BPR - FP025-1 V-1Azinil 35ml PFS

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

Product Name : AZINIL PFS 35 ML Batch No.
BPR No. : BPR/FP026-01 Std. Batch Size (Weight) : 50.0 Kg
Version No. : 01 Std. Batch Size (Nos.) : 2678 bottles
Superseded Doc. No. : Nil Std. Batch Size (Pack) : 2678 Packs
Batch Size of this
Issue Date : SEP 2012 : __________ Packs
Presentation
75 ml amber glass bottle with
Review Date : SEP 2015 Presentation :
aluminium cap
Shelf Life : 24 Months Std. Pack Size :1X1
Product Description: : Each 5ml contains Azithromycin USP 200 mg white to off white free flowing granular powder in 75 ml Amber glass bottle with aluminium cap.
Product Code : FP026 DAR No. : 170- 108 -60 Mfg. License No.: 132 & 363 Page 1 of 17
MFG. DATE: EXP. DATE: Issued by: Signature & Date
Approval of Current Version of the Document

Name Job Title Signature & Date
Prepared by Md. Abdus Salam Production Executive
Checked by Md. Khosruzzaman Sr. Executive -QAD
Agreed by Md. Saiful Islam Production Manager
Approved by Md. Ruknuzzaman Rony Deputy Manager, PD & QA
1.0 Process Details:

This part will cover Secondary Packaging.
2.0 DISPENSING (Secondary 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 Packaging area.
Page 1 of 17
APEX PHARMA LIMITED

Product Name : AZINIL PFS 35 ML
Batch No. :
BPR No. : BPR/FP026-01 Version: 01
Checked By (Sign & Date): Approved By (Sign & Date):
2.2 Receiving Procedure:

2.2.1 Receive all 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 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/Officer, QA Executive and warehouse executive will check the return
quantity.
Dispensing Order (Standard)
Sl. No. Item Code Name of Materials Unit Standard Quantity
01 PM00101 Azinil PFS-35 ml Carton Nos. 2800 pcs
02 PM00106 Azinil PFS-35 ml Label Nos. 2800 pcs
03 PM00104 Azinil Leaflet for PFS Nos. 2750 pcs
04 PM00377 Plastic Spoon 5 ml Nos. 2850 pcs
05 PM00376 Plastic Dropper 5 ml Nos. 2850 pcs
06 PM00167 Dozon Box Azinil PFS 35 ml Nos. 225 pcs
07 PM00054 Apex Hologram Sticker Nos. 2850 pcs
Claim: Each 5ml contains Azithromycin USP 200 mg white to off white free flowing granular powder.
Dispensing Order for this Batch/Presentation
Batch Size: _____________ Packs Pack Size: 1 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 17
APEX PHARMA LIMITED

Batch No. :
Dispensing Order and Reconciliation of Secondary Packaging Materials for this Batch/Presentation
Stability + Checked by
Quantit Dispensed
*Projecte Quantit In process Quantity Retention Receive (Sign & Date)
Code
Name of M.R.R.No y By
d QC Ref No. y Issued Rejection consume + attached d By
Material ./ G.R.N Returne (Warehouse
Quantity (A) (B) d (C) to BPR (WH) PE QAE
d (D) )
sample(D)
PM00101
Azinil
PFS-35
ml Carton
Total A B C D E
[A - (B C D E )]
Unaccountable Loss (%) = =
X100% X100% = (Limit: 1.00%)
A
Quantit
Quantity Retention Dispensed Received (Sign & Date)
*Projecte Quantity In process y
Code
Name of M.R.R.No consume + By By (WH)

d QC Ref No. Issued Rejection Returne
Material ./ G.R.N d attached (Warehouse
Quantity (A) (B) d PE QAE
(C) to BPR )
(D)
sample(D)
PM00106
Azinil
PFS-35
ml Label
Total A B C D E
[A - (B C D E )]
X100% X100% = (Limit: 1.00%)
A
Page 3 of 17
APEX PHARMA LIMITED

