PHARMCHEM

Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

Format Number: QA/011/F1-00 Effective Date: Page No.:1 of 13

MASTER FORMULA RECOED

PRODUCT NAME :

LIC. NO. :

PRODUCT CODE :

M.F.R. NO. :

EFFECTIVE DATE :

REVIEW DATE :

SUPERSEDES :

REVISION NO . :

INDEX

SR. PARTICULARS PAGE NO.

NO.

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NAME
DESIGNATION
DEPARTMENT
SIGN./DATE
Format No.: QA/001/F2-00
 PHARMCHEM
Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

Format Number: QA/011/F1-00 Effective Date: Page No.:2 of 13

1 Introduction
2 Manufacturing Plant
2.1 Warehouse
2.2 Manufacturing Facility
2.3 Raw material handling
3 Manufacturing Process
3.1 Process Flowchart
3.2 List of Equipments
4 BPR
5 Quality Control System
6 Stability Study
7 Utility
8 Effluent Treatment Plant

NICOTINAMIDE
1. INTRODUCTION

Product : Nicotinamide
Physical Characteristics : A white, crystalline powder or colourless
crystals.
Solubility : Freely soluble in water and in ethanol.
Molecular Weight : 122.1

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 PHARMCHEM
Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

Format Number: QA/011/F1-00 Effective Date: Page No.:3 of 13

Molecular Formula : C6H6N2O

Molecular Structure :

CAS No : 98-92-0
Action & Use : Component of vitamin B.
Master Batch Size : 200kg

2. MANUFACTURING FACILITIES
The facilities available at plant are as following
2.1 Ware- house
2.2 Manufacturing plant
2.3 Raw material handling
2.1 Warehouse
Ware house facility consists of the following:
a. Solid raw material storage area: All solid raw materials used are stored in separate raw
material store building.

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Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

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b. Solvent storage area: All liquid solvents, which are stored into drums in separate solvent
storage area.
c. Packaging material storage area: packaging materials like fiber/HDPE drums/polythene
bags are stored in separate area of solid raw material storage building.
d. Dispensing area: This area is used for dispensing of solid raw materials. It is equipped
with weighing balance.
e. Engineering goods area: All engineering goods used are stored in separate engineering
goods area.
2.2 Manufacturing Plant
The production facility is divided in two main areas:
1.Chemical processing area
2.Powder processing area
Chemical processing area: All reactors, centrifuges and filters are located in this area plant no.2.
Powder processing area: This area is further divided into following separate areas
 Dryer Room
 Multimilling, pulverizing
 Quarantine rooms, Finish Goods.
This area is also provides with Temp. & Humidity control.
Equipment maintenance & calibration: The manufacturing facilities are maintained by a
program of preventive and shut down maintenance procedures. Periodical maintenance of
equipment is done by the In –House maintenance department.
Calibration: Calibration of some measuring devices installed in bulk drug facility is performed by
outside.

2.3 Raw Material Handling

Incoming Procedure

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Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

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Delivery of RM is taken by store in-charge who will check the challan, invoices.
Each consignment of material is sequentially entered in to a register.
The consignment received is checked for the number of containers damages labels batch no.
quantity manufacture/ supplier etc.
Batch Numbering System
Every consignment of RM received is segregated batch wise or lot wise. A goods receipt report is
prepared based on this number. This report will indicate all receipt details of RM.
Raw Material Sampling & Release
A good receipt report is prepared by store department and sent to quality control.
Material in quarantine is identified by under test label pasted on drums showing quarantined
status.As the status of material changes i,e. when the material is sampled by a sampled stamp.
Representative sample of each batch no./ lot is collected as per sample plan by formula √n+1.

Raw Material Release

After analysis results are entered in the protocol and QC reference no. are given in the numbering
register. A approved or rejected slips are prepared accordingly.
The original copy of report is retained for QC records. Copies of analytical reports are forwarded
to production and store department.
The sampling chemist will go to stores and change the status position of raw material by affixing
“APPROVED” or “REJECTED” stickers.
The stores personnel then enters of the raw material in their stock register .

