ALCO PHARMA LTD.

Batch Packaging Record

MIRPUR, DHAKA, BANGLADESH
Product Name: Emiset Oral Solution 50 ml MA No. : 272-263-018
Generic Name: Ondansetron Hydrochloride USP Product Code: LIQ-E-007 Mfg. License No.: 193 & 430
Label Claim: Each 5 ml oral solution contains Ondansetron Hydrochloride USP Description: A yellow transparent syrup. Free from visible impurities.
equivalent to Ondansetron 4 mg.
Pack Size: Commercial: 1x1’s (75 ml Pet Bottle with Plastic Cap) Price: IP: 45.00 Tk.
Physician: 1x 1’s (75 ml Pet Bottle with Plastic Cap)
Standard Batch Size: Volume: 500 Liters Unit: 10,000 Phials Commercial Pack: 10,000 Phials Physician Pack: 10,000 Phials
MBR No.: ALCO-BPR- LIQ- E-007.01 Supersedes: BPR- LIQ-E-007 Page 1 of 25
Status Effective Date Effective B. No. CC. No. Shelf Life
Final 04.12.19 12A19 APL-CC-19-B0113 2 Years
Revision History: Revision # 01 BMR Format change:
Batch No.: Mfg. Date: Exp. Date:

Approval Of Batch Packaging Record

Prepared By Sign. Date: Approved By

(Executive, Production) Head of Production Sign. Date:

Checked By Sign. Date:

(Head of PD)
Head of QA Sign. Date:

Verified By Sign. Date:

(Deputy Production
Manager)
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 2 of 25

Batch Packaging Record

QA Reference No. Reviewed By (Executive, QA)
Date
Issued on Closed by (Executive, Prod.)
Date
Issued by Total No of pages after Completion

Product Appearance A yellow transparent syrup. Free from visible impurities

Batch Size Details Yield

Standard Batch Size Actual Batch Size Std. Actual

Liters Phials Liters Phials

Commercial Physician Commercial Physician
98% - 102%
500 Liters 10,000 Phials
Date of
Date of Commencement Cycle Time
Completion

INSTRUCTION
Prepare a packing materials Allocation sheet for packing materials and submit this batch packaging record with allocation sheet to the warehouse for releasing of packing materials.

SAFETY INSTRUCTION
Use protective clothing, cotton mask, Gloves, anti shoes, safety glasses with eye protection shield during material handling.
In case of accidental spillage/release of material collect the spilled material in appropriate container or disposal, keep out of water supplies and sewers, stay away, isolate hazard
area and seal the area for denying entry of any personnel in that area.

FIRST AID MEASURES

Avoid contact with skin, eyes and inhalation and accidental ingestion through mouth.
In case of skin contact washes with soap and water for 15 minutes.
In case of eye contact flush eyes in eye shower with water for 15 minutes.
In case of ingestion get immediate medical attention.
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 3 of 25

DISPENSING
Check Prior to Received materials (put √ in each points)

 All materials affixed with proper approval labels (PASSED labels) of QC.
 Check cleanliness of each relevant materials
 Ensure the no. of defects are found in the carton
 Ensure the correct product materials received
 Correct materials of sufficient amount as per Packaging Order Sheet (POS)
 Dispensing information should be properly recorded and signed in Packaging Order Sheet (POS)
 All balances used are calibrated.