Batch No. :
Stability + Quantit Checked by

Quantity Dispensed
*Projecte Quantity In process Retention y Received (Sign & Date)
Code
Name of M.R.R.No consume By

d QC Ref No. Issued Rejection + Returne By (WH)
Material ./ G.R.N d (Warehouse
Quantity (A) (B) attached d PE QAE
(C) )
to BPR (D)
sample(D)
6PM0010
Azinil
PFS-35
ml Label
Quantit
Quantity Retention Dispensed (Sign & Date)
*Projecte Quantity In process y
Code
Name of M.R.R.No consume + By

d QC Ref No. Issued Rejection Returne Received
Material ./ G.R.N d attached (Warehouse
Quantity (A) (B) d By (WH) PE QAE
(C) to BPR )
(D)
sample(D)
PM00104
Azinil
Leaflet
for PFS
Total A B C D E
[A - (B C D E )]
X100% X100% = (Limit: 1.00%)
A
Page 4 of 17
APEX PHARMA LIMITED

Batch No. :
Checked by
Dispensed (Sign & Date)
Quantity In process Quantity Quantity
Code
Name of *Projected M.R.R.No QC Ref Stability By

Issued Rejection consumed Returned Received
Material Quantity ./ G.R.N No. + (Warehouse
(A) (B) (C) (D) By (WH) PE QAE
Retentio )
n
PM00377
Plastic
Spoon 5
ml
Total A B C D E
[A - (B C D E )]
Unaccountable Loss (%) = X100% = X100% = (Limit: 1.00%)
A
Checked by
Code
Name of *Projected M.R.R.No QC Ref Stability By Received

Issued Rejection consumed Returned
Material Quantity ./ G.R.N No. + (Warehouse By (WH)
(A) (B) (C) (D) PE QAE
Retentio )
n
PM00376
Plastic
Dropper
5 ml
Total A B C D E
[A - (B C D E )]
Unaccountable Loss (%) = X100% = X100% = (Limit: 1.00%)
A
Page 5 of 17
APEX PHARMA LIMITED

Batch No. :
Checked by
Code
Name of *Projected M.R.R.No QC Ref Stability By

Issued Rejection consumed Returned Received
Material Quantity ./ G.R.N No. + (Warehouse
(A) (B) (C) (D) By (WH) PE QAE
Retentio )
n
PM00377
Plastic
Spoon 5
ml
Checked by
Dispensed
*Projecte Quantity In process Quantity Quantity (Sign & Date)
Code
Name of M.R.R.No./ By Received

d QC Ref No. Issued Rejection consumed Returned
Material G.R.N (Warehouse By (WH)
Quantity (A) (B) (C) (D) PE QAE
)
PM00167
Dozon Box
Azinil PFS
35ml
D
Total A B C
[A - (B C D )]
X100% X100% = (Limit: 1.00%)
A
Page 6 of 17
APEX PHARMA LIMITED

Batch No. :
Checked by
(Sign & Date)
Dispensed
*Projecte M.R.R.N Quantity In process Quantity Stability + Quantity Received
Code
Name of QC Ref By
d o./ Issued Rejection consumed Retention+ Returned By (WH)
Material No. (Warehouse
Quantity G.R.N (A) (B) (C) attached (D) PE QAE
)
to BPR
sample(D)
PM00054
Apex
Hologram
Sticker
Total A B C D E
[A - (B C D E )]
X100% X100% = (Limit: 1.00%)
A
*Projected quantity calculated by (Production Executive): sign & date Checked by (WHO): sign & date Checked by (QAE):
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.
Explain if reconciliation is out of limit:
Reconciliation done by Bin card posted by Sign & date
Checked by (PE) : ( Warehouse Personnel ):
(PS) : Sign & date Sign & date
3.0 Packing Identification Info: Fill up the following table for updating BPR:
Item Acceptance Criteria Production Executive QA Executive
Batch No. Signature & Date Signature & Date
Page 7 of 17
APEX PHARMA LIMITED

Batch No. :
Manufacturing Date: MMM- YY
Expiry 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.
Accessories Required accessories (Printer, rubber stamp etc.) to perform printing are available
Production Executive
Signature
QA Executive
3.1.1 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: Signature & Date Production Executive: Signature & Date QA Executive: Signature & Date
Page 8 of 17
APEX PHARMA LIMITED

Batch No. :
Remarks:
3.1.2 Off-Line Overprinting Check Specification:
Sl. No. In- process Check No. of Sample Each Time Frequency
At the beginning
1 Batch No., MFG. Date, EXP Date on Label At least 10 pcs.
Hourly by QAI/ LS and two hourly by Production Executive/QAE.
Batch No., MFG. Date, EXP Date, MRP on At the beginning

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

Time Batch No., Mfg. Printing ID No.
Date Date, Exp date & PS/QAI Production QA
(AM/PM) Date, Exp date on Quality (Operator)
MRP on IFC Executive Executive
Label
Page 9 of 17
APEX PHARMA LIMITED

