Aphrin 500 MG Capsule BPR 2

APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh
BATCH PACKAGING RECORD (BPR) - PART-2

Product Name : Aphrin 500 Capsule Batch No.
BPR No. : BPR2/FP132-01 Std. Batch Size (Weight) : 100.740 Kg
Version No. : 01 Batch Size (Nos.) : 184,158 Capsules
Superseded Doc. No. : Nil 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) Eq.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-2): _______ 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:

This BPR part-2 will cover Secondary Packaging.
Page 1 of 16
APEX PHARMA LIMITED

Product Name : Aphrin 500 Capsule
Batch No. :
BPR No. : BPR2/FP010-01 Version: 01
Checked By (Sign & Date): Approved By (Sign & Date):
2.0 Dispensing
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 Packaging Materials.
2.1.4 Carefully transfer the dispensed material by Trolley/ any suitable way from warehouse to Packing Hall.
2.2 Receiving procedure

2.2.1 Receive all Packaging Materials in the Material Transfer Area.
2.2.2 Production Executive and QA Executive 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 packing area, 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 Executive will check the return quantity.
Dispensing Order (Standard)
Standard
Sl. No. Item Code Name of Materials Unit
Quantity
1 PM00067 Aphrin 500 Capsule Carton Nos. 9,400 pcs
2 PM00058 Aphrin Leaflet Nos. 9,400 pcs
3 PM00054 Apex Hologram Sticker Nos. 9,400 pcs
4 PM00302 Master Carton for Aphrin 500 mg Capsule 100 ml (Big , 22X16X16) Nos. 41 pcs
Label Claim: Each Aphrin 500 Capsule contains Cephradine Anhydrous Compacted Eq.to 500 mg Cephradine BP.
Dispensing Order 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 Secondary Packaging Materials for this Batch/Presentation
Page 2 of 16
APEX PHARMA LIMITED

Batch No. :
Stability + Checked by
Item Code
In Excess
*Projecte Quantity retention + Quantity Quantity Dispense Receive (Sign & Date)
Name of Ref. QRN/ process overprintin Received
d Issued attached to consume Returned d By d By QA
Materials No. GRN Rejection g rejection By (WH) Prod.
Quantity (A) BPR d (E) (F) (WH) (PO) Executiv
(B) (C) Executive
sample(D) e
PM00067
Aphrin 500
Capsule
Carton
Total A B C D E F
[A - (B C D E F)]
Unaccountable Loss (%) = X100%= X100%= ______________ % (Limit: 0.00%)
A
Checked by
Code
Stability +
In Excess (Sign & Date)
*Projecte Quantity retention + Quantity Quantity Dispense Receive
Name of Ref. QRN/ process overprintin Received Name of Materials
d Issued attached to consume Returned d By d By
Materials No. GRN Rejection g rejection By (WH) QA
Quantity (A) BPR d (E) (F) (WH) (PO) Prod.
Item
(B) (C) Executiv

sample(D) Executive
e
PM00058
Aphrin
Leaflet
Total A B C D E F
[A - (B C D E F)]
A
Page 3 of 16
APEX PHARMA LIMITED

Batch No. :
Item Code
In Excess
(B) (C) Executive
sample(D) e
PM00054
Apex
Hologram
Sticker
Total A B C D E F
[A - (B C D E F)]
A
CodeItem
In Excess
(B) (C) Executive
sample(D) e
Master
PM00302
Carton for
Aphrin 500
mg Capsule
100 ml (Big,
22X16X16)
Total A B C D E F
[A - (B C D E F)]
A
*Projected quantity Calculated By (PE): _________________ Checked by (WH Executive):__________________ Checked By (QAE): ______________________
Bin Card Posted by (Warehouse Personnel): _____________________

Note: In case of shortage it shall be taken from the store through F/11/0003. In case of excess it shall be returned to the store. Investigate and explain if the reconciliation is out of stipulated
limit
Remarks (if any):
Reconciliation done by (Production Executive):_________________________ Checked by (QA Executive):______________________________
3.0 Packing Identification Info: Fill up the following table for updating BPR:
Page 4 of 16
APEX PHARMA LIMITED

