Batch No.: XXXXX Part No.

: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 1 of 14

Company Name

Batch Production Record

Batch Number: XXXXX

Part Number: 103982

Part Description: Melatonin Tablet

Scrap:
DOM:
DOE:
Theoretical Quantity: 300,000 Tablets

Prepared By (Signature) Date (MM/DD/YY)

Quality Control – Approved (Signature) Date (MM/DD/YY)

APPROVED COPY (Blue Color Only)

Possession of this document is an acknowledgment that all contents herein are the exclusive property of _______ Health Sciences, Inc. The contents may not be reproduced in any form without written permission
from _______ Health Sciences, Inc. The possessor must ensure they have the most current revision.

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 Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 2 of 14

DISPENSING PROCESS – Manual Weighing System

The Manual Weighing System is only to be used if the approved electronic weighing system is not available, otherwise do not complete this portion of the BPR.  
Production Management must be notified prior to dispensing using the Manual Weighing System and a deviation must be submitted to the Quality Department.  
Follow the steps below in conjunction with the applicable operating policies and procedure to operate using the Manual Weighing System:
Start Time: Start Date:
(HH:MM in 24 hour format) (MM/DD/YY)

Deviation Number:
Supervisor: Date:
(Signature) (MM/DD/YY)

1. Inventory is released from quarantine, approved for use, and contains appropriate status indication.
2. Weigh listed ingredients to obtain required amount.
3. Place dispensed material in clean polyethylene bags and into clean containers.
4. Record required information on this batch record and weigh tags.
5. Attach weigh tag to dispensed ingredients.
6. Another Manufacturing Technician must independently verify weights and recorded information on batch record and weigh tags.
Receiving
Part Part Net Weighed Verified
Actual Number
Item U/M Scale No.
Weight (Place / between By By
Number Description Weight multiple numbers) (Initial) (Initial)

1 102312 Melatonin Kg
2 128934 Fructose DC Kg
3 195033 Colloidal Silicon Dioxide Kg
4 139203 Nat Orange Flv 3811 SD Kg
5 120324 Ascorbyl Palmitate Kg
7. Move dispensed material to blending staging area when completed
End Time: End Date:
(HH:MM in 24 hour format) (MM/DD/YY)

Additional Comments

Completed By: Date:

(Signature) (MM/DD/YY)
Verified By: Date:

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 (Signature) (MM/DD/YY)
Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 3 of 14

PRE-BLENDING PROCESS
1. Complete “Pre-line Clearance - Pre-Blend Dispensing.”
2. QC or MFG Management must independently verify “Pre-line Clearance - Pre-Blend Dispensing” before the pre-blending process can begin
Pre-line Clearance - Pre-Blend Dispensing
QC/MFG
Item Description Checked By Management
(Initial) Verified By:
(Initial)

1 Record dispensing room number to be used.

Room Number:

2 Record previous batch description and number.

Previous Batch/Number:
Equipment and tools (Utensils) are clear of debris, product residue, etc. (Items are re-sanitized when visual
3
inspection indicates a need.
4 Room is clean and ready for use?

5 Room status indicates “Ready for Use” in green color?

6 Update “Activity Log.”

7 Scales are calibrated, functional, and ready to use?

Completed By: Date:

(Signature) (MM/DD/YY)

QC/MFG Management Verified By: Date:

(Signature) (MM/DD/YY)

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 Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 4 of 14

BLENDING PROCESS - PRE-BLEND 1

1. Follow all applicable blending and barrel policies and procedures.
2. Label an applicable clean barrel as “Pre-Blend 1”.
3. Stage following ingredients in applicable dispensing or loading room.
4. Another Manufacturing Technician must independently verify the staged material weights and recorded information on batch record and weigh tags.
5. Another Manufacturing Technician must independently verify ingredients as they are loaded.
6. Load Pre-blend barrel in order of sequence as listed in the batch production record.
7. Batch Record and Weigh tags are verified by Production Management after blending process to ensure all materials have been added to the batch.

