APEX PHARMA LIMITED

Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml Batch No.
BPR No. : BPR1/ FP013-01 Std. Batch Size (Weight) : 145.750 Kg
Version No. : 01 Std. Batch Size (Nos.) : 2,500 Phials
Superseded Doc. No. : Old Format of BPR Std. Batch Size (Pack) : 2,500 Phials
Batch Size of this
Issue Date : JUL 2013 : ______________ Packs
Presentation
130-ml Amber Glass Bottle with 28 mm
Review Date : JUL 2016 Presentation : Plastic Stopper & 28 mm Aluminium PP
Cap
Shelf Life : 24 months Std. Pack Size : 1s x 1

Product Description : White color free flowing granular powder with banana and orange flavour. After reconstitution each 5 ml contains Cephradine BP 125 mg.

Product Code : FP-013 DAR No. : 170-54-60 Mfg. License No.: 132 & 363 Page 1 of 13

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 Executive, Production

Checked by Md. Mehedi Hasan Executive, QA

Agreed by Shahazad M A Khasru General Manager, Factory

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

1.0 Process Details:

This BPR part 1 will cover Primary Packaging.

Page 1 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

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 from warehouse to Bottle washing room.
2.2 Receiving Procedure

2.2.1 Receive all Primary Packaging Materials in the 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 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 count the quantity. Then Production Executive, QA Executive and warehouse officer will check the return quantity.

Dispensing Order (Standard)

Item Code Name of Materials Unit Standard Quantity

1 PM00021 Amber Glass Bottle 130- ml Pcs 4080

2 PM00379 Plastic Stopper 28 mm Pcs 4080

3 PM00368 Aluminium PP Cap 28 mm Pcs 4100

Claim: After reconstitution each 5 ml contains Cephradine BP 125 mg.

Dispensing Order (information) for this Batch/Presentation

Batch Size: _____________ Packs Pack Size: 1s X 1 Equivalent Commercial Batch Size: ____________ Packs

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

Page 2 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Dispensing Order for this Batch/Presentation

Page 3 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Checked by (Sign & Date)

Sl. Item *Projected Quantity Quantity Done By WH
Name of Materials Unit Ref. No. QRN/GRN
No. Code Quantity Issued Returned (Sign & Date) Prod. QA
Executive Executive

PM000 Amber Glass Bottle

1 Pcs
21 130-ml

PM003
2 Plastic Stopper 28 mm Pcs
79

PM003 Aluminium PP Cap 28

3 Pcs
68 mm

*Projected quantity calculated by (Production Executive): sign & date Checked by (WHE): sign & date Checked by (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.
2.4 Washing of the bottles

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 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Equipment Used ID No. Previous Product Batch No. Cleanliness Checked by (QAE)

Bottle Washing Machine 02-096-001

Log books completed and area labeled: Signature and Date (PE):

a) Check that the required quantities of bottles are available.

Size of the bottle: 75 ml

Quantity of bottles requisitioned: ________________ nos.

b) Bottle Washing Procedure:

Wash the bottles according to SOP/08/127.

Time started: _________________ Time finished: __________________

Done By (PO): ___________________ Checked By (PE): __________________ Checked By (QAE): ___________________

2.5 Drying & Dryness checking of the bottle

A) Drying of the bottle

Dry the bottles in Tray dryer and maintain the temperature (120-140) 0C according to SOP/08/088.

Equipment Used ID No. Previous Product Batch No. Cleanliness Checked by (QAE)

Tray Dryer 02-025-001

Log books completed and area labeled: Signature and Date (PE):
Time Started: _____________ Time Finished: ________________

Done By (PO): ___________________ Checked By (PE): __________________ Checked By (QAE): __________________

B) Checking Drying Temperature

Page 5 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Date Time (am/pm) Temperature Done by (PO) Checked by (PE/QAE) Remarks

1.

2. Set Temp.
(120-
3. 140)0C

4.

5.

C) Checking Dryness of the bottles

a) Collect bottle from each lot and checked dryness of the bottle by poured dry crushed sucrose into the bottle then shake the bottle smoothly. Check sucrose
adherence with bottle.
b) If sucrose is adhere with glass bottle then investigate cause of low dryness and send the bottle for further drying.
c) If sucrose is not adhering with glass bottle then give pass the bottle for filling.

Lot Bottle dryness Done by (QAI) Checked by (QAE) Remarks

Lot # 01

Lot #02

Lot #03

2.6 Filling and Cap sealing

Precautions:
1. Remove all materials of the previous product before start of manufacturing.
2. Check cleanliness and dryness of all equipment and utensils before start processing.
3. Use facemask, hand gloves and protective dresses. Avoid dust and inhalation of powder.
4. Check labels of the materials before using.
5. Ensure that the line clearance checklist and CLEANED TAG are signed by PE and QAE.

Page 6 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Equipment Used ID No. Previous Product Batch No. Cleanliness Checked by (QAE)

Augar Filling Machine 02 145 - 001

Cap Sealing Machine 02 146 - 001

Log books completed and area labeled: Signature and Date (PE):

a) Adjust the fill weight .The adjustment of the accurate fill weight will be ensured by successively weighing filled bottles from the dosing point. If the fill weight meets the specification,
then allow to operate for the regular operation.