Area, Equipments, Utensils/ Accessories Code Cleaned by Date

1. Dispensing Area Not Applicable
2. Balance
3. Balance

 Ready for Packaging Material Dispensing

Checked by(officer/Ex. WH):…………………… Checked by(Ex, Prod):…………………… Checked by (Ex. QA):…………………

Date:……………………. Date:…………………… Date:………………………
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 4 of 25

Packaging Order Sheet (POS)

Code No. Material Name QC Ref. Standard Issued Quantity Total Reject Return Issued by Received Checked Remarks
No. Quantity 1st 2nd Issued Quantity Quantity Ex. WH by by
Quantity Ex. Prod. Ex. QA

PRIMARY PACKAGING
PM-BTL-75 10000Pcs
Pet Bottle 75 ml
PM-PC-28 Plastic Cap 28 mm 10000Pcs

SECONDARY PACKAGING
PM-IC-LIQ- Inner Carton of Emiset 10000Pcs
E-007 Oral Sol.
PM-LA-LIQ- Label of Emiset Oral 10000Pcs
E-007 Sol.
PM-IN-LIQ- Literature of Emiset 10000Pcs
E-042 Oral Sol.
PM-SPN-5 5 ml Plastic Spoon 10000Pcs
PM-SC-03 Master Carton #3 80Pcs
PM-HS-01 Hologram 10000Pcs
PM-GT-02 Gum Tape 02 Pcs

Date Dispensed: Time Started: Time Ended: Total Time Required:

Distribution of Batch Size

 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 5 of 25

Checked by Approved by
Sr.# Stage Quantity in Kg Equivalent. No. of Phials Date
Ex./Sr.Ex., Production Ex./Sr. Ex., QA
1. Commercial
2. Physician Sample
3. Govt./ Institutional supply
Total

STAGE: BOTTLE WASHING

BOTTLE WASHING (ROOM NO: ) LINE CLEARANCE

Previous Product Name Batch No. Cleaned By Checked by Checked by
(Ex./Sr.Ex., Prod.) (Ex./Sr. Ex., QA)

AREA CLEARANCE
Sl. Parameters to be checked Yes No NA Checked by Checked by
No. (Ex./Sr.Ex., Prod.) (Ex./Sr. Ex., QA)
1. Ensure that the washing machine is properly cleaned.
2. Ensure that Purified water & Potable water line are specified.
3. Ensure that all personnel have worn cleaned factory uniform and PPE
4. Adequate lighting is available to carry out the job.
5. Ensure that correct bottles have been received

EQUIPMENT CLEANRANCE
Sl. No. Equipment Name ID No. Yes No NA Checked by Checked by (Ex./Sr.
(Ex./Sr.Ex., Prod.) Ex., QA)
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 6 of 25

1. Bottle Washing Machine APL-PN-BW-001

LINE CLEARANCE DONE BY

OPERATOR NAME ID NO SIGN DATE

CONCLUSION Area is cleaned/Not cleaned for operation Ex./Sr.Ex., Prod. (Sign/Date) Time:
Area is cleaned/Not cleaned for operation Ex./Sr. Ex., QA(Sign/Date) Time:

BOTTLE WASHING

1. Collect the bottle from Warehouse and keep in holding area.

2. Perform de-boxing and place in machine holder
3. Run the machine and start washing with potable and Purified Water.
4. Aligned wash bottles in drying tray.

BOTTLE WASHING OPERATION

DATE START TIME END TIME ACTUAL TIME

Checked the cleanliness of bottle by: Ex./Sr.Ex., Prod. (sign & date) ______________ Ex./Sr. Ex. QA (sign & date) _____________

STAGE: OVER PRINTING

OVER PRINTING INSTRUCTIONS

  
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 7 of 25

1. Remove all printed packing material of previous batch from the line. Checked By
Ex./Sr.Ex. Ex./Sr.Ex.
2. Check the Item code (Artwork code) as per Material Issue Order.
Prod. QA
3. Take line clearance from QA and document the same.
4. Production supervisor to check the coding details as under on the Specimen sample and QA inspector to verify the same.
5. Attach the checked printed specimen sample with the BMR.

