Hindustan Laboratories, Palghar

Bill of Raw Material

Page - 01 of 03 Status of BOM FINAL
Dosage Form : Tablet BOM No BOM/TEI/F/01 BOM Date 19.05.2020 Revision No 1

VITAMIN C WITH ZINC CHEWABLE

Brand Name VITCEE - Z Generic Name
TABLETS
Each uncoated Chewable tablet contains
Ascorbic acid IP 100 mg
Sodium Ascorbate IP 450 mg
Label Claim as per Equivalent to Ascorbic acid 400 mg
Shelf life 24 Months
FDA Approval Zinc Sulphate Monohydrate IP
Equivalent to Elemental Zinc 20 mg.
Colour - Sunset Yellow FCF
Excipients Q.S.

Mfg Lic. No. KD - 311 Product Approval Date 09.05.2020 Excise Status CENTRAL

Packing 15's Quantity of Sales pack 6666 x 15's

129.000 Kg =
Batch Size :
1,00,000 Tablets
Minimum 50.000 Kg. Maximum 1290.000 Kg.
Batch Size = 38,760 Tablets Batch Size = 10,00,000 Tablets

16 mm round with break line on upper side &

Core Weight of Tablet 1290 mg Coated Weight ----- Punch Size Shape Round
plain from lower side.

Existing Proposed
Label Claim Each % of Total Qty. Qty. per Tab
Sr. No Ingredients Qty. in % Remarks
Tablet OA with OA Qty for 1,00,000 Tablets (in mg)

Active Material

1 Ascorbic Acid IP Kg 100 mg 1 101 mg. --- 10.100 7.829 101.000

Sodium Ascorbate 450 mg 454.5 mg.

2 450 mg Equivalent to IP Kg Eq. 1 Eq. --- 45.450 35.233 454.500
400 mg of Ascorbic acid. 400 mg. 404 mg.

Zinc Sulphate
55 mg 56.1 mg.
Monohydrate 55 mg
3
Equivalent to Elemental
IP Kg Eq. 2 = --- 5.610 4.349 56.100
20 mg. 20.4 mg.
Zinc 20 mg. **

Excipients
Saccharin
4
(Insoluble Powder)
IP Kg --- --- --- --- 0.060 0.047 0.600

*2% Exta added for

Sucrose *
5
(Pharma Grade)
IP Kg --- --- --- --- 61.700 47.829 617.000 (Loss of Water
content)

6 Indion - 234 IP Kg --- --- --- --- 0.100 0.078 1.000

7 Sucralose IP Kg --- --- --- --- 1.500 1.163 15.000

8 Saccharin sodium IP Kg --- --- --- --- 0.190 0.147 1.900

9 Citric acid monohydrate IP Kg --- --- --- --- 1.000 0.775 10.000

10 Sodium Chloride IP Kg --- --- --- --- 0.200 0.155 2.000

11 Orange Flavour IHS. Kg --- --- --- --- 0.300 0.233 3.000

12 Flavour Vanilla IHS. Kg --- --- --- --- 0.300 0.233 3.000

13 Magnesium Stearate IP Kg --- --- --- --- 3.500 2.713 35.000

Colour Sunset Yellow

14
FCF
IHS. Kg --- --- --- --- 0.200 0.155 2.000

15 Purified Water (δ) IP Ltr. --- --- --- --- 1.550 1.202 15.500 δ Does not appeare
in final product

Therotical Quantity = 129.000 100.000 1290.000

Actual Qty (With Extra Sucrose Qty ) = 130.210 100.938 1302.100

δ - Does not appeare in final product

Checked / Verified by Approved By Authorized By

Prepared By
Production HOD QA - Manager DGM Production Head QA Head Plant

Director
S.S. Patil R.P.Yadav K. S. Bhonde A.P. Patil D.H. Giri B. K. Shukla
 Hindustan Laboratories, Palghar
Bill of Packing Material
Page No. : 02 of 03
Status of BOP FINAL
BOM No BOM/TEI/F/01 BOP Date 19.05.2020
Revision No 1 Revision Date ---
Dosage Form : Tablet
Brand Name VITCEE - Z
Generic Name
VITAMIN C WITH ZINC CHEWABLE TABLETS

Each uncoated Chewable tablet contains

Ascorbic acid IP 100 mg
Sodium Ascorbate IP 450 mg
Label Claim as per Equivalent to Ascorbic acid 400 mg
FDA Approval Zinc Sulphate Monohydrate IP
Equivalent to Elemental Zinc 20 mg.
Colour - Sunset Yellow FCF
Excipients Q.S.