Batch No. :
Item Acceptance Criteria Production Executive QA Executive
Batch No.
Manufacturing Date: MMM - YY

Signature & Date Signature & Date
Exp Date: MMM - YY
MRP Tk.
3.1 Pre-printing Check List:

Instructions:
1. After the initial start-up, if the printing area is being changed or if the printing type is being changed or if there is any changeover taken place in between the
operation; perform the checks again as mentioned in the following table.
2. Please follow & update the checklist provided below with appropriate record. Use () for OK, (X) for Not OK and (-) for Not Applicable if it is needed during updating
checklists.
3. Start the line only while the all correct materials are available in the area and area is labelled properly.
Printing star-up date and time(AM/PM)

Item Acceptance Criteria
Date & Time Date & Time Date & Time
Cleanliness Working area and printing materials are clean.
Line clearance certificate Line clearance certificate is valid and signed by QAE.
Required accessories (Printer, rubber stamp etc.) to perform printing are
Accessories
available
Production Executive
Signature
QA Executive
3.2 Line Start-Up Record

Start the line only while the all correct materials are available in the area and area is labelled properly.
Line Started By Production Executive: QA Executive:
3.3 Off-Line Overprinting Check Specification

Page 5 of 16
APEX PHARMA LIMITED

Batch No. :
Sl. No. of Sample Each

In- process Check Frequency
No. Time
Batch No., MFG. Date, EXP Date, MRP on At the beginning

1 At least 10 pcs.
IFC Hourly by QAI and two hourly by Production Executive/QAE.
At the beginning
2 Printing Quality At least 10 pcs.
Hourly by QAI and two hourly by Production Executive/QAE.
3.4 Fill up the following table for updating BPR for Inner Folded Carton printing operation.
Use () for OK, (X) for Not OK and (-) for Not Applicable.
In-Process (Off-Line Over Printing Check) Control Sheet for Inner Folded carton
Batch No. Mfg. date: Exp Date: MRP Tk:
Batch No., Mfg. Checked by

Time Printing ID No.
Date Date, Exp. date,
(AM/PM) Quality (Operator) Production QA
MRP on IFC LS / QAI Remarks
Executive Executive
Page 6 of 16
APEX PHARMA LIMITED

Batch No. :
In-Process (Off-Line Over Printing Check) Control Sheet for Inner Folded carton
Batch No., Mfg. Checked by

Time Printing ID No.
Date Date, Exp. date,
(AM/PM) Quality (Operator) Production QA
MRP on IFC LS / QAI Remarks
Executive Executive
Remarks:
3.5 Job Allocation Data Sheet (Continued)
Date Operation Operator ID No. TIME (AM/PM) Total Recorded By (TL/PE)
Page 7 of 16
APEX PHARMA LIMITED

Batch No. :
Start End
Overprinting
(IFC)
Total Man Hour
TIME (AM/PM)
Date Operation Operator ID No. Total Recorded By (TL/PE)
Start End
Insert folding
Total Man Hour
4.0 Packaging Operation

4.1 Pre-Packaging checklist
Instructions:
4.1.1 After the initial start-up, if the packaging area (conveyer belt) is being changed or if the packing type is being changed or if there is any changeover taken
place in between the operation; perform the checks again as mentioned in the following table.
4.1.2 Please follow & update the checklist provided below with appropriate record. Use () for OK, (X) for Not OK and (-) for Not Applicable if it is needed during
updating checklists.
4.1.3 Start the line only while the all correct materials are available in the area and area is labelled properly.
Page 8 of 16
APEX PHARMA LIMITED

Batch No. :
Packing Start-up Date & Time (am/pm)

Items Acceptance Criteria
Date & Time Date & Time Date & Time Date & Time
Line Clearance Line Clearance Certificate is valid & signed by