Batch No. :
In-Process (Off-Line Over Printing Check) Control Sheet for Label / IFC
Batch No. Mfg. date: Exp Date: MRP Tk:
Batch No., Mfg. Checked by

Time Batch No., Mfg. Printing ID No.
Date Date, Exp date & PS/QAI Production QA
(AM/PM) Date, Exp date on Quality (Operator)
MRP on IFC Executive Executive
Label
Remarks:
4.0 Secondary Packaging Operation:
4.1 Operation Labeling & Packing:
Page 10 of 17
APEX PHARMA LIMITED

Batch No. :
4.1.1 Pre-Packaging checklist:
Instructions:
1. After the initial start-up, if the packaging area (conveyer belt/Table) 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.
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.
Items Acceptance Criteria Packing Start-up Date & Time (am/pm)

Date & Time Date & Time Date & Time Date & Time
Line Clearance Line Clearance Certificate is valid & signed by

Certificate QAE.
Display Current products name, Mfg date, Exp date &
batch no. are being displayed at Conveyer
Belt No.- Belt No.- Belt No.- Belt No.-
Belt :
Packing Type Secondary packing is being performed as: Local Export Local Export Local Export Local Export
(only one) Physician Country Physician Physician Physician Country
Country Country
Remarks:
Production Executive:
Signature Sign & Date Sign & Date Sign & Date Sign & Date
QA Executive:
Sign & Date Sign & Date Sign & Date Sign & Date
4.1.2 Secondary Packaging Operation Check Specification:
Page 11 of 17
APEX PHARMA LIMITED

Batch No. :
No. of sample
Sl. No. In- process Check Frequency
(Each time)
At the beginning
1. Batch No., MFG. Date, EXP. Date, MRP, Text on IFC At least 5 pcs. Hourly by QAI/ PS and two hourly by Production Executive/QAE.
At the beginning
2. Batch No., MFG. Date, EXP. Date on Label At least 5 pcs Hourly by QAI/ PS and two hourly by Production Executive/QAE.
At the beginning
3. Label Alignment &l fixing on Bottle At least 5 pcs Hourly by QAI/ PS and two hourly by Production Executive/QAE.
At the beginning
4. Batch No., MFG. Date, EXP. Date on Master Carton At least 5 pcs.
Hourly by QAI/ PS and two hourly by Production Executive/QAE.
At the beginning
5. Text on Leaflet and Leaflet in IFC At least 5 pcs. Hourly by QAI/ PS and two hourly by Production Executive/QAE.
Number of Plastic spoon, Plastic dropper and check hologram At the beginning
6. At least 5 pcs.
stickering. Hourly by QAI/ PS and two hourly by Production Executive/QAE.
At the beginning
7. Number of IFC per Master Carton ( 1X12 Packs) At least 5 pcs.
Hourly by QAI/ PS and two hourly by Production Executive/QAE.
4.1.3 Fill up the following table for updating BPR:

Use () for OK, (X) for Not OK and (-) for Not Applicable.
Page 12 of 17
APEX PHARMA LIMITED

Batch No. :
Batch No.: Mfg. Date: Exp Date: MRP Tk:
Batch. Checked by
No., Mfg. Label Bottle No. of Print
Batch. No., Mfg. Alignmen placed in Plastic Plastic
Time Date, Exp. Hologra IFC/ on
Date Date, Exp. date, t & fixing right way Leafle Spoon Dropper
(AM/PM) Date & m Master Master PS/QAI PE QAE
MRP, Text on IFC on bottle t 5 ml 5ml
Text on Carton Carton
Label
4.1.4 No. of Sample Taken by QA: Retention: ________________Stability: _________________Others: ______________ (For )
Sign and Date
4.4 Job Allocation Data Sheet:
Fill up the following tables for updating BPR:
Page 13 of 17
APEX PHARMA LIMITED

Batch No. :
Time
Recorded By
Date Operation Operator ID No. Total Man Hour
(TL/PS)
Start End
Overprinting
(Label / IFC)
Labeling
Leaflet Folding
Bottle & Leaflet

Insertion
Dropper Insertion
Spoon Insertion
Page 14 of 17
APEX PHARMA LIMITED

Batch No. :
Time
Recorded By
Date Operation Operator ID No. Total Man Hour
(TL/PS)
Start End
IFC Closing
Hologram Fixing on
IFC
Shipping Carton
closing and Labeling
Total Man Hour
Grand Total Man Hour: _____________Hours; Done by (PS): ______________; Checked By (Production executive.): _______________
4.5 Reconciliation of Finished Goods
Type of Yield Quantity (Nos.) Equivalent Commercial Packs
Page 15 of 17
APEX PHARMA LIMITED