Packing Specification Aluminium Plain & Ptd Foil, Carton, shipper, BOPP Tape & Nylon Straps etc

B. Size 129.000 Kg = Quantity of

Packing 15's 6666.666 x 15's
in Kg/ Nos : 1,00,000 Tablets Sales pack

Existing Proposed
Sr. No Packing Material Unit Remarks
Qty. for 1,00,000 Tablets

ALU - ALU Strip Pack Size : {15 x (40x15's) }

Aluminium foil Plain
1
167 x 0.04 mm
Kg --- 17.800
Aluminium foil Printed Tab.
2
167 x 0.04 mm
Kg --- 17.800

3 Carton - 40 x 15’s Nos --- 170

Shipper 5 ply
4
{15 x (40 x 15's)}
Nos --- 11.111

BOPP Transparent 'HL' printed

5
tape 48 mm
Roll --- 0.556

6 Nylon Straps Mts --- 38.889

Authorized
Prepared Checked / Verified by Approved By
By
By
Production QA -
HOD DGM Production Head QA Head Plant
Manager

K. S.
Director
S.S. Patil R.M.Yadav A. P. Patil D. H. Giri B. K. Shukla
Bhonde
 Hindustan Laboratories, Palghar
Revision card

Name of Product : VITAMIN C WITH ZINC CHEWABLE TABLETS

BOM No. BOM/TEI/F/01 Page No. 03 of 03
( VITCEE - Z )

Date of revision Revision No. Revision Details Reason for Revision

As per Marketing
19.05.2020 1 New BOM prepared.
Requirement

Prepared By Checked / Verified by Approved By Authorized By

Production HOD QA - Manager DGM Production Head QA Head Plant

Director
S.S. Patil R.P. Yadav K. S. Bhonde A. P. Patil D. H. Giri B. K. Shukla
1 Ascorbic Acid IP Kg 51.000 51.000 ---

2 Pregelatine Starch IP Kg 8.700 8.700 ---

3 Tartaric Acid IP Kg 0.300 0.300 ---

4 Purified Water IP (δ) Lt. 12.410 3.030 DECREASED
5 Methyl Paraben IP Kg 0.050 0.050 ---
6 Propyl Paraben IP Kg 0.005 0.005 ---
7 Maize Starch IP (Dried) Kg 0.945 0.945 ---
8 Purified Talc IP Kg 0.500 0.500
9 MCC IP (Sancel 102) Kg 1.000 1.000
10 Colloidal Silicon Dioxide Kg 0.500 0.500
IP(Aerosil – 200)
11 Magnesium Stearate IP Kg 1.000 1.000

Total RMValue
% of Changes in value
Costing per pack-- of 10 tabs

Justification for Revision Remarks : No change in BOM

HOD Production manager QA - Manager Manager Plant Qa- Sr manager Sr General Manager

Prepared By-- Checked by Checked by Verified by Approved By Approved By

 Pkg. Material
Printed Alum. Foil 180mm
1
(0.03mm)
kg 10.750

Printed Alum. Foil 180mm

2
(0.03mm)
kg 10.750

3 Printed Show Box-50 x10’s nos 200

4 5 Ply Box – 40x (50x10’s) nos 5
5 48 mm HL Ptd. BOPP tape Roll 0.25
6 Plain Nylon Straps Mts 20

Total PMValue

Justification for Revision Remarks : NO Change in BOM.

HOD Production manager QA - Manager Manager Plant Qa- Sr manager Sr General Manager

Prepared By-- Checked by Checked by Verified by Approved By Approved By