6. Collect the rubber stereos/letters from shift in charge and check against Overprinting instructions.
7. After completion of coding, destroyed the used and unused rubber stereos by cutting two to three pieces and in case of letter,
remove the letters from printing head and store under lock and key .
8. In process check should be performed every two hours interval

A rea/E q u ip men t Lin e C learan ce

Previous Product: __________________________________ Batch No.__________________________

Sr. Equipment name Equipment Number Date Cleaned by Checked By

No.
Ex./Sr.Ex. Prod. Ex./Sr.Ex. QA
1. Nunach Over printing Machine APL-PN-CP-001

BATCH PRINTING REQUISITION

Product Name : Batch No. :

Generic name : Strength :
Pack Size (Commercial) : IP :
Pack Size (Physician) :
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 8 of 25

The Following Information are printed in the Required Inner carton & Label
For Commercial For Physician Sample / Govt. / institutional
Batch No. : Batch No. :
Mfg Date : Mfg Date :
Exp. Date : Exp. Date :
Price IP :

ATTACHED SPECIMEN

ATTACHED QA APPROVAL

CONCLUSION Printing carton is approved / Not Approved Ex./Sr. Ex., Production Sign/ Date Time
Printing carton is approved / Not Approved Ex./Sr. Ex., QA Sign/ Date Time

In Process Check During Inner Carton Over Printing

Date
Time
Pack Size
No of Unit Inspected
Checking Parameters
Batch No: C/NC
Mfg Date: C/NC
Exp Date: C/NC
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 9 of 25

Price ( if applicable) C/NC

Print Quality C/NC
Alignment C/NC
Operator
Remarks
Checked by (Ex. / Sr. Ex. Prod.)
C=Complies, NC= Not Complies

Personnel Involved of Inner Carton Overprinting Operation

Activity Name Activity Name
1. 1. 1.
Carton Carton
2. 2. 2.
Overprinting Sorting
3. 3. 3.

Duration & Quantity of Overprinting

Date: Date: Date: Date: Date: Date:
From To From To From To From To From To From To

Qty:

Quantity Received Sample Defective Damage during printing Quantity Ready for use

Received By ( Supervisor) Sign & Date: Checked By: Ex. / Sr. Ex. Prod. Sign & Date:

STAGE: LITERATURE FOLDING

Folding Start-up
The Following information are required:
Released to start-up Inner Literature
Date Checked By
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 10 of 25

Time Ex. / Sr. Ex. Prod. Ex. / Sr. Ex. QA

No. of Inner Literature folding

Attach the Approved folded inner literature here:

Signed & Approved folded inner literature

Checking During Literature Folding Operation

Date
Time
No of Unit Inspected
Checking Parameters
Inner Literature
C/NC
Code: PM-IN-LIQ-T-021
No of folds C/NC
Folding Alignment C/NC
Operator
Remarks
Checked by (Ex. / Sr. Ex. Prod.)
C=Complies, NC= Not Complies

Personnel Involved of Literature Folding Operation

Activity Name
Inner Literature 1. 2.
Folding 3. 4.
Duration & Quantity of Literature Folding Operation

Date: Date: Date: Date: Date: Date:

From To From To From To From To From To From To

Qty:
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 11 of 25

Quantity Received Sample Defective Damaged during folding Quantity Ready for use

Received By ( Supervisor) Sign & Date: Checked By: Ex. / Sr. Ex. Sign & Date:
Prod.

STAGE: FILLING & 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. Check labels of the materials before using.
4. Ensure that the line clearance checklist and CLEANED TAG are signed by Ex./Sr.Ex., Prod. and Ex./Sr.Ex., QA.
FILLING & SEALING (ROOM NO. ) LINE CLEARANCE

Previous Product Name Strength Batch No. Cleaned By: Date Checked by:
Operator Ex./Sr.Ex., Prod.

