Shri Ram Murti Smarak College of Engg. & Technology, Bareilly, U.P

Practice School Report TOPIC:- BMR
SHRI RAM MURTI SMARAK COLLEGE OF

ENGG. & TECHNOLOGY, BAREILLY ,U.P.
Practice School Report

Topic:- Batch Manufacturing Record (BMR)
UNDER GUIDANCE OF: - SUBBMITED BY:-

Md. Semimul Akhtar Chandresh Patel
Associate Professor 1701450018
SRMS CET (Pharmacy), B. Pharm. (7th Sem)
Bareilly, U.P.
SRMS CET (PHARMACY), Bareilly, U.P. 1

ACKNOWLEDGEMENT
I would like to express my heartiest gratitude and thanks to my guide Md.
Semimul Akhtar, Associate Professor, SRMS CET, Bareilly, U.P. for his
guidance and keen interest shown towards my work. I am cordially thankful for his
efforts in helping me to complete this Practice School report on Batch
Manufacturing Record successfully. Under his guidance I came to know about
various aspects of pharmaceutical industry (specially in tablet manufacturing) and
several regulatory aspects related to it.
I would also like to express my sincere thanks to Dr. Lalit Singh, Director
Pharmacy, SRMS CET, Bareilly, U.P. for his invaluable and unconditional
support to me regarding this Report.
I would also like to thanks my teachers and colleagues for their inspiration,
support and valuable suggestions throughout the course of my work and beyond
that. Words fall insufficient to express the feeling towards my family whose words
were always encouraging and supporting me and without which I could not be
successful in all my endeavors.
Yours sincerely,
Chandresh Patel
B. Pharm ( 7th sem )
1701450018

Content
1. Introduction………………………………………………………...3
2. Preparation of tablet……………………………………………….4-19
 Dispensing…………………………………………………….….4-8
 Purpose, Objective, Scope, Responsibility………..…….4
 Procedure………………………………………….…..…..4-6
 Types of balances used for dispensing………….…….…7-8
 Sizing………………………………………………….…………..8-11
 Size reduction equipments…………………………….….9-11
 Blending…………………………………………………….…….11
 Pneumatic mixers………………………………….……...11
 Diffusion mixers………………………………….……….11
 Convective mixers…………………………….…………..11
 Granulation………………………………………….…………...12-14
 Dry granulation…………………………………………...12
 Wet granulation…………………………………………...12-13
 Differences between wet and dry granulation………..…13-14
 Equipments used for granulation……………………...…14
 Drying…………………………………………………………..…15-17
 Equipments used for drying……………………………….15-17
 Tablet compression…………………………………………….…17-18
 Equipment for tablet compression………………………..18
 Packaging………………………………………………………….19
 Types of packaging for tablets………………………….....19
3. BMR (Sample)…………………………………………………………20-25
4. Conclusion……………………………………………………………..26
5. References……………………………………………………………...27-29

Introduction
A batch manufacturing record is a document designed to provide a complete record of the
manufacturing history of a batch of product. [1] Batch Manufacturing Record is a written
document that is prepared during the pharmaceutical manufacturing process. It contains actual
data of the batch manufacturing and whole manufacturing process step by step. There are several
stages of pharmaceutical product manufacturing process. All stages are included in the batch
manufacturing record from the issuance of the raw material to the final packaging.[2]
The US Food and Drug administration defines a batch as “a specific quantity of a drug or
other material that is intended to have uniform character and quality, within specified limits, and
is produced according to a single manufacturing order during the same cycle of manufacture”.[1]
Batch Manufacturing Records are critical documents for ensuring quality and regulatory
requirements are achieved.[1] They normally contain information that relates to the following
aspects of the manufacture of a batch of product:
 Dates of start and finish of manufacture.

 Lists all materials used and amounts of each used.
 Lists of packaging materials used.
 Details of the steps completed in the manufacturing process and times of completion.
 Initials of the person responsible at every stage.
 Details and results of all in-process checks.
 Reference to any equipment used.
 Batch yield and reconciliation.
 Any deviations.
 Quality Control information.
In many cases the Batch Manufacturing Records are written in an instructional format with areas
for the operator to enter processing information. It is very important to provide the information in
the Batch Manufacturing Records where requested. For certain critical operations, e.g. weighing
of raw materials, a second person must check calculations and identity of materials and sign off
on the Batch Manufacturing Records. Each batch has an individual number, written on the Batch
Manufacturing Record.[1]
Batch Manufacturing Records must be:

 Legible.
 Permanent.
 Accurate.
 Original.
 Signed.
Every batch has a separate BMR having batch history of batch production. Documents and
proofs are attached to the BMR during the manufacturing process. All corrections and deviations
must be recorded and signed off in the Batch Manufacturing Records.[1]

Preparation of Tablet
Tablet is defined as solid pharmaceutical dosage form containing drug substance generally with
suitable diluents and prepared by either compression or molding methods. Because of their
composition, method of manufacture or intended use, tablets present a variety of characteristics
and consequently there are several categories of tablets. Tablet formulation and design may be
described as the process where by the formulator ensures that the correct amount of the drug in
the right form is delivered at or over the proper time at the proper rate and in the desired location,
while having its chemical integrity protected to that point.[3]
Steps involved:-
1. Dispensing of raw materials:-

Purpose: To define the procedure for dispensing of raw materials.[4]
Objective: To provide guidelines for dispensing of raw materials.[4]
Scope: This procedure applies to dispensing of raw materials in stores department.[4]
Responsibility:-
Follow up:- Officer – Stores[4]
Overall responsibility:- Store In-charge.[4]
Procedure:-
Stores Officer:- Receive the raw material issue requisition and record the serial number,
material code and date of receipt. Check for the entries in all the columns viz. Dept, Batch Size.,
Batch No. and signatures for requisite by and authorizes by. If any of these columns is missing,
return the requisition to production.[4]
From the raw material stock register, check the quantities of material available and quantities
requested for. If any of the material in stock is less than the requisitioned Quantity, inform to
Stores In-charge.[4]
Stores In-charge:- Check the materials in “Under Test” status. If the material requisitioned is
present in “Under Test” status, inform the Manager – Production and Asst. Manager – QC
regarding the same. Hold the issue of the other materials till the material is approved by QC.[4]
Stores Assistant:- Check the dispensing area for the following Cleanliness.[4]
 No other material is present in the area

 The balance is clean and has been calibrated for the day.
 Availability of cleaned dispensing devices (scoops, etc.)