Batch No. :
Theoretical yield at Manufacturing Stage (as packs) _____________________ = A
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 packs) ______________________ = G
In-process Reject (as packs) ______________________ = H
[A - (B C D E F G H)] X 100
Process Loss (%) = ___________________________________________ = (Limit: + 2.00%)
A
(B + C D E F G) X 100
Yield (%) = _________________________________________ =
Theoretica
l batchsize
Recorded by (PS):_____________________ Checked by (PE):_____________________ Checked by (QAE):_____________________
Note: Investigate if the reconciliation is outside the stipulated limit.
5.0 Note if any deviation, change request, CAPA, OOS regarding the BPR:
6.0 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.
Page 16 of 17
APEX PHARMA LIMITED

Batch No. :
Observed by Observed by
Check List Documents are ok and attached with BPR
(Production Executive) (QA Executive)
In-process Control 1. Line clearance certificate.(Printing, leaflet folding & packing)
Label , IFC & Leaflet 2. With correct batch number, Mfg. Date, Exp. date and MRP
Signature and Date Signature and Date
All the steps are done according to the BPR and if not, deviation / OOS / change request are reported (in step 5.0). All data are recorded properly.
Checked By (PE) ______________ Checked By (QAE): ______________
7. 0 Production Comments:
Production Approval: ________________
8. 0 QA Comments:
QA Approval: ______________________
9.0 Revision History
Version
Date Doc. No. Reason for Revision
No.
14.09.201
BPR/FP026-01 01 First time issued in new format for packaging of azinil 35 ml PFS with bitter masked formulation.
2
Page 17 of 17

BPR - FP025-1 V-1Azinil 35ml PFS

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APEX PHARMA LIMITED

Shafipur, Gazipur, Bangladesh

BATCH PACKAGING RECORD (BPR)

MFG. DATE: EXP. DATE: Issued by: Signature & Date

Approval of Current Version of the Document

Checked by Md. Khosruzzaman Sr. Executive -QAD

Agreed by Md. Saiful Islam Production Manager

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

1.0 Process Details:

2.1 Dispensing Procedure:

BATCH PACKAGING RECORD (BPR)

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

2.2 Receiving Procedure:

Dispensing Order (Standard)

Sl. No. Item Code Name of Materials Unit Standard Quantity

01 PM00101 Azinil PFS-35 ml Carton Nos. 2800 pcs

02 PM00106 Azinil PFS-35 ml Label Nos. 2800 pcs

03 PM00104 Azinil Leaflet for PFS Nos. 2750 pcs

04 PM00377 Plastic Spoon 5 ml Nos. 2850 pcs

05 PM00376 Plastic Dropper 5 ml Nos. 2850 pcs

06 PM00167 Dozon Box Azinil PFS 35 ml Nos. 225 pcs

07 PM00054 Apex Hologram Sticker Nos. 2850 pcs

Dispensing Order for this Batch/Presentation

BATCH PACKAGING RECORD (BPR)

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

Name of M.R.R.No consume + By By (WH)

BATCH PACKAGING RECORD (BPR)

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

Stability + Quantit Checked by

Name of M.R.R.No consume By

Name of M.R.R.No consume + By

BATCH PACKAGING RECORD (BPR)

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

Name of *Projected M.R.R.No QC Ref Stability By

Name of *Projected M.R.R.No QC Ref Stability By Received

BATCH PACKAGING RECORD (BPR)

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

Name of *Projected M.R.R.No QC Ref Stability By

Name of M.R.R.No./ By Received

BATCH PACKAGING RECORD (BPR)

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

Item Acceptance Criteria Production Executive QA Executive

Batch No. Signature & Date Signature & Date

BATCH PACKAGING RECORD (BPR)

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

Manufacturing Date: MMM- YY

Expiry 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.

3.1.1 Line Start-Up Record:

BATCH PACKAGING RECORD (BPR)

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

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)

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

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

Batch No., Mfg. Checked by

4.0 Secondary Packaging Operation:

4.1 Operation Labeling & Packing:

BATCH PACKAGING RECORD (BPR)

Recorded by (PS):___________ Checked by (PE):_ Checked by (QAE):___________

Checked By (PE) Checked By (QAE):