AREA CLEARANCE
Sl No Parameters to be checked Yes No NA Checked by Checked by
(Ex./Sr.Ex., Prod.) (Ex./Sr.Ex., QA)
1. Floor
2. Wall
3. Ceiling Surface
4. Door
5. Room Control (Temperature & Humidity)

EQUIPMENT CLEANRANCE
Sl. No. Equipment Name ID No Yes No NA Checked by Checked by
(Ex./Sr.Ex., Prod.) (Ex./Sr.Ex., QA)
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 12 of 25

1. Auto Liquid Filling & Sealing Machine APL-PN-LP-001

2. SS Vat Not Applicable
3. Scoop Not Applicable

LINE CLEARANCE DONE BY

OPERATOR NAME ID NO SIGN DATE

CONCLUSION Area is cleaned/Not cleaned for operation Ex./Sr.Ex., Prod.( Sign/Date) Time:
Area is cleaned/Not cleaned for operation Ex./Sr.Ex., QA ( Sign/Date) Time:

FILLING & SEALING MACHINE SETTING

Machine assembled by Bottle & Cap Sealing Bottle & Cap Sealing checked by Machine setting checked by Date
Done by Ex./Sr.Ex., Prod. Executive, Maintenance

 Properly labeled and correct materials in accordance with BPR.

 No. Vat of syrup: Seal found:

 Temperature:_________________ C 0
(Limit: Not More Than 250C)

 Humidity: ___________________%RH. (Limit: Not More Than 50%RH)

 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 13 of 25

MACHINE ADJUSTMENT

Date Cap Sealing Cap Tight Leak Test of Empty Avg. Filling Volume Tested By Checked by
Sealed Bottle (5 Bottle) (Ex./Sr.Ex., Prod.)

Set the Filling & Sealing machine as per following specification. Fill and seal a full run according to following specification and inform QA for checking of Filling & Sealing start-up.

Initial Parameter Checking Record (During initial machine setting) Test Date:________________ Test time_______________

Parameter Results Parameter Results Specification

Line-1 Line-2 Line-3 Line-4 Line-5 Line-6 Line-7 Line-8 *Appearance Appearance: A yellow transparent syrup. Free from visible
impurities
Individual
pH pH: 3.5 to 4.5
fill Volume
(ml) of 16 Theoretical fill Volume (ml): 50 ml
Line-1 Line-2 Line-3 Line-4 Line-5 Line-6 Line-7 Line-8 *Leak test
bottles
From 8 *Sealing Ind. Fill Volume (ml): (__________ to _________)
different [0% to + 2% of the theoretical Fill Weight]
nasal
*Visible
foreign Leak test: Bottle sealing must leak proof.
Min. fill particle Visible foreign particle: free from foreign particle.
Temp. (0C)
Vol. (ml)
Max. fill
RH (%)
Vol. (ml)
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 14 of 25

Remarks:

Analyzed by: Ex./Sr.Ex., Prod. (Signature & Date): ____________________ Checked by: Ex./Sr.Ex., QA (Signature & Date): ______________________

 Start Filling & Sealing after getting clearance from QA. Collect the sample for in-process check.
 Record the in-process result in in-process monitoring sheet.
 Inform QA for taking sample and send sample to QC for analysis & keep record on Filling & Sealing yield page.

Parameters Checking Frequency

Sl. No. In process Checks Frequency
1 Appearance At the beginning & Half Hourly by Operator and Hourly Production Executive, QA Executive / Inspector.
2 Sealing At the beginning & Half Hourly by Operator and Hourly Production Executive, QA Executive / Inspector.
3 Visible Foreign Particle At the beginning & Half Hourly by Operator and Hourly Production Executive, QA Executive / Inspector.
4 Filled Weight At the beginning & Half Hourly by Operator and Hourly Production Executive, QA Executive / Inspector.

