APEX PHARMA LIMITED

Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule Batch No.
BPR No. : BPR1/FP010-01 Std. Batch Size (Weight) : 100.740 Kg

Version No. : 01 Std. Batch Size (Nos.) : 184,158 Capsules

Superseded Doc. No. : Nil Std. Batch Size (Pack) : 9,208 Packs

Issue Date : MAY 2013 Batch Size of this Presentation : __________ Packs

Review Date : MAY 2016 Presentation : Alu-Alu Blister

Shelf Life : 24 Months Std. Pack Size : 5 X 4s

Product Description: Pink opaque body, deep blue opaque cap, containing off white color compacted powder.
Each capsule contains Cephradine Anhydrous BP (Compacted) Equivalent to 500 mg Cephradine.

Product Code : FP010 DAR No. : 170-43-60 Mfg. License No.: 132 & 363

MFG. DATE: EXP. DATE: No. of BPR (Part-1): _______ of ________ Issued by: Signature & Date

Approval of Current Version of the Document

Name Job Title Signature & Date

Prepared by Md. Al - Mamun Senior Production Executive

Checked by Md. Mehedi Hasan Executive, QA

Agreed by Shahazad M.A. Khasru General Manager

Approved by Md. Ruknuzzaman Rony Deputy Manager, PD & QA

1.0 Process Details:

Page 1 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

This BPR part-1 will cover Primary Packaging.

2.0 Dispensing (Primary Packaging materials)
2.1 Dispensing Procedure

2.1.1 Dispense the packaging materials according to the Dispensing Order. Record the Ref. No. from RELEASED LABEL. Ensure status label on each packet of material.
2.1.2 In case of loose packing materials, check that appropriate Product Status Label is fixed on the container.

2.1.3 Affix the dispensed label with all details on the Primary Packaging Materials.
2.1.4 Transfer the dispensed material by Trolley/ any suitable way from warehouse to Packaging area.

2.2 Receiving Procedure

2.2.1 Receive all Primary Packaging Materials from Material Transfer Area.

2.2.2 Production Executive/Supervisor/ and QA Executive/QA Inspector should check the correctness of the labels and quantity of the dispensed packing materials
against the Dispensing Order.

2.2.3 Transfer all Packaging Materials to specified Blister Room, if required store the packaging material in the Intermediate Staging Store.
2.3 Return Procedure
2.3.1 In case of return, production operator will weigh the quantity. Then Production Executive/QA Executive and warehouse Executive will check the return quantity.

Dispensing Order (Standard)

Item Code Name of Materials Unit Standard Quantity

1 PM00405 Printed Alu-Blister- Foil Aphrin- 500 Capsule - 219 mm Kg 25.000

2 PM00039 Alu-Alu Bottom Foil- 219 mm Kg 100.000

Label Claim: Each Aphrin 500 Capsule contains Cephradine Anhydrous Compacted Eq.to 500 mg Cephradine BP.

Dispensing Order (information) for this Batch/Presentation

Batch Size: _____________ Packs Pack Size: _______________ Equivalent Commercial Batch Size: ____________ Packs

Remarks: Local Commercial/ Physicians Sample/ Export Commercial/ Export Physicians Sample/ Institutional Order/ Others (please specify): __________________

Dispensing Order and Reconciliation of Packaging Materials for this Batch/ Presentation

Page 2 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

Checked by (Sign &

In- Quantit
*Projecte Quantit Quantity Received Date)
Sl. Item Name of Ref. QRN/ process y Dispense Received
Unit d y Issued consume by Prod.
No. Code Materials No. GRN rejection Returne d By WH by (WH) QA
Quantity (A) d (B) (Prod.) Pharmaci
(C) d (D) Executive
st

Printed Alu-
Blister- Foil
PM00
1 Aphrin- 500 Kg
405
Capsule - 219
mm

Total A B C D

[A - (B C D)]
Unaccountable Loss (%) = X100%= X100%= (Limit: 1.00%)
A

Alu-Alu
PM000
2 Bottom Foil- Kg
39
219 mm

Total A B C D

[A - (B C D)]
Unaccountable Loss (%) = X100%= X100%= (Limit: 1.00%)
A

*Projected Quantity Calculated By (Production Executive): sign & date Checked By (WHE): sign & date Checked By (QAE):
sign & date

