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MFG. DATE: EXP. DATE: No. of BPR (Part-2): _______ of ________ Issued by: Signature & 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.
2.2.2 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.
2.3.1 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
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.
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
Shafipur, Gazipur, Bangladesh
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
Aphrin
Leaflet
Total A B C D E F
[A - (B C D E F)]
Unaccountable Loss (%) = X100%= X100%= ______________ % (Limit: 0.00%)
A
Page 3 of 16
APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh
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
PM00054
Apex
Hologram
Sticker
Total A B C D E F
[A - (B C D E F)]
Unaccountable Loss (%) = X100%= X100%= ______________ % (Limit: 1.00%)
A
Stability + Checked by
CodeItem
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
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)]
Unaccountable Loss (%) = X100%= X100%= ______________ % (Limit: 1.00%)
A
*Projected quantity Calculated By (PE): _________________ Checked by (WH Executive):__________________ Checked By (QAE): ______________________
Page 4 of 16
APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh
Batch No.
MRP Tk.
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
3.4 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
Page 6 of 16
APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh
In-Process (Off-Line Over Printing Check) Control Sheet for Inner Folded carton
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
Shafipur, Gazipur, Bangladesh
Start End
Overprinting
(IFC)
TIME (AM/PM)
Date Operation Operator ID No. Total Recorded By (TL/PE)
Start End
Insert folding
Page 8 of 16
APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh
Remarks :
Production Executive:
Signature
QA Executive
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.
Hourly by QAI and two hourly by Production Executive /QA Executive.
At the beginning
4. Text on Leaflet and Leaflet in IFC At least 5 pcs.
Hourly by QAI and two hourly by Production Executive /QA Executive.
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
Shafipur, Gazipur, Bangladesh
Page 10 of 16
APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh
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
Shafipur, Gazipur, Bangladesh
IFC Folding
Strip Checking
Page 12 of 16
APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh
IFC Closing
Hologram fixing
TIME (AM/PM)
Recorded By
Date Operation Operator ID No. Total
(TL)
Start End
Master Carton
Page 13 of 16
APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh
Grand Total Man Hour: _____________ Hours ; Done By (TL): ______________ ; Checked By (Production Executive): ______________________
(B + C D E F G) X 100
Yield (%) = _________________________________________= ______________ % (Limit: + 2.00%)
Theoretica
l batchsize
Page 14 of 16
APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh
5.0 Note if any deviation, OOS or change request regarding the BPR2
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.
Page 15 of 16
APEX PHARMA LIMITED
Shafipur, Gazipur, Bangladesh
8.0 QA Comments
QA Approval: ______________________
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