Certificate QAE
Current products name, Mfg date, Exp date & Belt- 01 Belt- 01 Belt- 01 Belt- 01
batch no. are being displayed at Conveyer Belt Belt- 02 Belt- 02 Belt- 02 Belt- 02
Display
:
Local Export Local Export Local Export Local Export
Packing Type (only
Secondary packing is being performed as: Country Country Country Country
one)
Physician Physician Physician Physician
Remarks :
Production Executive:
Signature
QA Executive
4.2 Secondary Packaging Operation Check Specification
No. of sample
Sl. No. In- process Check Frequency
(Each time)
Batch No., MFG. Date, EXP. Date, MRP, Text on IFC and batch. No., EXP. Date, At the beginning
1. At least 5 pcs.
Text on Strip Hourly by QAI and two hourly by Production Executive /QA Executive.
At the beginning
2. Print/ written quality on Master Carton Label At least 5 pcs.
Hourly by QAI and two hourly by Production Executive /QA Executive.
At the beginning
3. Number of Strips per IFC and Number of IFC per Shipping Carton At least 5 pcs.
At the beginning
4. Text on Leaflet and Leaflet in IFC At least 5 pcs.
At the beginning
5. Quantity (5) Strips/ IFC; (231) IFC/ Shipping Carton At least 5 pcs.
Hourly by QAI and two hourly by Production Executive / QA
Executive.
Page 9 of 16
APEX PHARMA LIMITED

Batch No. :
4.3 Fill up the following table for updating BPR:

Use () for OK, (X) for Not OK and (-) for Not Applicable.
In-Process (Secondary Packaging Check) Control Sheet
Batch No., Mfg. No. of Checked by (Initial)

Date, Exp. date, IFC /Master Print on
Time No. of
Date MRP, Text on IFC & Leaflet Hologram Carton Master
(AM/PM) Strips /IFC Production QA
Batch No., Exp. (231 IFC/ Carton Label LS/QAI
Executive Executive
Date, Text on strip MC)
Page 10 of 16
APEX PHARMA LIMITED

Batch No. :
In-Process (Secondary Packaging Check) Control Sheet
Batch No., Mfg. No. of

Print on Checked by (Initial)
Time Date, Exp. date, No. of IFC /Master
Date Leaflet Hologram Master
(AM/PM) MRP, Text on IFC & Strips /IFC Carton Production QA
Carton Label LS/QAI
Batch No., Exp. (231 IFC/ Executive Executive
Remarks:
No. of Sample Taken By QA: Retention: ____________________ Stability: _________________ Others: _______________ (For) __________________
Sign and Date
4.4 Operational information
Date Total no. of workers Time Conveyer belt No. of MC completed Supervised by Checked by
Page 11 of 16
APEX PHARMA LIMITED

Batch No. :
Start End identification no. (TL) (PE)
4.5 Job Allocation Data Sheet

Fill up the following tables for updating BPR:
TIME (AM/PM)
Recorded By
Date Operation Operator ID No. Total
(TL)
Start End
IFC Folding
Total Man Hour

TIME (AM/PM) Recorded By

Start End (TL)
Strip Checking
Total Man Hour

Start End (TL)
Page 12 of 16
APEX PHARMA LIMITED

Batch No. :
Strip & Leaflet Insertion
Total Man Hour

Start End (TL)
IFC Closing
Total Man Hour

Start End (TL)
Hologram fixing
Total Man Hour
TIME (AM/PM)
Recorded By
(TL)
Start End
Master Carton
Page 13 of 16
APEX PHARMA LIMITED

Batch No. :
Closing & Labeling
Total Man Hour
Grand Total Man Hour: _____________ Hours ; Done By (TL): ______________ ; Checked By (Production Executive): ______________________
4.10 Reconciliation of Finished Goods
Type of Yield Quantity (Nos.) Equivalent Commercial Packs
Theoretical yield at Manufacturing Stage (as packs) ______________________ = A
Actual yield as Local Commercial (as packs) ______________________ = B
Physicians Sample (as packs) ______________________ = C
Export Commercial (as packs) ______________________ = D
Export Physicians Sample (as packs) ______________________ = E
Retention Sample (as packs) ______________________ = F
Stability Sample (as strips) ______________________ = G
Sample Taken for Leak Test (as strips) ______________________ = H
In-process Reject (as Capsule) ______________________ = I
In-process Reject (as strips) ______________________ = J