 Protective equipment has been worn as per the material safety data sheet.
 Check the details of the material on the Approved Label.
o Name of the Material o Tare Wt

o Batch No. o Gross Wt.
o Batch size. o Net Wt.
o A.R. No. o Date.
o Quantity. o Signature
o No. of container.
 Check the tare weight of the empty container and note down on the dispensed label.
 Select the bulk raw material container of appropriate AR No as per FIFO system. Check
the retest date on the label. If the retest date falls in the month of issue, inform QC
regarding the retesting.
 Transfer the material to the dispensing area. Carefully transfer the material into the
container till the quantity required is transferred
 Note down the final weight of the container and record on the dispensing label for gross
weight.
 Calculate the net weight and record on dispensing label and sign for issued by.
 Close the bulk raw material container and transfer back the bulk raw material container to
the original space.
 Repeat the steps for remaining materials of the raw l issue requisition one after the other.
 Never keep more than one material in the dispensing area. Transfer the second material
only after the first has been dispensed and transferred back to its original space.
 Always use clean dispensing devices and do not contaminate one with other material.
 Enter the details of issue into the raw material stock register for the material.
 Verify the quantities dispensed against the raw material issue requisition and sign for
Store officer.
 Inform the Asst. Manager – Production / Manager – Production regarding the checking of
the material.
Material requisition will be made two copies. One copy will be kept in store department and
duplicate copy attach with B.M.R.
Reference documents[4]:-
 Material Requisition Note.
 Dispensing activities log book

 Stock Register in Raw Material.
MATERIAL REQUISITION NOTE Sr. No.

To: Store Department From Production Department
Kindly issue the following Raw Material as per details given below.
Name of Product: ____________________________________ Stage No.: ______________
Batch No.: ________________ Batch Size: ________________Kg Mfg. Date: _____________
Sr. No. Material Name Material Quantity in Kg/L Batch No. A. R. No/Store Ledger
code Required Issued Folio
Format No.F/ST/009
Material Requisition:
Issued By (Production) Authorized By (Production) Received By (Stores)
Sign & Date Sign & Date Sign & Date
Dispensed Material
Dispensed By (Stores) Checked By (Stores) Received By (Production)
Sign & Date Sign & Date Sign & Date
Date. Activities TIME Product Product B.No Batch Dispensed Checked Remark
From To Name Code /stage Size by By
Ss
Stage
[4]

Types of balance
The pharmaceutical industry use a wide range of weighing instruments. These can be categorised
as[5]:
 Load cells
 Platform scales
 Precision balances
 Analytical balances
 Semi-micro balances
 Micro balances.
All of these categories other than the load cells will normally use an Electro motive force
weighing cell.
Load cells:- Load cells generally consist of a spring element on which strain gauges have been
placed. The spring element is usually made of steel or aluminum. That means it is very sturdy,
but also minimally elastic. As the name "spring element" suggests, the steel is slightly deformed
under load, but then returns to its starting position, responding elastically to every load. These
extremely small changes can be acquired with strain gauges. Then finally the deformation of the
strain gauge is interpreted by analysis electronics to determine the weight.[6]
A load cell will have a capacity of 10 kg to several tonnes and will normally have
a resolution of 0.1 kg or greater. In manufacturing operations production vessels may be
mounted on load cells to control the quantity of materials added during the creation of a
batch.[5]
Platform scales:- An industrial weighing instrument consisting of a platform coupled to an
automatic system of levers and adjustable weights, used to weigh large or heavy objects.[7]
Platform scales could have a capacity of up to 1 000 kg or more, and will have a
resolution of 0.1 g or greater. These are widely used in the pharmaceutical industry to
measure the quantity of material to be added to a batch or to weigh the quantity of
product manufactured. Some platform scales will be operated with software functions,
e.g. piece counting, where the weight of product can be displayed as the number of units,
e.g. tablets produced.[5]
Precision balances:- In the weighing industry, we define precision balances as “a balance used
to weigh quantities to a very precise number, usually up to one milligram”. They’re sometimes
referred to as “top loading balances”. Precision balances are available in a wide range of
capacities, from several hundred grams up to kilograms. They’re not as precise as analytical
balances, but more precise than the average bench or compact scale. Also, precision balances
have a higher capacity than analytical balances, but a lower readability.[8]
Precision, or top pan, balances will have a capacity up to 20 kg and a resolution of
0.001 g or greater. They are very widely used in the pharmaceutical industry throughout
laboratory and production operations. They will be used in the laboratory for general
weighing operations, e.g. to weigh materials during the preparation of reagents. In
production areas they can be used to weigh small quantities of material for addition to a
batch or for checkweighing operations as part of the quality control of the process.[5]
Analytical balances:- Analytical balances are highly sensitive lab instruments designed to
accurately measure mass. Their readability has a range between 0.1mg - 0.01mg. Analytical
balances have a draft shield or weighing chamber to prevent the very small samples from being

affected by air currents. They're meant to detect very fine increments, so the slightest vibrations
or breeze can impact the results. As such, analytical balances should be used in a dedicated room
with as few disturbances as possible. Analytical balances need to be monitored carefully and
calibrated frequently. Most analytical balances have both automatic internal motorized
calibration and calibration with external weights.[9]
Analytical balances will have a capacity up to 500 g and a resolution of 0.1 mg or
0.01 mg. These balances will have an enclosed draft shield to create a weighing chamber.
Analytical balances are used mainly in laboratory areas for the weighing of samples
during the performance of an assay although they may also be used as an alternative to a
precision balance in production areas where small quantities are to be weighed.[5]
Semi-micro balances:- Semi-Micro balances feature one hundredth of a milligram precision for
laboratory weighing applications. If you need a lab balance reading to 5 decimal places that is
more precise than an analytical balance (4 decimal places), consider one of the semi-micro
balances.[10]
Semi-micro balances will have a capacity up to 30 g and a resolution of 0.001 mg
or 0.002 mg. These balances will normally be an extension of a manufacturer’s range of
analytical balances and will be used for laboratory weighing where a more accurate
weighing is required than is possible on the analytical balance but where a full
microbalance is not justified.[5]
Microbalances:- Micro Balance is designed to meet the highest requirements for determination
of mass. Measurement reliability and accuracy are maintained by system of automatic internal
adjustment calibration. Micro balances comprise two major components (an electronic module
and a precise mechanical measuring system are enclosed separately). The design eliminates the
influence of heat sourcing from instrument’s electronics on its mechanical components and
additionally protects it from shocks and vibrations caused by users operating the instrument. All
the elements of a microbalance are made of glass and steel which eliminates the influence of
electrostatics on weighing process.[11]
Microbalances will normally have a capacity of less than 1 g and a resolution of at