PRE-BLEND 1

Item Part Number Part Description Weight U/M Staged By Checked By Loaded By Checked By
(Initial) (Initial) (Initial) (Initial)

1 195033 Colloidal Silicon Dioxide Kg

2 139203 Nat Orange Flv 3811 SD Kg
3 102312 Melatonin Kg
4 128934 Fructose DC Kg

8. Seal barrel with a lid and ring.

9. Place identification tags on barrels and record Actual Net Weight.
Theoretical Weight: Actual Net Weight:
35.92 Kg
(x.xx Kg) (x.xx Kg)

10. Ensure drum roller is calibrated, functional, clean, and ready for use.
11. Update Activity Log.

12. Record drum roller equipment number

Equipment Number:

13. Rotate barrel in the drum roller for 15 minutes.

Start Time: End Time: Date:

(HH:MM) (HH:MM) (MM/DD/YY)

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 Completed By:
(Signature)
Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 5 of 14

DISPENSING & BLENDING RECONCILIATION

1. Record Gross and Tare Weights.
2. Calculate Actual Net Weight.
Gross Weight Tare Weight Net Weight
Bag Number
(x.xx K g) (x.xx Kg) (x.xx Kg)

1
2
3
4
5
6
Theoretical Weight: Actual Net Blended Weight:
99.46 Kg
(xxx.xx Kg) (x.xx Kg)

Color Verification: PASS FAIL

Completed By: Date:
(MM/DD/YY)
(Signature)
Verified By: Date:
(MM/DD/YY)
(Signature)

3. Calculate total loss from blending process as follows:

1. Total Blending Loss: (%) Acceptable Limit: 98.96 Kg to 99.46 kg
1. (Theoretical Weight - Actual Net Weight) x 100 = Percent Loss
Theoretical Weight
*Note: Notify Production Management of color verification Failure
2. Total Blending Loss: (Kg)
2. Theoretical Weight - Actual Net Weight =Total Blending Loss (Kg)
Completed By: Date:

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 (Signature) (MM/DD/YY)

Supervisor/Lead: Date:
(Signature) (MM/DD/YY)
*Note: An investigation and deviation number must be recorded in this Batch Production Record if the “Total Blending Loss” is
more than 0.5%, or the resulting “Actual Net Weight” is greater than the “Theoretical Weight.”
QC/MFG Management Verified By: Date:
(Signature) (MM/DD/YY)

Batch No.: XXXXX Part No.: 103982

Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 6 of 14

TABLET COMPRESSION PROCESS

1. Follow appropriate policies and procedures for setting-up and operating the feed frame, tablet press, and testing equipment.
2. Complete “Pre-line Clearance - Tablet Compression.”
3. QC or MFG Management must independently verify “Pre-line Clearance - Tablet Compression” before the tablet compression process can begin.
QC/MFG
Pre-line Clearance - Tablet Compression Management
Checked By Verified By:
Item Description (Initial) (Initial)
1 Record tablet compression room number to be used.
Room Number:
2 Record tablet press equipment number.
Press Number:
3 Record tool set equipment number and type.
Tool Set Number and Type:
4 Record previous batch description and number.
Previous Batch/Number:
5 Record metal detector equipment number.
Metal Detector Number:
6 Verify tablet shape and punch set.
Tablet Shape: X-SMALL Upper Punch: BISECT Lower Punch: PLAIN
7 Tablet press and tool set are properly installed and functioning?
8 Dust collection system hose is disconnected from tablet press?
9 Room is clean and ready for use?
10 Room status indicates “Ready for Use” in green color?
11 Update “Activity Log.”
12 Testing equipment is calibrated, functional, and ready to use?
Equipment and tools (Utensils) are clear of debris, product residue, etc. (Items are re-sanitized when
13
visual inspection indicates a need.
Completed By: Date:
(Signature) (MM/DD/YY)

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 QC/MFG Management Verified By: Date:
(Signature) (MM/DD/YY)

Batch No.: XXXXX Part No.: 103982

Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 7 of 14

4. Stage blended powder on feed frame to flow into tablet press.

5. Place a clean stainless steel pan to capture compressed tablets at discharge lane.
6. Set-up clean plastic containers lined with polyethylene bags for acceptable tablets and determine “Tare Weight.”
7. Set-up a clearly marked discard container for nonconforming tablets.
8. Set-up tablet press to achieve the following parameters and test results:
Tablet Parameters Lower Limit Target Upper Limit

Tablet Weight (g) 0.148 g 0.153 g 0.158 g

Hardness (Kp) 6 Kp 8 Kp 10 Kp
Thickness (inches) 0.133” 0.140” 0.147”
Starting Weight (SW) Ending Weight (EW) Percent Loss
Target *
(x.xx gm) (x.xx gm) (SW - EW ) / SW x 100 =

Friability Data: ≤ 1%
Color Verification: PASS FAIL
Completed By: Date:
(Signature) (MM/DD/YY)
Verified By: Date:
(Signature) (MM/DD/YY)
*Note: If the friability results are doubtful, or if the weight loss is greater than the target value, repeat friability test twice and average
the three tests. An investigation and deviation number must be recorded in this Batch Production Record.

