Batch Manufacturing & Packing Record

1. Batch Manufacturing Record (BMR)

Manufacturing Product Details:

Products Details
Product Name: Khadiradi vati खादिरादी वटी
Product Type Oral Tablet Pack Size 10 gm
DDA. Mfg. Lic. No: 3832 Doc. No. SHC/MFR/BMPR/PC-003
Batch No: S003 Batch Size: 10 gm
Manufacturing Date March 2022 Expiry Date 2 years from the date of
manufacturing
Product Start Date 2079-04-01 Ending Date 2079-04-06

Effective Date 2079/04/08 Revision Date One Year

Prepared By Verified By Approved By
(Date & Sign) (Date & Sign) (Date & Sign)
Smriti Shakya Indira Bajracharya Dr Madan Das Tuladhar
2079-04-08 2079-04-08 2079-04-08
Manufacturing Precautions:

- It is necessary to read the contents and thoroughly put into the actual practice.
- Gloves, mask, apron, head cover, safety goggles must be used during all stages of process.
- All area, equipment and auxiliary items are cleaned and checked as per respective SOP.
- All ingredients and WIP bulk product must be kept in cleaned and dry SS container or poly bag.
- Dispensed materials or bulk product should be transfered with cleared identification.
- Progress of Processing and critical aspects must be reported to production in-charge or senior prior
to manufacturing.
- At the end of the day all the semi-finished goods must be stored in air tight container in the proper
area.
- All QC analytical sheet, cleaning sheet should be attached on this BMPR’s respected page.
Label claimed:

Each 100 gm contains:

Khadira Acacia catechu 32gm

Arimeda Acacia leucophloea 64 gm

Karpura Cinnamomum camphora 8 mg

Manjistha Rubia cordifolia 8 mg

Dhataki Woodfordia fructicosa 8 mg

Rasanjana Aqueous extract of berberis 8 mg

aristata
Prapaundarika Nymphea stellate 8 mg
Yashtimadhu Glycyrrhiza glabra 8 mg

Chandana Santalum album 8 mg

Jatamansi Nardostachys jatamansi 8 mg

Haritaki Terminalia chebula 8 mg

Nagkeshar Mesua ferrea 8 mg

Padmaka Prunus puddum 8 mg

Laksha Laciferous lacca 8 mg

Vibhitaki Terminalia bellerica 8 mg

Usheera Veteveria zizanoides 8 mg

Mustak Cyprus rotundus 8 mg

Twak Cinnmomum zeylanica 8 mg

Lodhra Symplocos racemosa 8 mg

Bala Pavonia odorata 8 mg

Ela Elettaria cardamomum 8 mg

Padmak Nelumbium speciosum 8 mg

Gairika Purified red ochre 8 mg

Amalaki Emblica officinalis 8 mg

Anjana Aqueous ext. of berberis 8 mg

aristata
Manjistha Rubia cordifolia 8 mg

Katphala Myrica esculantum 8 mg

Haridra Curcuma longa 8 mg

Daruharidra Berberis aristata 8 mg

Phalini Callicarpa macrophylla 8 mg

Vacha Acorus calamus 8 mg

Yavasa Fagonia cretica 8 mg

Aguru Aquillaria agallocha 8 mg

Pattanga Caesalpinnia sappan 8 mg

Kankola Piper cubeba 32 mg

Jatikosha Myristica fragrans 32 mg

Lavanga Syzigium cumini 32 mg

Nakha Capparis zeylanica 32 mg

 Raw Materials Dispensing Sheet:

Khadiradi vati Mfg. Date: March 2022

Name of Product:
Exp. Date: 2 years from the date of
manufacturing
Batch Size: 100 gm Date of Dispense: 10th March 2022

Batch No: S019 Dispense Time:

1 pm

Performed By Checked By Verified By Approved By

(Sign & Date) (Sign & Date) (Sign & Date) (Sign & Date)
Store Helper Store In-charge Production In-charge QA In-charge

Manufacturing process
Raw herb procurement
Screening,weighing,washing and drying protocol
-Quality of herbs is assured with textual reference
-Once procured, the packed raw material from authorized vendor is inspected.
-The raw material is weighed.
-Then, thorough cleaning is done to make sure they can be processed further.
-After cleaning these herbs are spread in the hot zone so that drying can be assured.
-Later each herb is packed and labelled properly for further processing.