Reconciliation Done By (TL): sign & date Checked By (PE/QAE): sign & date

Bin Card Posted By (Warehouse Personnel): sign & date

Remarks (if any):
Note: In case of shortage it shall be taken from the store through form number F/11/0003. In case of excess it shall be returned to the store.
3.0 Blistering

Page 3 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

Previous Product: Batch No.:

Area Cleanliness Checked by (QAE):

Precautions: 1. Remove all materials of the previous product before start of blistering.
2. Check cleanliness and dryness of all equipment and utensils before start processing.
3. Use facemask, hand gloves and protective dresses.
4. Check labels of the materials before using.
5. Ensure that line clearance checklist is signed by PE & QAE.
Equipment Used ID No. Previous Product Batch No. Cleanliness Checked by (QAE)

HOONG-A Blister Packing

02-010-002
Machine

S. S. Bowl N/A

LOG BOOKS COMPLETED AND AREA LABELED: SIGNATURE AND DATE (PE):

BLISTERING (IN CASE OF MACHINE RE-SETTING):

Previous Product: Batch No.:
Area Cleanliness Checked by (QAE):

Precautions: 1. Remove all materials of the previous product before start of blistering.
2. Check cleanliness and dryness of all equipment and utensils before start processing.
3. Use facemask, hand gloves and protective dresses.
4. Check labels of the materials before using.
10. 5. Ensure that line clearance checklist is signed by PE & QAE
Equipment Used ID No. Previous Product Batch No. Cleanliness Checked by (QAE)

HOONG-A Blister Packing

02-010-002
Machine

S. S. Bowl N/A

LOG BOOKS COMPLETED AND AREA LABELED: SIGNATURE AND DATE (PE):

3.1.1 Packing Identification Info

Page 4 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

Fill up the following table for updating BPR:

Production
Item Acceptance Criteria QA Executive
Executive
Manufacturing Signature & Date Signature & Date
MMM - YY
Date:
Expiry Date: MMM - YY

Embossing
Information

3.1.2 Working condition check specification

Sl. No. In Process Checks Specification Frequency

2
1 Pocket Forming Pressure NLT 6.0 kg/ cm i) At the beginning ii) Every two hours interval
0
2 Sealing Plate Temperature 170-180 C i) At the beginning ii) Every two hours interval
3 Line Speed 20-25 stroke / min i) At the beginning ii) Every two hours interval
4 Room Temperature 22 3C i) At the beginning ii) Every two hours interval
5 Relative Humidity (40-60)% i) At the beginning ii) Every two hours interval

IN-PROCESS (WORKING CONDITION CHECK) CONTROL SHEET

Pocket Forming Sealing Plate Room Relative

Recorded
Date Time Pressure Temperature Line Speed Temperature Humidity Remarks
By (PO)
(kg/ cm2) (C) (C) (%)

Page 5 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

Checked By (PP): ___________________

3.1.3 Pre-packing Check List

Put for ok; X for not ok and N/A for Not Applicable if it is needed during updating checklists.
Checked by
Item Acceptance Criteria
Production Executive QA Executive
Cleaning Certificate Cleaning Tag is valid & signed by QAE.
Line Clearance Certificate Line Clearance Certificate is valid & signed by QAE.
Identification All dispensed Items have proper Label.
Dispensed Items attributes. Aluminium Bottom foil & Printed Top Foil are given to meet the requirement. Check
status label against dispensing order.

Signature and Date Signature and Date

Remarks (if any):

3.1.4 Start-up check list for blister operation

Fill up the following table. Put for ok; X for not ok and N/A for Not Applicable if it is needed during updating checklists.

Page 6 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

Observation (by
Item Acceptance Criteria Observation (by PE) Observation (by QAE)
Operator)

Products Change parts Change parts for current product are available

1. Forming Plate (upper)

2. Forming Plate (lower)
3. Big Guide Rail

4. Small Guide Rail

5. Sealing plate (upper)

6. Sealing plate (lower)

7. Cooling plate (lower)

8. Draw of guide rail

Printed Top foil & Alu
bottom foil attachment
Blank Blister Preparation
9. Cutter
Printed Top Foil & bottom foil has been attached with the
machine properly.
Pocket forming is fine

Blister cutting is smooth

Sealing is found ok

Embossing is legible & clear.