[A - (B C D E F G H I J)] X 100
Unaccountable Loss (%) = ______________________________________________= ____________ % (Limit: + 2.00%)
A
(B + C D E F G) X 100
Yield (%) = _________________________________________= ______________ % (Limit: + 2.00%)
Theoretica
l batchsize
Recorded by (PO):_____________________ Checked by (PE):_____________________
Page 14 of 16
APEX PHARMA LIMITED

Batch No. :
Note: Investigate if the reconciliation is outside the stipulated limit.
5.0 Note if any deviation, OOS or change request regarding the BPR2
6.0 Batch Closing Record

1.1 BPR Part 2 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 Observed by QA
Check List Documents are ok and attached with BPR
Executive Executive
Pre-printing Check 1. Line clearance Certificate
Pre-packing Check 2. Line clearance Certificate
3. With correct batch number and expiry
Printed Packaging material IFC ------------ Pcs
specimen signed by PE & QAE. Product Leaflets ----------- Pcs
Shipper Label ----------- Pcs
Signature and Date Signature and Date
All the steps are done according to the BPR2 and if not, deviation / change request are reported (in step 5.0). All data are recorded properly.
Checked By (Production Executive): __________________ Checked By (QA Executive):__________________

7.0 Production Comments
Page 15 of 16
APEX PHARMA LIMITED

Batch No. :
Production Approval: ________________
8.0 QA Comments
QA Approval: ______________________
9.0 Revision History
Version
Date Doc. No. Reason for Revision
No.
MAY-2013 BPR2/FP010-1 01 First time issued in new format for Batch packaging record of Aphrin 500 mg Capsule
Page 16 of 16

Aphrin 500 MG Capsule BPR 2

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APEX PHARMA LIMITED

Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR) - PART-2

Approval of Current Version of the Document

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:

BATCH PACKAGING RECORD (BPR) - PART-2

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

2.2 Receiving procedure

2.3 Return Procedure

2 PM00058 Aphrin Leaflet Nos. 9,400 pcs

3 PM00054 Apex Hologram Sticker Nos. 9,400 pcs

Dispensing Order for this Batch/Presentation

BATCH PACKAGING RECORD (BPR) - PART-2

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

(B) (C) Executiv

BATCH PACKAGING RECORD (BPR) - PART-2

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

Bin Card Posted by (Warehouse Personnel): _____________________

BATCH PACKAGING RECORD (BPR) - PART-2

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

Item Acceptance Criteria Production Executive QA Executive

Manufacturing Date: MMM - YY

3.1 Pre-printing Check List:

Printing star-up date and time(AM/PM)

Cleanliness Working area and printing materials are clean.

3.2 Line Start-Up Record

Line Started By Production Executive: QA Executive:

3.3 Off-Line Overprinting Check Specification

BATCH PACKAGING RECORD (BPR) - PART-2

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

Sl. No. of Sample Each

Batch No., MFG. Date, EXP Date, MRP on At the beginning

Batch No. Mfg. date: Exp Date: MRP Tk:

Batch No., Mfg. Checked by

BATCH PACKAGING RECORD (BPR) - PART-2

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

Batch No. Mfg. date: Exp Date: MRP Tk:

Batch No., Mfg. Checked by

BATCH PACKAGING RECORD (BPR) - PART-2

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

Total Man Hour

3.6 Job Allocation Data Sheet (Continued)

Total Man Hour

4.0 Packaging Operation

BATCH PACKAGING RECORD (BPR) - PART-2

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

Packing Start-up Date & Time (am/pm)

Line Clearance Line Clearance Certificate is valid & signed by

4.2 Secondary Packaging Operation Check Specification

BATCH PACKAGING RECORD (BPR) - PART-2

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

4.3 Fill up the following table for updating BPR:

Batch No. Mfg. date: Exp Date: MRP Tk:

Batch No., Mfg. No. of Checked by (Initial)

BATCH PACKAGING RECORD (BPR) - PART-2

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

In-Process (Secondary Packaging Check) Control Sheet

Batch No. Mfg. date: Exp Date: MRP Tk:

Batch No., Mfg. No. of

Recorded by (PO):_ Checked by (PE):_

Checked By (Production Executive): Checked By (QA Executive):