least 0.000 1 mg. They will be used in laboratory areas where very accurate weighing is
required.[5]
Before any balance is used for a manufacturing or testing stage the balance must be validated.[5]
2. Sizing:- The particle size distribution of active ingredients and excipients is an important
physical characteristic of the materials used to create pharmaceutical products. The size,
distribution and shape of the particles can affect bulk properties, product performance,
process ability, stability and appearance of the end product.[12]
The link between particle size and product performance is well documented with regards to
dissolution, absorption rates and content uniformity. Proper matching of active ingredient and
excipient particle size is important for several process steps. Particle size analysis is an integral
component of the effort to formulate and manufacture many pharmaceutical dosage forms.[12]
It is important to describe the effectiveness of physical end chemical processes and the quality of
semi-finished products and final products. Modern techniques cover a size range from
nanometers up to millimeters.[13]

 Laser Diffraction or static light scattering for particle size analyses of dry powders or
powders suspended in aqueous or organic liquids
 Droplet size distributions of sprays, nebulizers, inhalers, etc.
 Image Analysis – “Seeing is Believing”.
 Nanoparticle assessment by photon correlation spectroscopy
 Zeta potential
 Gravitational Sedimentation
 Electrical Sensing Zone, highest resolution for narrow size distributions – applicable for
cleanliness investigations of liquids and particle concentrations of dispersions.
 Sieve Analysis, mechanical, dry, wet, and sonic.
 Morphology (surface and size) by scanning electron microscopy (SEM) coupled to
elemental analysis with Energy dispersive X-ray (EDX)
Size reduction equipment/ communition equipment:- Various equipments used for size
reduction are hammer mill, vibration mill, roller mill, pin mill, fluidized energy mill, end-runner
mill, edge-runner mill, cutter mill and ball mill etc.[7]
a) Hammer mill:- Hammer mill is the most widely used grinding mill and among the oldest.
Hammer mills consist of a series of hammers (usually four or more) hinged on a central shaft
and enclosed within a rigid metal case. It produces size reduction by impact.[14]
The materials to be milled are struck by these rectangular pieces of hardened steel (ganged
hammer) which rotates at high speed inside the chamber. These radically swinging hammers
(from the rotating central shaft) move at a high angular velocity causing brittle fracture of the
feed material.[14]
b) Vibration mill:- A vibration mill is a size reduction equipment that applies the process of
continuous impaction in carrying out its size reduction function. The grinding container is
made up of a tube that is held in a frame that is supported by means of springs which is filled
to approximately 80% total volume with porcelain or stainless steel balls.[15]
During milling, the entire body of the mill undergoes a small but frequent
vibration that is generated by an eccentric motor, and size reduction occurs by repeated
impact. This vibration is usually, but not necessarily, in a vertical plane. Vibration mills
are similar to ball mills in that particles of the materials are crushed between porcelain or
metal balls and the mill body.[15]
c) Roller mill:- Roller mill is a form of compression mill that uses a single, double, or triple
cylindrical heavy wheel mounted horizontally and rotated about their long axis either in
opposing pairs or against flat plates, to crush or grind various materials. One of the rollers is
run by a motor and the others are rotated by friction as the material is drawn through the gap
between the rollers.[16]
Roller mills use the process of stress (which is applied by the rotating wheels) and attrition in
milling of solids in suspensions, pastes or ointments, and some solid materials. The rollers rotate
at different speeds and the material is sheared as it passes through the gap.[16]
d) Pin Mill:- The pin mill also categorized as a disc mill is a kind of milling equipment that can
break up cellular materials selectively without damaging the starch granules. It consists of

two horizontal steel plates with vertical projections arranged in concentric circles on
opposing faces and becomes more closely spaced towards the periphery.[17]
Pin mill uses a series of pin breakers attached to discs instead of hammer in the rotating grinding
head to achieve high energy impact between the mill and the particles. It is traditionally
employed to disintegrate starch- protein bond that exist in the material and produce fine flour.[17]
e) Fluidized Energy mill:- Fluidized Energy mill, also known as micronizer or jet mill is a type
of mill that consists of a hollow toroid that has a diameter of 20-200 mm depending on the
height of the loop which can be up to 2 m. It operates by particle impaction and attrition.[18]
A fluid or milling gas, usually air or inert gas is injected as a high-pressure jet through nozzles at
the bottom of the loop. The powder particles in the mill are accelerated to high velocity.[18]
f) End runner mill:- The end-runner mill consists of a weighted pestle mounted eccentrically
in a ceramic, granite or metal mortar, which is rotated by a motor. The pestle rotates by
friction and is free to rise and fall in the mortar so that its grinding action involves both
impact and shear, the material being crushed and rubbed between it and the rotating mortar.
[19]
Spring-loaded scrapers ensure that material is constantly returned to the grinding area and at the
end of the operation the pestle can be swung clear of the mortar to facilitate emptying and
cleaning.[19]
g) Edge runner mill:- Edge runner mill, also known as Chilean mill or Roller stone mill
consists of one or two heavy steel or granite rollers mounted on a horizontal shaft and turned
round a central vertical shaft on a bed of steel or granite. The stones may vary from 0.5 to 2.5
m in diameter, the larger size weighing up to about 6 tones.[19]
The material to be ground is kept in the path of the runner by scrapers. The reduction is partly
due to crushing: by the weight of the stones, but more to friction between the surfaces of contact
between the runners and the bed stone.[19]
h) Cutter mill:- Cutter mill is a size reduction equipment consisting of a series of uniformly
spaced knives (2 to 12 in number) attached to a horizontal rotor (rotating knives) which act
against a series of stationary knives attached to the mill casing. The bottom of the mill has a
screen attached to control the residence time of the particles inside the mill head.[20]
Size reduction process involves successive mechanical sheering of the feed material with the
help of sharp knife.[20]
i) Ball mill:- A ball mill also known as pebble mill or tumbling mill is a milling machine that
consists of a hallow cylinder containing balls; mounted on a metallic frame such that it can
be rotated along its longitudinal axis. The balls which could be of different diameter occupy
30 – 50 % of the mill volume and its size depends on the feed and mill size. The large balls
tend to break down the coarse feed materials and the smaller balls help to form fine product
by reducing void spaces between the balls. Ball mills grind material by impact and attrition.
[21]
3. Blending:- Many industries rely heavily on mixing and blending technology to create
products. Within some of those products, blending various particulate ingredients is easy. In
other industries, such as pharmaceuticals, it’s not always so simple. Typically in the
pharmaceutical industry, small amounts of an active drug are exactly blended
with excipients, the non-active ingredients, such as cellulose, lactose, starch, or lubricants.
Excipients that are stickier than the active ingredient are harder to effectively blend, and a
significant difference in their sizes can cause segregation of the ingredients.[22]
Various equipments used in blending of pharmaceuticals are:-