Manufacturing Process- Pulverizing:

Pulverizing Protocol:

- Pulverizer must be cleaned before its use with clean cloth and brush.
- Mixed all the ingredients in a cleaned poly or pvc platform manually. (If necessary)
- Tightly tie the receiver bag on receiver.
- Keep the bulk product on hopper of machine with the limited quantity in each step.
- Run the machine.
- Pass the product gently and collect in a cleaned and dry vessel.
- Tag the identification label and transfer on respected area.

Pulverizing Record of Yield:

Bucket 1 2 3 4 5 6 7 8 Total
No
Net
Weight
(Kg)
Pulverizing Starting Time Pulverizing Ending Time

Performed by Checked by Approved by

Manufacturing Process- Sieving:

Sieving Protocol:

- Keep the product on suitable area for easy handling.

 - Tightly tie the receive bag fixed to the receiver.
- Keep the bulk product on hopper of machine with the limited quantity step by step.
- Run the machine.
- sieve the product gently and collect in a cleaned and dry vessel.
- Tag the identification label and transfer to the respected area.

Sieving Record of Yield:

Bucket 1 2 3 4 5 6 7 8 Total
No
Net
Weight
(Kg)
Sieving Start Time Sieving Ending Time

Performed by Checked by Approved by

Manufacturing process: Decoction

Manufacturing process: Mixing of ingredients with decoction
Making paste
Drying
Compression into tablets

2.Batch Packing Record (BPR)

Packing Materials Dispensing Sheet:

Khadiradi vati Mfg. Date: March 2022

Name of Product:
Exp. Date: 2 years from the date of
manufacturing
Batch Size: 100 g Date of Dispense: 10th March 2022
 Batch No: S019 Dispense Time: 1 pm
Dispensing Record:

SN Name of Materials Lot No Requisition Dispense Qty Remarks

Qty (Pcs) (Pcs)
1 HDPE Container with Cap ………… gm
3 HDPE Container with Cap ………… gm
4 Label of ……………. Gm
6 Label of ……………. Gm
7 Aluminum foil of ………….. gm
9 Aluminum foil of ………….. gm
11 Corrugated Box of …………… gm
12 Corrugated Box of …………… gm
13 Tape ………….. mm
Returned & Rejection Record:

SN Name of Materials Returned Rejection SN Returned Rejection

Qty. Qty (Pcs) Qty. Qty (Pcs)
(Pcs) (Pcs)
2 HDPEContainer with Cap ……… gm 9 Aluminum foil of ……….. gm
3 HDPE Container with Cap …..… gm 10 Corrugated Box of ……… gm
5 Label of ……………. Gm 12 Corrugated Box of ………… gm
6 Label of ……………. Gm 13 Tape ………….. mm
7 Aluminum foil of ………….. gm

Performed By Checked By Verified By Approved By

(Sign & Date) (Sign & Date) (Sign & Date) (Sign & Date)
Store Helper Store In-charge Production In-charge QA In-charge

Packing Process- Filling, Weighing, Sealing & Capping:

Line clearance Check List

 Please tick (√) on below perform and sign.
Room is cleaned after the previous batch product. Performed by Checked by Date
Floor and ceiling are cleaned. (Operator) (QA &
Doors and windows are cleaned. In-charge/Officer) time
All persons are equipped with clean gloves, mask and
apron.
Only required persons are ready to work.
Temperature and Humidity are set as per standard.
Container, Alu. foil, Cap are as per standard & cleaned.
Other usable/Consumable items are cleaned.