Done By (PO): ___________________ Checked By (PE): __________________ Checked By (QAE): __________________

b) The in-process checking will be conducted by the QA at 60 minutes interval. (See Doc. IPC/M/ FP013-01)
nspection
Initial Parameter Checking Record: Fill weight: ______58.30_____g/Bottle

Sl. Done by
Parameter Standards Result Checked By (PE)
No. (PO)

1 Appearance White color free flowing granular powder with mango flavor

(____56.84_______ to ___61.22_______) g
2 Individual fill weight (g)
[-2.5% to +5% of the theoretical Fill Weight]

(____58.30_____ to ___60.05___) g
3 Average fill wt. of 3 bottles (g)
[0 to +3% of the theoretical Fill Weight]

Initial Parameter Checking Record (In Case of Machine Resetting):

Sl. Done by
Parameter Standards Result Checked By (PE)
No. (PO)

1 Appearance of powder White color free flowing granular powder with mango flavor

(___58.64________ to ____61.22______) g
2 Individual fill weight (g)
[-2.5% to +5% of the theoretical Fill Weight]

(____58.30_____ to ___60.05___) g
3 Average fill wt. of 3 bottles (g)
[0 to +3% of the theoretical Fill Weight]
2.7 Parameters Checking
Page 7 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Sl. No. In process Checks Frequency

At the beginning
1 Appearance
Half Hourly by PO and Hourly Production Executive, QA Executive / Inspector/LS.
At the beginning
2 Sealing
Half Hourly by PO and Hourly Production Executive, QA Executive / Inspector/LS.
At the beginning
3 Visible Foreign Particle
Half Hourly by PO and Hourly Production Executive, QA Executive / Inspector/LS.
At the beginning
4 Filled Weight
Half Hourly by PO and Hourly Production Executive, QA Executive / Inspector/LS.

2.8 In-Process Control Sheet

Fill up the following table for updating BPR 1:
Use () for OK, (X) for Not OK and (-) for Not Applicable and write down wt. in numerical value

Batch No. Mfg. date: Exp Date:

Checked By (Initial)
Appearance
Visible Foreign Individual Filled Average Filled
Date Time (Powder, Bottle, Sealing Remarks
Particle Weight Weight
Cap) PO/LS/QAI PE / QAE

Bottle#1
Bottle #2
Bottle #3
Bottle#1
Bottle #2

Bottle #3

Bottle#1
Bottle #2
Bottle #3
Bottle#1

Page 8 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Batch No. Mfg. date: Exp Date:

Checked By (Initial)
Appearance
Visible Foreign Individual Filled Average Filled
Date Time (Powder, Bottle, Sealing Remarks
Particle Weight Weight
Cap) PO/LS/QAI PE / QAE

Bottle #2
Bottle #3
Bottle#1
Bottle #2
Bottle #3
Bottle#1
Bottle #2
Bottle #3
Bottle#1
Bottle #2
Bottle #3
Bottle#1

Bottle #2

Bottle #3

Bottle#1

Bottle #2

Bottle #3
Bottle#1

Bottle #2

Bottle #3

Bottle#1
Bottle #2

Page 9 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Batch No. Mfg. date: Exp Date:

Checked By (Initial)
Appearance
Visible Foreign Individual Filled Average Filled
Date Time (Powder, Bottle, Sealing Remarks
Particle Weight Weight
Cap) PO/LS/QAI PE / QAE

Bottle #3
Bottle#1

Bottle #2

Bottle #3
Bottle#1
Bottle #2
Bottle #3
Bottle#1
Bottle #2
Bottle #3
Bottle#1
Bottle #2
Bottle #3
Bottle#1
Bottle #2
Bottle #3
Bottle#1
Bottle #2
Bottle #3
Remarks:
Checked by (PE): _____________________

2.9 Rejection Record

Aluminium PP Cap 28
Date Amber Glass Bottle 75 ml Plastic Stopper 28 mm Rejected by (PE) Checked by (QAE)
mm

Page 10 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Total (Pcs)

2.10 Reconciliation of Primary Packaging Materials

Sl Aluminium PP Cap
Amber Glass Bottle Plastic Stopper Done By
No Details Unit Checked By (QAE)
75 - ml 28 mm 28 mm (PE)
.

1.
Quantity issued for the batch (A) Pcs
2. Quantity consumed for Bottle Filling &
Pcs
Sealing (B)
3. In-process rejection (C) (From Step
Pcs
2.9)
4.
Quantity returned to store (D) Pcs
[A - (B C D)]
5. Process Loss (%) = X100%
A
Limit: 1.00%

Explain if reconciliation is out of limit:

2.11 Job Allocation Data Sheet

Fill up the following table for updating BPR:
TIME (AM/PM) Recorded By (Prod.
Date Operation Operator ID No. Total
Start End Operator)

Page 11 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Bottle Washing

Bottle Drying

Powder Filling

Cap Sealing

Total Man Hour

Checked By (PE): _______________

2.12 Note if any deviation, OOS (Valid/Invalid), change request regarding the BPR Part-1:

2.13 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 Production
Check List Documents are ok and attached with BPR Observed by QA Executive
Executive
Pre-packing Check 1. Cleaning Tag (s).
In-process Control 2. Line clearance certificate.

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 2.12). All data are recorded properly.

Checked By (PE) ______________ Checked By (QAE): ______________

Page 12 of 13
 APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) PART-1

Product Name : Aphrin PFS, 100 ml
Batch No. :
BPR No. : BPR1/FP013-01 Version: 01

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

Production Comments

Production Approval: ________________

QA Comments

QA Approval: ______________________
2.14 Revision History

Version
Date Doc. No. Reason for Revision
No.
BPR1/FP013-
JUL 2013 01 First time issued in new format for Batch Packaging Record (Part-1) of Aphrin PFS, 100 ml.
01

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