a) Pneumatic mixers:- Pneumatic mixers sometimes called air-mix mixers or air-driven mixers
are mixers that use compressed air or air bubbles instead of electricity to mix or homogenize
materials or powders. The blender consists of a mixing silo and in some cases a central
conveying tube with an inverted conical deflector at the top for spreading material.[23]
b) Diffusion mixers:- Diffusion mixers, also known as tumbling mixers/blender is a
powder/solid mixing equipment that consists of a closed metallic vessel (usually stainless
steel) that rotates about an axis either manually or with the help of a motor at an optimum
speed. Powder particles, unlike fluids, must first be set in motion by some external action to
achieve a proper mix.[24]
c) Convective mixers:- Convective mixers consist of a vertical or horizontal static shell or
container (cylindrical, conical, U- or W- shaped trough) in which powders are circulated
around by a rotating blade, paddle or screw. The choice of mixer within the convective group
is much wider. Particles are reoriented in relation to one another as a result of mechanical
movement, also known as paddle mixing or plow mixing. Mixing consists of convection,
diffusive and shear mechanism.[25]
4. Granulation:- Granulation, a technique of particle enlargement by agglomeration, is one

of the most significant unit operations in the production of pharmaceutical dosage forms,
mostly tablets and capsules. During the granulation process, small fine or coarse particles are
converted into large agglomerates called granules. Generally, granulation commences after
initial dry mixing of the necessary powder ingredients along with the active pharmaceutical
ingredient (API), so that a uniform distribution of each ingredient throughout the powder
mixture is achieved. Although granules used in the pharmaceutical industry have particle size
in the range of 0.2-4.0 mm, they are primarily produced as an intermediary with a size range
of 0.2-0.5 mm to be either packed as a dosage form or be mixed with other excipients before
tablet compaction or capsule filling.[26]
Granulation process for tablet manufacturing process is of two types:-
 Dry Granulation
 Wet Granulation
a. Dry Granulation:- This requires two pieces of equipment, a machine for compressing the
dry powders into compacts or flakes, and a mill for breaking up these intermediate products
into granules. The dry method may be used for drugs that do not compress well after wet
granulation, or those which are sensitive to moisture.[27]
A summary of the various steps used in the manufacture of tablets by dry granulation method
can be summarized with the help of following diagram:-

[28]
b. Wet Granulation:- In this method, the wet mass is forced through a sieve to produce wet
granules which are then dried. A subsequent screening stage breaks agglomerates of
granules. Organic solvents are used when water-sensitive drugs are processed, as an
alternative to dry granulation, or when a rapid drying time is required. Because direct
compressing is not the best technology for many active substances, wet granulation is still a
preferred method. Even if the active substance is sensitive to hydrolysis, modern equipment
(e.g., a fluidized bed) eliminates all problems in wet granulation [27]

[29]
Differences between wet granulation and dry granulation methods[30]

 Typically, wet granulation processes require more equipment and plant space than dry
granulation technology.
 Wet granulation technology makes use of multiple and more expensive equipment
technology; thus has higher investment costs compared with dry granulation processes.
 Cleaning cycles are more frequent with wet granulation equipment trains than dry
granulation manufacturing equipment.
 Scale-up is less complicated with dry granulation compared with wet granulation.
o Wet granulation scale-up has many more major and minor variables to monitor during
wet granulation and drying processes than a dry granulation roller compaction process.
o Scale-up using wet granulation equipment requires larger bowl and batch sizes—
manufacturing capacity is a function of bowl size volume and manufacturing time.
o Scale-up using roller compaction can be accomplished with development sized
equipment—it only requires longer equipment operating hours as manufacturing capacity
is primarily a function of operating time providing more capacity and operational
flexibility.

 Wet granulation endpoints can change as the granulator power consumption profile can
change when manufacturing multiple consecutive batches during a shift or campaign-
requiring more sensor controls to understand the process.
 The wetting of raw material is more influenced by raw material property changes, for
example, particle size distribution, and density than raw material changes affecting roller
compaction.
 In the case of manufacturing a wet granulation batch, if an electrical outage occurs, the
probability of losing the batch is high if there is no backup battery system to quickly start up
and continue the process; this is not an issue with a roller compaction process.
 Massing effects and drying capacity issues are key concerns in scale-up for drying
granulations produced in separate steps for high- or low-shear wet granulation technologies.
Equipments used for Granulation
Some of the general categories of equipment used for granulating materials are listed below.[31]
 Rotary Drum Granulator  Pan Granulator

 Fluid Bed Granulators  Tablet Press
 Pin Mill Granulator  Pellet Mill
 Pug Mill Granulator  Briquetting Machines
 Rotary Drum Granulator:- The rolling drum granulator is one of the most widely used
granulating equipment devices, in which size enlargement is achieved by collisions in a bed
of moist particles undergoing rolling motion. The rolling drum is the simplest continuous
granulation device, and is widely used in the granulation of fertilizer and in the bailing of
iron ore. It consists of a rotating cylinder, which is slightly inclined to the horizontal to
facilitate the transportation of material through the drum. The drum is usually equipped with
a dam ring so as to minimize back-spill of the inlet material. At the outlet of the drum there is
often another dam ring, which allows an increase in depth of the bed inside the drum. Chutes,
pipes or conveyors may be used to transport the granulate at the inlet and outlet of the drum.
The solid material is normally wetted at or near the inlet of the drum, usually by spraying a
fluid/binder onto the bed of tumbling solids.[32]
 Fluid bed Granulator:- Fluidized bed granulator is one of the commonly used processing
equipment in the pharmaceutical industries. It is a multi-purpose equipment in that mixing,
granulation and drying are all carried out in the same equipment. The equipment operates in a
bubbling bed regime.[33]
5. Drying:- Drying is a mass transfer process consisting of the removal of water or another
solvent by evaporation from a solid, semi-solid or liquid. This process is often used as a final
production step before selling or packaging products. To be considered "dried", the final
product must be solid, in the form of a continuous sheet (e.g., paper), long pieces (e.g.,
wood), particles (e.g., cereal grains or corn flakes) or powder (e.g., sand, salt, washing
powder, milk powder).[34]
Equipments used for Drying[34]
Equipments general category of instruments used for drying of granules are:-
 Tray Dryers.  Roller or Drum Dryers.