Record the Room Condition during Filling & Sealing of the batch. Record the Room Condition 1 hour interval
Date Time Temperature Humidity Checked by
(Limit: NMT 25oC) Limit: (NMT 50%) Ex./Sr.Ex., Prod. Ex./Sr.Ex., QA
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 15 of 25

In-Process parameter checking record

Sampling Time and
Product Specification
Date
Parameter

L-1 L-1 L-1 L-1 L-1 L-1 L-1 L-1 Appearance: A yellow transparent syrup.
Free from visible impurities
L-2 L-2 L-2 L-2 L-2 L-2 L-2 L-2
L-3 L-3 L-3 L-3 L-3 L-3 L-3 L-3
Individual fill L-4 L-4 L-4 L-4 L-4 L-4 L-4 L-4
Parameter

Volume (ml) from 8 Theoretical Fill Vol. (ml): 50 ml

Lines L-5 L-5 L-5 L-5 L-5 L-5 L-5 L-5
L-6 L-6 L-6 L-6 L-6 L-6 L-6 L-6 Ind. Fill Vol. (ml):

L-7 L-7 L-7 L-7 L-7 L-7 L-7 L-7 (__________ to __________)
L-8 L-8 L-8 L-8 L-8 L-8 L-8 L-8
Max. Fill Vol.
Leak test: Bottle sealing must leak
Min. Fill Vol. proof.
Avg. Fill Wt. (gm) Visible foreign particle: free from
foreign particle.
% Deviation (+)
% Deviation (-) Note:
* Appearance * Put (√) for 'ok', (x) for 'not ok' and (-) for
*Sealing 'not applicable'.
*Visible foreign Remarks:
particle particle
Done by
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 16 of 25

Checked By:
Ex./Sr.Ex., Prod.
/QA

In-Process parameter checking record

Sampling Time and
Product Specification
Date
Parameter

L-1 L-1 L-1 L-1 L-1 L-1 L-1 L-1 Appearance: A yellow transparent syrup.
Free from visible impurities
L-2 L-2 L-2 L-2 L-2 L-2 L-2 L-2
L-3 L-3 L-3 L-3 L-3 L-3 L-3 L-3
Individual fill L-4 L-4 L-4 L-4 L-4 L-4 L-4 L-4
Parameter

Volume (ml) from 8

Lines L-5 L-5 L-5 L-5 L-5 L-5 L-5 L-5 Theoretical Fill Vol. (ml): 50 ml
L-6 L-6 L-6 L-6 L-6 L-6 L-6 L-6
Ind. Fill Vol. (ml):
L-7 L-7 L-7 L-7 L-7 L-7 L-7 L-7
L-8 L-8 L-8 L-8 L-8 L-8 L-8 L-8 (__________ to __________)
Max. Fill Vol.
Min. Fill Vol. Leak test: Bottle sealing must leak
Avg. Fill Wt. (gm)
proof.
Visible foreign particle: free from
% Deviation (+) foreign particle.
% Deviation (-)
* Appearance Note:
*Sealing * Put (√) for 'ok', (x) for 'not ok' and (-) for
'not applicable'.
*Visible foreign
particle particle Remarks:
Done by
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 17 of 25

Checked By:
Ex./Sr.Ex., Prod.
/QA

In-Process parameter checking record

Sampling Time and

Product Specification
Date
Parameter

L-1 L-1 L-1 L-1 L-1 L-1 L-1 L-1 Appearance: A yellow transparent syrup.
Free from visible impurities
L-2 L-2 L-2 L-2 L-2 L-2 L-2 L-2
L-3 L-3 L-3 L-3 L-3 L-3 L-3 L-3
Individual fill L-4 L-4 L-4 L-4 L-4 L-4 L-4 L-4
Parameter

Volume (ml) from 8 Theoretical Fill Vol. (ml): 50 ml

Lines L-5 L-5 L-5 L-5 L-5 L-5 L-5 L-5
L-6 L-6 L-6 L-6 L-6 L-6 L-6 L-6 Ind. Fill Vol. (ml):
L-7 L-7 L-7 L-7 L-7 L-7 L-7 L-7 (__________ to __________)
L-8 L-8 L-8 L-8 L-8 L-8 L-8 L-8
Max. Fill Vol.
Leak test: Bottle sealing must leak
Min. Fill Vol. proof.
Avg. Fill Wt. (gm) Visible foreign particle: free from
foreign particle.
% Deviation (+)
% Deviation (-) Note:
* Appearance * Put (√) for 'ok', (x) for 'not ok' and (-) for
*Sealing 'not applicable'.
*Visible foreign
Remarks:
particle particle
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 18 of 25