Raw Materials Distribution

Stores department maintains the physical stock of the approved raw materials.
The material is issued against the issue indent received form plant.
The materials are issued batch/ lot wise. Quantities of each raw material required for each batch/
lot are checked as per the standard norms.
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Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

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The procedure whereby the oldest approved stock of the material is distributed first is followed.

Packing Material Specification

1. Common Name : Drum
2. Specific Name : Fiber drum for 25 Kg
3. Description : Brown colored, plain, Cylindrical Drum,
closed at one end and covered with a
detachable lid on other end.
4. Size : Tolerance
a. Height : 508.00 mm (508 mm to 510 mm)
b. Diameter : 406.00 mm (406 mm to 408 mm)
5. Weight with Cover : 4.25 Kg (+ 5.00 %)
6. Thickness of the wall : 3.8 mm (3.6 to 4.0)

SPECIMEN LABELS
It includes product name, batch number, manufacturing date, expiry date, manufacturing site address,
net weight, gross weight, storage conditions & special precautions.

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 PHARMCHEM
Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

Format Number: QA/011/F1-00 Effective Date: Page No.:7 of 13

MANUFACTURING PROCESS
4.1. List of Raw Materials Required
S. No. Name of the Raw Materials Quantity Required
1 3-Cyano Pyridine 600 Kg
2 Purified Water 425ltr
3 Sodium Hydroxide 8.4 Kg
4 Activated Carbon 1.5Kg
5 Liquor Ammonia 2.0 ltr

Standard Batch Size 200kg

The following steps are followed in manufacturing of NICOTINAMIDE:-
Charge purified water in appropriate capacity reactor.
Charge 3-cynopyridine in reactor and maintain the required temperature.
After obtaining the required temperature add the sodium hydroxide solution for hydrolysis.
Maintain the reflex for defined period.
Add activated Charcoal.
Hydrolyzed mass is filtered through the suitable filter.
Hydrolyzed mass is basified with ammonia solution.
Basified material is centrifuged.
Centrifuged material is dried in a drier.
The dried material is grinded through multimill through appropriate mess.

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Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

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3.2 MANUFACTURING FLOW CHART :

PURIFIED WATER 3 CYANOPYRIDINE

SODIUM HYDROXIDE SOLUTION
ACTIVATED
CARBON

REACTOR

REFLUX

FILTER

REACTOR + Cooling

CENTRIFUSE

DRYING

MILLING

SHIFTING

PACKING

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 PHARMCHEM
Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

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3.2 Major Production Equipments Required For Nicotinamide

S. No. Equipments Capacity Number

1 R-109, SS reactor, jacketed with agitator 2000L 1
2 R-109, SS-316 with agitator, 5HP flame proof motor & 2000L 1
gear box with variable speed
3 Multi mill 100kg/h 1
4 Pulverizer SS-316 50kg/h 1
5 Shifter SS-316 100kg/h 1

3. QUALITY CONTROL LABORATORY

Quality control laboratory worked independently and having all the testing facilities in the premises with SOP’s,
STP’s etc. We are having “Reference Standards” of all the products.

 Wet Chemical laboratory, there is a well-equipped instrumental testing laboratory having KF titrator,
Polarimeter, pH meter, electronic weighing balance.
 Instrument lab includes computerized analytical instruments such as High performance liquid
chromatograph, Gas Chromatographs etc.
 Microbiological testing laboratory include state of art facilities involving AHU controlled room and
laminar bench to name a few. .