 Tunnel Dryers.  Fluidized Bed Dryers.

 Pneumatic Dryers.  Belt Dryers.

 Rotary Dryers.  Vacuum Dryers.
 Trough Dryers.  Freeze Dryers.
 Bin Dryers.
 Tray Dryer:- A tray Dryer is an enclosed insulated chamber in which trays are placed on top
of each other in trolleys. Tray Dryer are used where heating and drying are essential parts of
manufacturing process in industries such as Chemicals, Dye stuff, Pharmaceutical, Food
Products, Colors etc. The material to be dried either wet or solids are placed in the trays. Heat
transfer is by circulation of hot air by electric heaters or steam in radiator coils. Blower fans
are installed inside to ensure proper circulation and transfer of heat. A control panel to
control the temperature and other parameters is fixed outside the dryer. These dryers are
available in Mild Steel, Stainless Steel or construction. Tray dryer is used for drying of
pigments, food, bakery, electrodes, chemical and plastic powders.[35]
 Tunnel dryer:- The tunnel dryer is a machine where a container (tray) filled with the
material is placed on a trolley or the material is loaded directly on the trolley, and the trolley
is pushed in from the tunnel chamber entrance. The material is dried while being moved
through the drying chamber. Various airflow methods are available for the tunnel dryer, such
as horizontal airflow, vertical airflow and alternating airflow, selected according to factors
such as the material properties and drying conditions.[36]
 Drum dryer:- The drum dryer is commonly used to dry viscous, concentrated solutions,
slurries or pastes on rotating steam-heated drums.1,2 It can also be used to dry concentrated
solutions or slurries that become more viscous or pasty because of flashing or boiling off of
moisture or of irreversible thermo chemical transformations of their content that occur on
their first contact with the hot drum surface.3–5 The viscous slurry or paste is mechanically
spread by the spreading action of two counter-rotating drums into a thin sheet that adheres on
the hotter drum in single drum dryers or split sheets on both hot cylinders in double drum
dryers. The adhering thin sheet of paste is then rapidly dried conductively by the high heat
flux of the condensing steam inside the drum. For very wet slurries that produce wet sheets,
the drying of the wet thin sheet can be further enhanced by blowing hot dry air on the sheet
surface. [37]
 Pneumatic dryers:- Pneumatic/ Flash dryers are direct drying units and are known as
convective dryers. In pneumatic flash drying system particulate solids to be dried travels
through the drying duct along with hot air and it get dried during transport in a hot gas
stream.[38]
 Fluidized bed dryer:- Fluidized bed dryer (also called fluid bed dryer) is a kind of
equipment used extensively in the pharmaceutical industries to reduce the moisture content
of pharmaceutical powder and granules. The equipment works on a principle of fluidization
of the feed materials.[39]
 Rotary dryer:- Rotary dryers are a highly efficient industrial drying option for bulk solids.
They are often chosen for their robust processing capabilities and their ability to produce
uniform results despite variance in feedstock. Rotary dryers work by tumbling material in a
rotating drum in the presence of a drying air. They can also be indirectly heated to avoid
direct contact between the material and processing medium. The drum is positioned at a

slight horizontal slope to allow gravity to assist in moving material through the drum. As the
drum rotates, lifting flights pick up the material and drop it through the air stream in order to
maximize heat transfer efficiency. When working with agglomerates, the tumbling action
imparted by the dryer offers the added benefit of further rounding and polishing the granules.
[40]
 Trough Dryer:- The materials to be dried are contained in a trough-shaped conveyor belt,
made from mesh, and air is blown through the bed of material. The movement of the
conveyor continually turns over the material, exposing fresh surfaces to the hot air.[41]
 Vacuum dryer:- Vacuum drying is a process in which materials are dried in a reduced
pressure environment, which lowers the heat needed for rapid drying. Vacuum dryers offer
low-temperature drying of thermo labile materials and are suitable for solvent recovery from
solid products containing solvents. Heat is usually supplied by passing steam or hot water
through hollow shelves. Drying temperatures can be carefully controlled and, for the major
part of the drying cycle, the material remains at the boiling point of the wetting agent. Drying
times are long, usually about 12 to 48 h. Unlike a direct-heat dryer — in which the material is
immersed directly into the heating media (usually a hot gas stream) and is dried by
convection — a vacuum dryer is an indirect-heat dryer . That is, the heat is transferred to the
material as it contacts the dryer’s heated surface, drying the material by conduction.[42]
 Freeze dryer:- Freeze drying is the removal of ice or other frozen solvents from a material
through the process of sublimation and the removal of bound water molecules through the
process of desorption. Lyophilization and freeze drying are terms that are used
interchangeably depending on the industry and location where the drying is taking place.
Controlled freeze drying keeps the product temperature low enough during the process to
avoid changes in the dried product appearance and characteristics. It is an excellent method
for preserving a wide variety of heat-sensitive materials such as proteins, microbes,
pharmaceuticals, tissues & plasma.[43]
6. Tablet compression:- Tablets are being formed by compressing the granules by using
the compression machine. Tablet formed in compression machine by pressing the granules in
die with lower and upper punch. Tablet formation takes place by the combined pressing
action of two punches (lower and upper) and a die.[44]
The tablet compressing processes, as performed with typical pharmaceutical compressing

equipment, may be divided into four distinct stages. These stages include filling, metering,
compressing, and ejection. Actual tablet formation and control of tablet quality attributes occurs
during the compressing stage.[45]
a) Filling:- The filling stage of the tablet compression process involves transfer of raw
materials into position for tablet compression. These raw materials have undergone prior
processing by wet granulation, dry granulation (roller compaction), sizing, or other
processes. The final formulation is then blended to yield a homogeneous blend. The blend
then flows to the compressing machine punch-die cavity. The punch-die cavity is composed
of punch die and lower punch. The position of the lower punch within the die determines the
volume of the punch-die cavity. This volume must be appropriately sized for the weight of

