PRODUCT NAME :
LIC. NO. :
PRODUCT CODE :
M.F.R. NO. :
EFFECTIVE DATE :
REVIEW DATE :
SUPERSEDES :
REVISION NO . :
INDEX
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
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.
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.
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.
The procedure whereby the oldest approved stock of the material is distributed first is followed.
SPECIMEN LABELS
It includes product name, batch number, manufacturing date, expiry date, manufacturing site address,
net weight, gross weight, storage conditions & special precautions.
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
REACTOR
REFLUX
FILTER
REACTOR + Cooling
CENTRIFUSE
DRYING
MILLING
SHIFTING
PACKING
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. 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.
- 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
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.
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.