Done by
Checked By:
Ex./Sr.Ex., Prod.
/QA

Secondary Packaging Operation

Pre-Packaging checklist
Instructions:
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.
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.
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
Date & Time Date & Time Date & Time Date & Time

Line Clearance Line Clearance Certificate is valid &

Certificate signed by QA.
Current product’s name, Mfg date, Exp
Display date & batch no. are being displayed at  Belt  Belt  Belt  Belt
Conveyer Belt.
Packing Type Secondary packing is being performed  Commercial  Commercial  Commercial  Commercial
(only one) as:  Physician  Physician  Physician  Physician
Remarks:
Signature Production Executive:
QA Executive:

Secondary Packaging Operation Check Specification

Sl. No. of sample

In- process Check Frequency
No. (Each time)
B. No., MFG. Date, EXP. Date, IP, Text on Inner Carton and B.
1. At least 5 pcs. At the beginning & Hourly by QAI and two hourly by Production Executive/QAE.
No., MFG. Date, EXP. Date, IP, Text on Label
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 19 of 25

2. Print on Master Carton Label At least 5 pcs. At the beginning & Hourly by QAI and two hourly by Production Executive/QAE.
Number of Phials per IFC and Number of Inner Carton per
3. At least 5 pcs. At the beginning & Hourly by QAI and two hourly by Production Executive/QAE.
Shipper Carton
4. Text on Inner Carton and Literature At least 5 pcs. At the beginning & Hourly by QAI and two hourly by Production Executive/QAE.
5. Quantity (1) phial/ Inner Carton; Inner Carton / Shipper Carton) At least 5 pcs. At the beginning & Hourly by QAI and two hourly by Production Executive/QAE.

INPROCESS CHECK DURING PACKAGING:

Date & Time

Appearance
Cleaning of the filled Bottle
Labeling
Inserting Literature
Insertion of measuring Plastic Spoon
Folding Carton
Batch No. Printing
Mfg. Date
Exp. Date
MRP/IP
Hologram Sticker
Checked By: Ex./Sr.Ex. Prod./QA
INPROCESS CHECK DURING PACKAGING:
Date & Time

Appearance
Cleaning of the filled Bottle
Labeling
Inserting Literature
Insertion of measuring Plastic Spoon
Folding Carton
Batch No. Printing
Mfg. Date
Exp. Date
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 20 of 25

MRP/IP
Hologram Sticker
Checked By: Ex./Sr.Ex. Prod./QA

INPROCESS CHECK DURING PACKAGING:

Date & Time

Appearance
Cleaning of the filled Bottle
Labeling
Inserting Literature
Insertion of measuring Plastic Spoon
Folding Carton
Batch No. Printing
Mfg. Date
Exp. Date
MRP/IP
Hologram Sticker
Checked By: Ex./Sr.Ex. Prod./QA

INPROCESS CHECK DURING PACKAGING:

Date & Time

Appearance
Cleaning of the filled Bottle
Labeling
Inserting Literature
Insertion of measuring Plastic Spoon
Folding Carton
Batch No. Printing
Mfg. Date
Exp. Date
MRP/IP
Hologram Sticker
Checked By: Ex./Sr.Ex. Prod./QA
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 21 of 25

ENVIRONMENTAL CONTROL
Room No: Temperature: Not More Than 25oC ; Relative Humidity : Not More Than 50%
Frequency: Record 1 hour interval.
Location:

Date Time Temperature % RH Checked by

Ex. Prod. EX. QA

PERSONS INVOLED IN PACKAGING

Action performed Date Name of Personnel ID No.
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 22 of 25

Bottle Wash

Bottle Filling
Filled Bottle Checking

Labeling & Label Checking

Inner Carton

Packing with Literature

Plastic Spoon

Hologram

Master Carton

RECONCILIATION OF PACKING MATERIALS

Bottle/Show Boxes/Inserts/Corrugated Boxes/Sticker/Shipper label (For Sales Pack)

Secondary Packing Materials Reconciliation Sheet (SPMRS)

 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 23 of 25

Code No. Material Name Standard Qty. Wastage Std.