granulation to be compressed into tablets. The granulation is overfilled on the die table
(turret) to ensure complete filling of the punch-die cavity volume.[45]
b) Metering:- The metering stage of the tablet compressing process involves removal of excess
granulation from the compressing machine. This stage enables the exact weight (volume) of
granulation to be compressed into tablets. The exact weight of granulation is controlled by
the height of the lower punch in the die. The height of the lower punch is controlled by the
metering cam (also called the dosage cam). The lower punch is raised to the appropriate level
in the die to provide the exact weight of granulation in the punch-die cavity. The excess
granulation is scraped from the surface of the die table. The metering stage is similar to the
method used to measure flour when baking a cake. A measuring cup is first over-filled with
flour; then a knife is used to scrape off the excess. The exact amount of flour is then left in
the measuring cup.[45]
c) Compression:- The compression stage of the tablet compressing process forms the tablet.
This stage involves bringing together the upper and lower punches under pressure within the
die to form the tablet. As the punches enter the compressing stage, the upper and lower
punches move between two large wheels called pressure rolls. These pressure rolls push the
punches together to form the tablet. The distance between the upper and lower punches
determines the thickness and the hardness of the tablet. When the punches are close together,
a thin and hard tablet is created. When the punches are farther apart, the tablet made is softer
and thicker. The proper balance of thickness and hardness determines the optimum roll
distance for any specific product. These adjustments are made while keeping the tablet
weight constant.[45]
d) Ejection:- The ejection stage of the tablet compressing process involves removal of the
tablet from the lower punch-die station. In this stage, the upper punch retracts from the die
cavity and rises above the turret table. Then the lower punch rises in the die, which in turn
pushes the tablet upward to the top surface of the die table and out of the die cavity. A
scraper (also called takeoff scraper or tablet rake-off) then pushes the tablet off the die table
away from the compressing machine into the collection container.[45]
Equipment for tablet compression:- The equipment employed for tablet compression is
generally categorized according to the number of compression stations and dislocation mode.
Therefore, eccentric model presses have only one compression station (one die and one pair of
punches, upper and lower) while rotary models have multiple compression stations (each station
with one die and one pair of punches, upper and lower). The basic difference between the two
types of compression equipment is that for eccentric models the compression force applied
during compression is due to the upper punch whereas for rotary models it is mainly applied by
the lower punch. A rotary tablet press machine comprises a housing in which the compression set
and subsets (upper and lower roller assemblies) are mounted, the turret head, the upper cams, the
weight control assembly and the lower cams, the hopper, the feeder assembly, the take - off
chute, the aspiration assembly, the gear box and the electrical unit, and the lubrication system.[46]

[46]
7. Packaging:- Drug packaging is a core element of marketing mix through which

manufacturers differentiate their products from those of their competitors. As new
regulations on packaging focus on increased stability and extended life of drug formulation,
printing or labeling standards protect patient’s compliance for specific tablet or capsule
offered by some companies. Packaging is a means to impart protection of goods for storage
or export whereas labels identify goods intended for immediate sales or transport.[47]
 Drug packaging can be broadly classified into four categories – primary, secondary,
tertiary and quaternary packaging.[47]
 Primary packaging is a material that envelops the product, impart barrier from immediate
environment to protect its activity and holds it.[47]
 Secondary packaging is outside the primary packaging that group primary packs together.
Tertiary packaging is used for bulk storage and transportation, whereas[47]
 quaternary packaging utilizes huge containers for shipment to another territory or port.[47]
Types of packaging for tablets:-

i. Blister packaging:- It is most common and widely accepted world-over as primary pack of
tablets or capsules due to its efficacy and safety considerations. Alternative to blister packs is
strip packaging or glass vial with a sealed cap. The primary component of a blister pack is a
thermoplastic material, thermo adhesive solvent, and lid. A blister pack has a preformed pocket
or cavity of thermoplastic material like PVDC that is heat sealed to a composite lidding material
like aluminum/paper/PET with the help of adhesive.[47]
ii. Strip packaging:- It is an alternative form for unit dose packing that encloses the article
between two webs of material so that each unit is contained in a separate compartment. Strip
packaging is a high speed packaging machine suitable for variety of products like tablets,
capsules, pills. High quality sealing is achieved through precise temperature controllers,
adjustable sealing pressure on rollers, rugged and precise construction. It is suitable for heat
sealable coated films like paper alloy, aluminum films, glassine, cellophane with adjustable
cutting arrangements for knurling, noiseless, trouble free and smooth operation. Web materials
are fed between heat rollers with circumferential cavities of typical size, depth, shape and
thickness. The material to be packed is fed from feed hopper through channels that drop between
the web to meet at the roller cavity.[47]
Thermosealing forms a pocket around the content. Strip design is basic, emerging units that are
invariably rectangular or square strip. Packet can be round, oval or square of different diameter,
size and shape. High speed tablet strip packaging can be fully automated for large quantity of
package, with high work efficiency. Adjustable film feeding system, pin-hole device and
conveying tables can meet requirements of different products. Length of the film or strip can be
controlled or automated, suitable for wide variety of packaging materials.[47]
BMR (Sample)[48]
Company name Batch Manufacturing Record Page:-

Department:- Title:- Paracetamol Tablet Batch Record:-
Production BMR 001
Name Signature Date Revision no.:-
Prepared by: 0
Approved by: Effective date:-
3 November 2020
a. Product Details
Description Paracetamol 650 mg Tablet
Colour:
Shape:
Batch Quantity Batch size:
Approx no. of tablets:
Packaging Blister
Storage Conditions Keep at room temperature
Prevent exposure to direct heat and light
b. Reference Documents
SOP- 001: Non conformances
SOP-009: Line clearance
SOP-033: Temperature and Humidity Monitoring
SOP-004: Facility Cleaning Procedures
SOP-007: Material Weighing and Dispensing
SOP-011: Batch Manufacturing Records
SOP-016: Sieve Shaker
SOP-088: Cube Mixer
SOP-055: Granulator
SOP-012: Tray Oven
SOP-044: Karnavati Tablet Punching Machine
Batch no.: CP03112020 Manufacturing Date: Expiry Date:

03 November 2020 03 November 2022

Production BMR 001
0
Prepared by:
Effective date:-
Approved by: 3 November 2020
c. Raw Materials

Description Part Quantity Lot Qty Exp/Retest Performed Verified

no. required no. Staged by/Date by/Date
PCM(API) P-99
Starch P-80
(potato)
(binder)
Starch P-76
(maize)
(disintegrant)
Magnesium P-32
stearate
Talc P-12
Methyl P-55
Paraben
Propyl P-47
paraben


Production BMR 001

0
Prepared by: Effective date:-
3 November 2020
Approved by:

d. Processing Equipments
Equipment Description ID No. Previous Calibration Performed Verified
Calibration Required by / Date by / Date
Weighing Balance
Sieve shaker
Cube mixer
Granulator
Tray oven
Punching machine
Stainless Steel
Container


Production BMR 001
Prepared by: 0
3 November 2020
e. Production Procedure
Processing Step Performed by/Date Verified by/Date
Dispensing
All raw materials are identified,

correctly weighed and dispensed

Mixing
API, disintegrent and preservatives are
mixed with each other.
Now starch paste is added to the mixture
mentioned above.
Granulation
Blend obtained from above is made into
small granules by granulator.
Obtained granules are dried in tray dryer
Sifting
Granules are sifted and required size
granules are obtained
Punching
Now lubricant and glidant is added to
the granules
Granules are filled in hopper.