9. Begin press operations and compress powder into tablets.

10. Record start time and date.
Start Time: Start Date:
(HH:MM in 24 hour format) (MM/DD/YY)

11. Obtain 5 tablets every 30 minutes and check tablet parameters noted on “Tablet Data Sheet” found on pages 21-25
12. Discard tested tablets into appropriate discard container.
13. Record and Plot “Average Tablet Weight” (ATW) on the “Statistical Process Control” (SPC) chart found on pages 26-29.*
14. Make adjustments to the tablet press as necessary based on data from each 30 minute check.
Tablets compressed between 30 minute checks are:
- Placed in plastic-lined containers for later use, if testing results are acceptable

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 - Placed in discard container, if testing results are not acceptable. Increase testing frequency to 10 minutes between checks until passing results
are achieved.
15. Label a small QC sample bag with batch number, part number, and description.
Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 8 of 14

Metal Detector Verification

1.      Follow appropriate policies and procedures for set up and operation of metal detectors.
2.      Only use certified test samples
3.      Operational verification is performed at the beginning of each batch and every hour while the batch is in production.
4.      Another Manufacturing Technician must independently verify recorded information on batch record.

Enter 'P" for Pass or 'F' for Fail Enter 'P" for Pass or 'F' for Fail
Date Time 0.5 FE 0.5 NFE 0.5 SS Blank Initials Date Time 0.5 FE 0.5 NFE 0.5 SS Blank Initials

Enter 'P" for Pass or 'F' for Fail Enter 'P" for Pass or 'F' for Fail
Date Time 0.5 FE 0.5 NFE 0.5 SS Blank Initials Date Time 0.5 FE 0.5 NFE 0.5 SS Blank Initials

Enter 'P" for Pass or 'F' for Fail Enter 'P" for Pass or 'F' for Fail
Date Time 0.5 FE 0.5 NFE 0.5 SS Blank Initials Date Time 0.5 FE 0.5 NFE 0.5 SS Blank Initials

Enter 'P" for Pass or 'F' for Fail Enter 'P" for Pass or 'F' for Fail
Date Time 0.5 FE 0.5 NFE 0.5 SS Blank Initials Date Time 0.5 FE 0.5 NFE 0.5 SS Blank Initials

Enter 'P" for Pass or 'F' for Fail Enter 'P" for Pass or 'F' for Fail
Date Time 0.5 FE 0.5 NFE 0.5 SS Blank Initials Date Time 0.5 FE 0.5 NFE 0.5 SS Blank Initials

Verified By: Date:

(Signature) (MM/DD/YY)

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 Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 9 of 14

TABLET DATA SHEET

Tablet Parameters Lower Limit Target Upper Limit

Tablet Weight (g) 0.148 g 0.153 g 0.158 g

Hardness (Kp) 6 Kp 8 Kp 10 Kp
Thickness (inches) 0.133” 0.140” 0.147”

At a minimum take 5 samples per side at a minimum every 30 minutes for Average Tablet Weight (ATW), Hardness, and Thickness.
Time Hardness Thickness
(HH:MM in 24 Side (Kp) (0.001”) Technician
hour format) (L or R) (Initial)
1 2 3 Average 1 2 3 Average

0.154
0.152
5.9
5.9
0.156
0.153
5.9

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 Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 10 of 14
n=5 Average Tablet Weight (g) = 0.153 Side:
1 0.153 0.157 0.153 0.153 0.157 0.153 0.157 0.153 0.157 0.153 0.157 0.153 0.157 0.153 0.157 0.153 0.157 0.153 0.157 0.153 0.157 0.153
2 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.155 0.153 0.153 0.153 0.153 0.158 0.153
3 0.155 0.153 0.147 0.155 0.153 0.147 0.153 0.147 0.153 0.147 0.153 0.147 0.157 0.147 0.151 0.147 0.153 0.147 0.153 0.147 0.153 0.147
4 0.153 0.148 0.153 0.153 0.148 0.153 0.148 0.153 0.148 0.155 0.148 0.153 0.148 0.153 0.148 0.153 0.148 0.156 0.148 0.153 0.148 0.153
5 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.158 0.153 0.156 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153 0.153
X 0.153 0.153 0.152 0.153 0.153 0.152 0.153 0.152 0.153 0.153 0.153 0.152 0.154 0.152 0.152 0.152 0.153 0.152 0.153 0.152 0.154 0.152
R 0.002 0.009 0.006 0.002 0.009 0.006 0.009 0.006 0.009 0.011 0.009 0.009 0.009 0.006 0.009 0.008 0.009 0.009 0.009 0.006 0.010 0.006