4.1 List of Laboratory Equipment

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 PHARMCHEM
Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

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S. No. Name of Instrument Make Quantity

1. HPLC ( LC-10A VP) Shimadzu One
3. Gas Chromatography System (NUCON-5700) One
4. UV Spectrophotometer Beckman Model DU 40 One
5. Polarimeter Advance One
6. K.F. Titrator (Veego/MATIC–D) One
7. Auto K. F. Titrimeter N.S One
8. Electronic Balance Dhona (200-D) One
9. Electronic Balance Denver (APX-60) One
10. Melting Point Apparatus (APX-60) One
11. Digital pH Meter (Toshiba) NIG 333 One
12. Digital pH Meter (Toshiba) 152R One
13. Humidity Cabinet (Toshiba & Multitech) Two
14. Muffle Furnace N.S One
15 Hot Air Oven Ambassador One
16. TLC UV Cabinet Toshiba India (Delhi) One
17. Ultra sonicator bath 105 (H) One
18. Vacuum pump N.S One
19. Magnetic Stirrer with hot plate Toshiba India Ltd. One
20. Potentiometer Metrohm One
21. Heating mental 100watt Sunbeam India Ltd. Four
22. Vacuum pump PpI Pump One
23. Distillation apparatus Remimoters Two

4. STABILITY STUDIES
A documented ongoing testing program is designed to monitor the stability characteristics of the product
and the result is used to confirm appropriate storage condition and retest or expiry dates. The stability
testing is carried out using the following protocol.
Procedure
Selection batches and sample size:
- Three consecutive commercial production batches will be used for long term and accelerated
stability testing.One batch after every six months will be kept for the above testing.

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Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

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- 25 gm of the sample from each batch will be used for stability under the stability storage conditions.
Specification and Procedure
- Sample will be analyzed for the following test as per standard testing procedure.
- Description
- MeltingPoint
- pH
- LOD
- Sulphated Ash
- Assay
Storage Conditions
- Sample will be placed under the following conditions.
Testing Temp./ Humidity Period
Long term testing Temp. 250C ± 20C Up to expiry
RH 60% ± 5%
Accelerated Temp. 400C ± 20C 6 Months
RH 75% ± 5%
Packing
- Sample will be packed in double polybags with inner and outer packing of transparent polybags that
simulate the market containers.
Testing frequency
- The sample kept for long term testing are analyzed after zero, three, six, nine, twelve, eighteen,
twenty four, thirty six or up to expiry.
- The sample kept for accelerated study is analyzed after every month up to 6 months.

7. UTILITIES

Utility system support the manufacturing operation centralized utilities include:

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Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

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 Power receiving and distribution system.

 Standing power generation station.
 Motor treatment, storage and distribution system
 Steam generation and distribution system.
 Low temperature chilled brine system.
 Compressed air system.
 All utilities systems are operated and maintained as per the best engineering practices.

S. No Equipments Capacity
1 Generator (kirloskar cumins0 125 kva
2 Generator (kirloskar) 62.5 kva
3 Generator (kirloskar) 33 kva
4 Chilling plant with kirloskar Cumins compressor 25 ts 25 ts.
refrigeration cap. of brine -30 C
5 Chilling plant excel - 5 chilled water brine 10 Ts.
6 Boiler automatic oil fired makes energy machines, (hp 400 kg. /hr.
steam/lp steam both).
7 Water Softening Plant 1 each/gener.
8 Purified Water Plant 80 kl/gener.
9 SS Centrifugal Pump 3 kl/hr
10 MS Butterfly Pump 2kl/hr
11 Distillation unit with 1000 l distillation vessel with 24 feet 130l/hr
column. & SS 304 condenser of 5 sq. Meter.

8. EFFLUENTS TREATMENT PLANT

The gaseous effluents are scrubbed or condensed, eliminating any emissions.

Waste water generation is minimized by recovery and recycle as far as is practical liquid effluents is treated
chemically, followed by aerobic digesters in an effluent Treatment plant. The treated water is used for in
house land irrigation.

Solid waste is packed in poly bags & dump into the space provided by Municipal Corporation.

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Modern Industrial Estate, Bahadurgarh,- 124507 Haryana

Title: Master Formula Record

Format Number: QA/011/F1-00 Effective Date: Page No.:13 of 13

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