Production BMR 001
Prepared by: 0
3 November 2020
Punching machine is
switched on desired
quality tablets of PCM are
obtained and collected in
a container.

Packaging and labelling

Blister packaging is done
as it is most preffered
f. Sampling material transfer and storage
g. Yield Calculation
Yield= (weight of tablets)/(weight of raw materials)*100
=_________(Specification: 95-100%)
Finished Product Yield=100*(No. of goods produced at the end of the process + rejects
+ samples + returned)/(No. of goods received at the start of process)


Production BMR 001
Prepared by: 0
3 November 2020
h. Post Production Review

The complete Post-Production Batch Record has been reviewed for completeness and
accuracy. All pages are complete and all enteries conform to Good Documentation
Practices.
Name Signature Date
Production
Quality Assurance
i. Product Release
The material produced through the execution of this Batch Record shall be
Dispositioned by QA according Product Release Procedure.
The product conforms to Finished Goods Specification: Paracetamol tablet (650 mg)
COA No:__________________ Date:__________________
The disposition shall be recorded below.
Name Signature Date

Production
Quality Control
Quality Assurance


CONCLUSION
A batch manufacturing record is a written record that documents the entire
manufacturing process and the history of a product batch. It records every process
step by step and thus also ensures safety and efficacy of the product. It thus
provides confidence about the product consistency, degree of attribute, and its
quality.
During the preparation of this report I have concentrated on the preparation

of BMR for tablet dosage form. It undoubtedly covers all the topics related to
tablet manufacturing process such as dispensing, sizing, blending, granulation,
drying, tablet compression and packaging.
During preparation of this report I have tried to elaborate each step involved
in the preparation of BMR as much as possible and also to provide the readers a
thorough understanding of each step involved in tablet manufacturing process.

References
1. https://www.presentationeze.com/presentations/quality-assurance-quality-
management/quality-assurance-quality-management-full-details/document-control/batch-
manufacturing-records/#:~:text=A%20batch%20manufacturing%20record%20is,and
%20food%20regulatory%20agency%20requirements.
2. https://www.pharmaguideline.com/2015/05/batch-manufacturing-record-bmr.html
3. https://www.researchgate.net/publication/277014530_Tablet_manufacturing_processs_an
d_defects_of_tablets
4. http://qualityassurancepharma.blogspot.com/2010/12/dispensing-of-raw-materials.html
5. http://resource.npl.co.uk/docs/science_technology/mass_force_pressure/clubs_groups/inst
mc_weighing_panel/pharmaweigh.pdf
6. https://www.hbm.com/en/6768/what-is-a-load-cell-and-how-does-a-load-cell-work/
7. https://www.wordnik.com/words/platform%20scale
8. https://www.adamequipment.com/aeblog/what-are-precision-balances#:~:text=In%20the
%20weighing%20industry%2C%20we,usually%20up%20to%20one%20milligram
%E2%80%9D.&text=Adam%20Equipment%20precision%20balances%20have,0.001g
%20at%20the%20most.
9. https://www.adamequipment.com/aeblog/what-are-analytical-balances
10. https://semi-micro.balances.com/
11. https://www.ktekanalytics.net/micro-ultra-micro-balances.html
12. https://www.horiba.com/en_en/applications/health-care/pharmaceuticals-and-medicine-
manufacturing/particle-characterization-in-the-pharmaceutical-industry/#:~:text=The
%20particle%20size%20distribution%20of,used%20to%20create%20pharmaceutical
%20products.&text=The%20link%20between%20particle%20size,absorption%20rates
%20and%20content%20uniformity.
13. https://bulkinside.com/pharmaceutical-processing/particle-size-distribution-
pharmaceutical-industry/
14. https://www.pharmapproach.com/hammer-mill/
15. https://www.pharmapproach.com/vibration-mill/#:~:text=A%20vibration%20mill%20is
%20a,out%20its%20size%20reduction%20function.&text=Vibration%20mills%20are
%20similar%20to,balls%20and%20the%20mill%20body.
16. https://www.pharmapproach.com/roller-mill/
17. https://www.pharmapproach.com/pin-mill/
18. https://www.pharmapproach.com/fluidized-energy-mill/
19. https://www.pharmapproach.com/edge-runner-mills-and-end-runner-mills/
20. https://www.pharmapproach.com/cutter-mill/
21. https://www.pharmapproach.com/ball-mill/