Quantity Total qty Qty. Specimen Actual % Wastage
Returned To in Nos. %
Received Packed sample Consumption G=(FX100)
PMS F=(A-B- Wastage
A B C E=(A-D) A
D C-D)
SECONDARY PACKAGING
PM-BTL- Pet Bottle 75 ml 5.00
75
PM-PC-28 Plastic Cap 28 mm 5.00

PM-IC- Inner Carton of 5.00

LIQ-E-007 Emiset Oral Sol.

PM-LA- Label of Emiset 2.00

LIQ- E- Oral Sol.
007
PM-IN- Literature of Emiset 2.00
LIQ- E- Oral Sol.
042
PM-SPN-5 5 ml Plastic Spoon 2.00

PM-SC-03 Master Carton #3 5.00

PM-HS-01 Hologram 1.00

Accountability Checked By

Ex. Prod. Sign & Date: Ex. QA Sign & Date:

RECONCILATION/ YIELD ANALYSIS
Finished Goods Transfer Details

Date Pack Size Total Sales Pack Transfer Total Physician Sample Done By Checked By
Pack Transfer Packing Supervisor Ex./Sr.Ex. Prod. Ex./Sr.Ex. QA
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 24 of 25

Reconcile the quantity of finished product recovered from manufacturing with material and find out any major deviation in yield or consumption, if any and record it.
Theoretical Qty. Actual Qty. (B) Sample taken Waste (D) Accountability Yield Rate
(Phials) (A) Commercial Physician (Analytical + Retention) [(B+C+D)×100]/A [(B+C)×100] /A
(C)

Reconciliation A – (B+C+D) X 100

% of unaccountable loss = ------------------------------ = ------------------------------------------
=
A

01. Limit: 98% - 102% of theoretical Yield

02. If the actual yield is beyond the above limit, a “failure Investigation” is to be made and an explanation must be given below.
Explanation:

Prepared By Checked By Reviewed by Approved By

Packing Supervisor Ex./ Sr. Ex. Production Ex./ Sr. Ex. QA Production Manager QA Manager

Packaging Order Sheet (POS)

Code No. Material Name QC Ref. Standard Issued Quantity Total Reject Return Issued by Received Checked Remarks
No. Quantity 1st 2nd Issued Quantity Quantity Ex. WH by by
Quantity Ex. Prod. Ex. QA

PRIMARY PACKAGING
 ALCO PHARMA LTD. Batch Packaging Record
MIRPUR, DHAKA, BANGLADESH Approved By
Head of Prod. Head of QA
Product Name Batch No. B.Size Mfg.Date Exp.Date Page No.
Emiset Oral Solution 50 ml 10,000 Phials Page 25 of 25

PM-BTL-75 10000Pcs
Pet Bottle 75 ml
PM-PC-28 Plastic Cap 28 mm 10000Pcs

SECONDARY PACKAGING
PM-IC-LIQ- Inner Carton of Emiset 10000Pcs
E-007 Oral Sol.
PM-LA-LIQ- Label of Emiset Oral 10000Pcs
E-007 Sol.
PM-IN-LIQ- Literature of Emiset 10000Pcs
E-042 Oral Sol.
PM-SPN-5 5 ml Plastic Spoon 10000Pcs
PM-SC-03 Master Carton #3 80Pcs
PM-HS-01 Hologram 10000Pcs
PM-GT-02 Gum Tape 02 Pcs

Requisition Given By : (Production) Requisition Received By :

(Ware House)