Capsule is feeding by manually

Remarks (if any):

Signature & Date Signature and Date Signature and Date Signature and Date

3.1.5 Check list for blister operation :

Instructions:

Page 7 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

1. After operating the machine for about 5 minutes without Capsule, send blisters from consecutive four cuts for Leakage test to QA & record the result in the
table of section 3.1.7 Inform Production Executive and QA Executive for strip authentication. Do same during machine resetting.
2. Then put capsule and inform QA to carry out leak test.
3. When the initial leakage test meets the specification, carry on primary packing.
4. Each time blister machine is started and stopped, record the date and time with remarks for the machine shut down in the following table.
5. Fill up the following table for updating BPR:

Starting Date & Time Ending Date & Time Remarks Initial of the operator

Checked by (PE): ____________________

3.1.6 Primary Packaging Check Specifications:

Sl.
In process Checks
No.
1 Leak Test*
2 Text of Blister Foil
3 Batch Embossing Details
4 Blister Quality**
5 Cutting, Sealing
6 Foil Alignment
7 Pocket Formation
Frequency
At the beginning and every foil change
Every foil change by QA Executive / QAI.
At the beginning and every foil change
Hourly by QAI, Production operator and two hourly Production Executive and QA Executive.
At the beginning
Hourly by QAI, Production operator and two hourly Production Executive and QA Executive.
At the beginning
Hourly by QAI, Production operator and two hourly Production Executive and QA Executive.
At the beginning
Hourly by QAI, Production operator and two hourly Production Executive and QA Executive.
At the beginning
Hourly by QAI, Production operator and two hourly Production Executive and QA Executive.
At the beginning
Hourly by QAI, Production operator and two hourly Production Executive and QA Executive.

Note: * Check all strips of a single cutting for Leak Test. **Check for empty blisters, missing, tearing, heat affected strips, color change and appearance.
3.1.7 IN-Process (Primary Packaging Check) Control Sheet
Fill up the following table for updating BPR:

Page 8 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

Use () for OK, (X) for Not OK and (-) for Not Applicable

Batch No. Mfg. date: Exp Date:

Pocket Text of Batch Foil Checked By (Initial)

Blister Cutting,
Date Time Formatio Blister Embossin Alignmen Leak Test Remarks
Quality** Sealing
n Foil g Details t QAI/PO QAE/PE

Page 9 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

Batch No. Mfg. date: Exp Date:

Pocket Text of Batch Foil Checked By (Initial)

Blister Cutting,
Date Time Formatio Blister Embossin Alignmen Leak Test Remarks
Quality** Sealing
n Foil g Details t QAI/PO QAE/PE

Remarks:

3.1.8 Foil Rejection Record

Date Printed Top foil Alu-Bottom Foil Rejected by (PE) Checked by (QAE)

Page 10 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

Total (kg)

3.1.9 Job Allocation Data Sheet

Fill up the following table for updating BPR:

TIME (AM/PM)
Date Operation Operator ID No. Total Recorded By (Prod. Operator)
Start End

Capsule
Feeding

Blisterin Machine
g Operation

Strip
Checking

Total Man Hour

Checked By (Prod. Executive):

_______________
4.0 Note if any deviation, OOS (Valid/Invalid), change request regarding the BPR1:

5.0 Batch Closing Record

BPR Part 1 Closing Checklist:
Put for ok; X for not ok and N/A for Not Applicable if it is needed during updating checklists.
Observed by Observed by
Check List Documents are ok and attached with BPR
Production Executive QA Executive

Page 11 of 12
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR1/FP010-01 Version: 01

Checked By (Sign & Date): Approved By (Sign & Date):

Pre-packing Check 1. Cleaning Tag.

In-process Control 2. Line clearance certificate.

Blank strip signed by PP & QAE 3. With correct batch number and expiry.

Signature and Date Signature and Date

All the steps are done according to the BPR1 and if not, deviation / OOS / change request are reported (in step -4). All data are recorded properly.

Checked By (Production Executive): ______________ Checked By (QAE): ______________

6.0 Production Comments:

Production Approval: ________________

7.0 QA Comments:

QA Approval: ______________________

8.0 Revision History

Version
Date Doc. No. Reason for Revision
No.
MAY 2013 BPR1/FP010-1 01 First time issued for Batch packaging record of Aphrin 500 mg Capsule.

Page 12 of 12