22. https://www.customprocessingservices.com/blog/critical-things-to-know-about-
pharmaceutical-blending-process#:~:text=Many%20industries%20rely%20heavily%20on
%20mixing%20and%20blending%20technology%20to%20create
%20products.&text=Typically%20in%20the%20pharmaceutical%20industry,lactose%2C
%20starch%2C%20or%20lubricants
23. https://www.pharmapproach.com/pneumatic-mixers/#:~:text=Pharmaceutical%20uses
%20of%20pneumatic%20mixers,-1.&text=Pneumatic%20blenders%20are%20best
%20used,dry%20and%20free%20flow%20powders.
24. https://www.pharmapproach.com/diffusion-mixers/#:~:text=Diffusion%20mixers%2C
%20also%20known%20as,motor%20at%20an%20optimum%20speed.&text=The
%20charging%20method%20used%20in%20charging%20the%20powder.
25. https://www.pharmapproach.com/convective-mixers/
26. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4401168/#:~:text=Granulation%2C
%20the%20process%20of%20particle,that%20are%20easy%20to%20compress.
27. https://www.pharmamanufacturing.com/articles/2008/096/
28. https://www.pharmapproach.com/manufacture-of-tablets-by-dry-granulation-method/
29. https://www.pharmapproach.com/tablet-manufacture-wet-granulation-
method/#:~:text=Wet%20granulation%20method%20is%20a,ethanol%20(or%20mixtures
%20thereof).
30. https://www.pharmapproach.com/manufacture-of-tablets-by-dry-granulation-method/
31. https://appliedchemical.com/resources/more-info/granulation/what-is-granulation/
32. https://sci-hub.se/10.1016/S0167-3785(07)80039-X
33. https://www.pharmapproach.com/fluidized-bed-granulator/#:~:text=Fluidized%20bed
%20granulator%20is%20one,in%20a%20bubbling%20bed%20regime.
34. https://www.researchgate.net/publication/318114026_Effect_of_Size_Reduction_and_Dry
ing_Technology_on_Granules_Production
35. https://pharmawiki.in/tray-dryer-working-principle-tray-dryers-theory-manufacturer-best-
pharmaceutical-equipment/
36. http://www.yamato-sanko.co.jp/english/products/tunnel_dryer/#:~:text=The%20tunnel
%20dryer%20is%20a,moved%20through%20the%20drying%20chamber.
37. https://www.researchgate.net/publication/265654124_9_Drum_Dryers/link/56c3d88608ae
e3dcd4167d3a/download
38. http://www.kerone.com/pneumatic-flash-dryer.php
39. https://www.pharmapproach.com/fluidized-bed-dryer/#:~:text=Fluidized%20bed%20dryer
%20(also%20called,fluidization%20of%20the%20feed%20materials
40. https://feeco.com/rotary-dryers/
41. https://www.google.com/search?q=vacuum%20dryer
%20diagram&tbm=isch&rlz=1C1CHZL_enIN735IN735&hl=en&sa=X&ved=0CB8QtI8
BKABqFwoTCNC5nJDmzO0CFQAAAAAdAAAAABAS&biw=1349&bih=657#imgrc=
zpaXa_BHHsi2cM

42. https://www.researchgate.net/publication/283088611_Vacuum_Drying_Basics_and_Appli
cation
43. https://www.spscientific.com/freeze-drying-lyophilization-basics/
44. https://pharmapathway.com/working-and-principle-of-tablet-compression-machine/
45. https://www.ivtnetwork.com/sites/default/files/Fundamentals_Tablet_Compression_0.pdf
46. https://sci-hub.st/https://onlinelibrary.wiley.com/doi/abs/10.1002/9780470571224.pse367
47. http://www.pharmabiz.com/NewsDetails.aspx?aid=90432&sid=21
48. https://asean.org/storage/2012/10/ASEAN-TMHS-GMP-Training-Chapter-5-Annex-5-
Sample-Batch-Manufacturing-Record.pdf

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Practice School Report TOPIC:- BMR

SHRI RAM MURTI SMARAK COLLEGE OF

Practice School Report

UNDER GUIDANCE OF: - SUBBMITED BY:-

SRMS CET (PHARMACY), Bareilly, U.P. 1

B. Pharm ( 7th sem )

SRMS CET (PHARMACY), Bareilly, U.P. 2

SRMS CET (PHARMACY), Bareilly, U.P. 3

 Dates of start and finish of manufacture.

Batch Manufacturing Records must be:

SRMS CET (PHARMACY), Bareilly, U.P. 4

1. Dispensing of raw materials:-

Objective: To provide guidelines for dispensing of raw materials.[4]

Scope: This procedure applies to dispensing of raw materials in stores department.[4]

Follow up:- Officer – Stores[4]

Overall responsibility:- Store In-charge.[4]

 No other material is present in the area

SRMS CET (PHARMACY), Bareilly, U.P. 5

o Name of the Material o Tare Wt

SRMS CET (PHARMACY), Bareilly, U.P. 6

 Stock Register in Raw Material.

MATERIAL REQUISITION NOTE Sr. No.

Name of Product: ____________________________________ Stage No.: ______________

Batch No.: ________________ Batch Size: ________________Kg Mfg. Date: _____________

Sign & Date Sign & Date Sign & Date

Sign & Date Sign & Date Sign & Date

SRMS CET (PHARMACY), Bareilly, U.P. 7

SRMS CET (PHARMACY), Bareilly, U.P. 8

Microbalances will normally have a capacity of less than 1 g and a resolution of at

SRMS CET (PHARMACY), Bareilly, U.P. 9

SRMS CET (PHARMACY), Bareilly, U.P. 10

SRMS CET (PHARMACY), Bareilly, U.P. 11

4. Granulation:- Granulation, a technique of particle enlargement by agglomeration, is one

SRMS CET (PHARMACY), Bareilly, U.P. 12

SRMS CET (PHARMACY), Bareilly, U.P. 13

Differences between wet granulation and dry granulation methods[30]

SRMS CET (PHARMACY), Bareilly, U.P. 14

 Rotary Drum Granulator  Pan Granulator

 Tray Dryers.  Roller or Drum Dryers.

SRMS CET (PHARMACY), Bareilly, U.P. 15

 Pneumatic Dryers.  Belt Dryers.

SRMS CET (PHARMACY), Bareilly, U.P. 16

The tablet compressing processes, as performed with typical pharmaceutical compressing

SRMS CET (PHARMACY), Bareilly, U.P. 17

SRMS CET (PHARMACY), Bareilly, U.P. 18

7. Packaging:- Drug packaging is a core element of marketing mix through which

Types of packaging for tablets:-

SRMS CET (PHARMACY), Bareilly, U.P. 19

Company name Batch Manufacturing Record Page:-

Batch no.: CP03112020 Manufacturing Date: Expiry Date:

Company name Batch Manufacturing Record Page:-

SRMS CET (PHARMACY), Bareilly, U.P. 21

Description Part Quantity Lot Qty Exp/Retest Performed Verified

Batch no.: CP03112020 Manufacturing Date: Expiry Date:

Company name Batch Manufacturing Record Page:-

Name Signature Date Revision no.:-

SRMS CET (PHARMACY), Bareilly, U.P. 22

Batch no.: CP03112020 Manufacturing Date: Expiry Date:

Company name Batch Manufacturing Record Page:-

SRMS CET (PHARMACY), Bareilly, U.P. 23

correctly weighed and dispensed

Batch no.: CP03112020 Manufacturing Date: Expiry Date:

Company name Batch Manufacturing Record Page:-

Name of Product: ______________________ Stage No.:

Batch No.: ____ Batch Size: Kg Mfg. Date: _