0.158 +3σ

0.157 +2σ

0.156 +1σ

0.153 Target

0.15 -1σ

0.149 -2σ

0.148 -3σ

Pcode
1 2 3 4 5 6 7 8 9 10 11
Rx
0.015

0.0075

0.00
R 0.002 0.009 0.006 0.002 0.009 0.006 0.009 0.006 0.009 0.011 0.009 0.009 0.009 0.006 0.009 0.008 0.009 0.009 0.009 0.006 0.010 0.006

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 ** if recorded notify the lead/mgr for evaluation
Refer to run rules for any SPC Average/Range Chart in supervisor notification page of the BPR
Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 11 of 14
TABLET COMPRESSION PROCESS
1. Record end time and date.
End Time: End Date:
(HH:MM in 24 hour format) (MM/DD/YY)

2. Determine Gross Weight of each container.

3. Record Gross and Tare Weight information on batch record and weigh tags.
4. Attach weigh tags to plastic containers.
5. Calculate Net Weight and record on batch record and weigh tag.
6. Another Manufacturing Technician must independently verify weights and recorded information on batch record and weigh tags.
Barrel Number Gross Weight Tare Weight Net Weight
(x.xx Kg) (x.xx Kg) (x.xx Kg)

10
Actual Net Tablet Weight:
(Kg)
Completed By: Date:
(Signature) (MM/DD/YY)

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 Verified By: Date:
(Signature) (MM/DD/YY)
Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 12 of 14

TABLET COMPRESSION PROCESS

7. Calculate Theoretical Tablet Yield (TTY) and the Actual Tablet Yield (ATY):
Theoretical Tablet Yield (TTY): Actual Tablet Yield (ATY):
Number of Tablets Number of Tablets
(Actual Net Blended Weight in Kg x 1,000) (Actual Net Tablet Weight in Kg x 1,000)
= TTY = ATY
Theoretical Tablet Weight (0.153 g) Theoretical Tablet Weight (0.153 g)

8. Calculate Loss (Kg):

Loss (Kg):

9. Calculate Loss (%): Loss (Kg) x 100

Actual Net Blended Weight (pg.12)
Loss (%):

*Note: An investigation and deviation number must be recorded in this Batch Production Record if the Percent of Loss is more than 5% or the
ATY is greater than TTY.

Supervisor/Lead: Date:
(Signature) (MM/DD/YY)

Additional Comments

Completed By: Date:

(Signature) (MM/DD/YY)

Supervisor/Lead: Date:
(Signature) (MM/DD/YY)

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 Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 13 of 14

BATCH RECONCILIATION

1. Record the following information:

Ending Weight: Kg
Average Tablet Weight (ATW) using SPC data: g
Ending Weight
Total Number of Tablets Produced (TTP): #DIV/0! TTP = x 1,000
(ATW)

2. Calculate % of the Total Batch Loss from tableting process as follows:

(Theoretical Quantity (pg1) - TTP) x 100 = Total Percent (%) Loss

(Theoretical Quantity (pg1)
3. Calculate the Kg Total Batch Loss from tableting process as follows:

(Actual Blended Net Weight (Pg.12) – Ending Weight) = Total loss (Kg)
4. Circle Gain or loss for which is calculated.

Total Loss/ Gain(Kg):

Total Loss/ Gain (%): #DIV/0!

Additional Comments

Completed By: Date:

(Signature) (MM/DD/YY)

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 Batch No.: XXXXX Part No.: 103982
Description: Melatonin Tablet Formula Version: 17A-021
Date Issued: 1/28/2016 Page: 14 of 14

REVIEW AND APPROVAL

6. Record details of any deviation incurred. Assure the Master Deviation Log is updated and reflects any noted deviations.
DEVIATION
(List any known event that does not conform to approved policies, practices, or specifications.)

Deviation Recorded By Released

Number Deviation Date Date
( Written Description) Number
(Initial) (MM/DD/YY) Verified By (MM/DD/YY)

1
2
3
4
5

7. Review all data to ensure accuracy.

REVIEW
(Affirmation denotes that you personally reviewed all information and vouch for the accuracy of all content.)
Supervisor/Lead: Date:
(Signature) (MM/DD/YY)

8. QC completes full document review.

Quality Control – Approved (Signature) Date (MM/DD/YY)

(Green approval stamp)

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