Filling, weighing, Sealing & Capping Protocol:

- Take a container and inspect & confirm cleanliness.

- Put the product via spatula as average as 100 gm or ………………….. gm.
- Transfer for weighing.
- Set and tare the weighing balance for required quantity.
- Adjust and fix the required weight and transfer the container for sealing.
- Set the temperature on heat sealer.
- Keep the Aluminum foil and seal gently and transfer the container for capping.
- Take cap and inspect & confirm cleanliness.
- Cap and tight the screw and confirm.
- Keep the product on a crates and transfer on labeling section.

Note out the name list of used

machine, equipment,
consumable etc items like
Heat sealer, Cloth, crates,
Vessel, sweep items etc (If
possible please mention the
quantity, size, model.

Record of Yield:
.................................... gm

Carates 1 2 3 4 5 6 7 8 9 10
No
Net Pcs.
.................................... gm

Carates 11 12 13 14 15 16 17 18 19 20
No
Net Pcs.

Carates 21 22 23 24 25 26 27 28 29 30
No
Net
Pcs.
.................................... gm

Carates 31 32 33 34 35 36 37 38 39 40
No
Net
Pcs.
.................................... gm

Crates 41 42 43 44 45 46 47 88 49 50
No
Net
Pcs.
Job Starting Time Job Ending Time

Performed by Checked by Approved by

Packing Process- Labeling and CB Packing:

Batch Coding Record:

- Set the batch coding machine as content given by QA department.

- Print the label and confirm from QAD.

Batch No:
Manufacturing Date:
Expiry Date:
MRP. Rs.:
No of pcs. Printed
Pasting of sample label approved by QAD
Labeling & CB packing Protocol:

- Take the label and remove the pasting back layer of label gently.
- Label the container with all the details carefully.
- Keep the product on CB until the capacity fulfilled.
- Tape the CB and fill-up content on CB.

Accounted for Process Losses:

Parameters Unit Pcs Converted Unit Unit

kg
(a) Sample issued QA/QC/R&D Kg
(b) Others (If any) Kg
(c) Total a+b Kg
(d) Total Bulk (Actual yield) Kg
(e) Total Consumption (Theoretical weight) Kg

Percentage Reconciliation = ( )
c +d
e
∗100
90 % (±10%)

(If yield reconciliation is out of limit; inform reported person immediately)

Packing completion time; from to

Calculated by Checked by Date & Time

Job Starting Time Job Ending Time

Performed by Checked by Approved by

 Batch Released Certificate
Name of Product: Khadiradi vati

Batch Size: 10 g Batch No: S003

Mfg. Date: March 2022 Exp. Date: 3 years from the date of manufacturing

MRP. Rs.: No of Pcs. Checked.

Average weight CB Taping & Printing Labeling Batch Coding Foil sealing Capping

(Ok or Not Ok)

No of Cartons Released:

…….. gm ………………………… Carton Loose …………………………. Pcs

………gm ………………………… Carton Loose …………………………. Pcs

 Control Sample:

………50…….. 6Pcs.
gm
…………100….. 6Pcs.
gm

CONCLUSION: In the opinion of the under signed, the product referred to above was found to comply/
Does not comply with respect to the specification and hence can be supplied for market.

Released By

…………………………

QAD In-charge

Finished Good Hand Over – Take Over Form

Hand Over By (Production In-charge) Take Over By (Store In-Charge)

Name of Product: Khadiradi vati

Batch Size: 10 g Batch No: S003

Mfg. Date: March 2022 Exp. Date: 3 years from the date of manufacturing
MRP. Rs.:

No of Carton Hand Over: No of Pcs. Take Over:

……. gm ………………………… Carton Loose …………………………. Pcs

……. gm ………………………… Carton Loose …………………………. Pcs

Total No of Carton:…………. Total No of Loose Pcs …………………….

Hand Over By Take Over By

(Name, Sign & Date) (Name, Sign & Date)