filling-Sealing Coating Remarks


Product Name
No. Number Number Tested Date Status Tested Date Status Tested Date Status

6. Retest of Raw Materials

RRR Released/
Sl. Batch R /P Expiry Retest Retest Sampled Tested 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 3
QUALITY CONTROL DEPARTMENT
Weekly Report
Report Period: From 28.10.2014 to 07.11.2014
Ref. No.: QC/Report/2014/01

7. Stability Study
7.1. Long Time/Real Time Stability Study

Sl. Batch Storage Status


Product Name Month Tested Date Remarks
No. Number Date

7.2. Accelerated Stability Study For PD Trail

Sl. Batch Storage Status


Product Name Month Tested 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 3

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