INTRODUCTION

In Bangladesh the pharmaceutical sector is one of the most developed hi-tech sectors which are
contributing in the countrys economy. After the promulgation of Drug Control Ordinance 1982,
the development of this sector was accelerated. The professional knowledge, thoughts and
innovative ideas of the pharmacists working in this sector are the key factors for these
developments. Due to recent development of this sector it is exporting medicines to global market
including European market. This sector is also providing 97% of the total medicine requirement of
the local market. Leading pharmaceutical companies are expanding their business with the aim to
expand export market. Recently few new industries have been established with high tech
equipments and professionals which will enhance the strength of this sector.
Rangs Pharmaceuticals Ltd is one of the leading Companies in Pharmaceuticals sector. After all
necessary arrangements it launched its production on 2004 with 12 products which were mainly
antibiotic and anti ulcerants. There after it did not look back. At present it manufactures 120
important products.

SOLID DOSAGE FORM MANUFACTURING:

TABLET DEPARTMENT
Tablet:
Tablet manufacturing unit one of the most important unit in the production area of a
pharmaceutical company. Tablet can be defined as a solid pharmaceutical dosage form
containing active drug substances and excepients & prepared either by compression or molding
method (according to NF). In Rangs pharmaceuticals Ltd, solid section is the biggest section of
all. Solid section provides about 70% of the total turn over per year. By this way this unit plays a
vital role in the financial aspects of the company.
Major steps of tablet manufacturing:

Granulation

Compression

Coating

Tablet manufacturing area:

a. Dispensing area
b. Granulation area
c. Blending area
d. Compression area
e. Coating area
Dispensing Area:

Dispensing
Dispensing means to supply materials to the production area by proper weighing according to the
relevant document and release it from the raw materials store.
Weighed raw materials from warehouse are also rechecked here.
Machine for Dispensing:
Electronic Balance
Granulation Area:
Granulation:
The process, by which the primary active ingredients and excepients powder particles are made
to adhere to form larger multi particles, is called granulation.
Granules size range for pharmaceuticals: 0.2-4
Types of granulation:
1)

Wet granulation

2)

Dry granulation

3)

Direct compression

In Rangs Pharmaceutical only wet granulation and direct compression are done.
Purpose for granulation:

To prevent segregation of the constituents of the powder mixture

To improve the flow properties of the mixture

To improve the compaction characteristics of the mixture

Process of wet granulation

Raw material screening through the vibratory sifter
Mixing of active ingredients with excepients
Wet mass
Pass through Grating & Shredding machine
Drying
Sieving
Blending with lubricant
Machine:
1. Tablet mixing machine
Rapid mixer granulator
Model-RMG-400
Capacity-120 kg
Clit
Origin-Germany

2. Multimiller
Clit
Origin-Germany
3. Fluidized bed dryer
SOLACE AERO DRYER
Capacity-120 kg
Blending Area
Blending:
Blending is the process of uniformly mixing the ingredients so that each tablet contains the unit
amount of dosage.
Machine:
1. 1.

Double Cone blender

MARK
Model-DCB-600
Capacity-120 kg
Origin-Bangladesh
Compression Area
Compression:
The process of forming tablets in desired shapes compressing by sufficient pressure.
Factors to be considered during compression:
Temperature
Relative humidity
Compression Machine:
200GMP-SQUARE MODEL
Model-CPM D3
Capacity-130000
Running capacity-50000
Clit
Origin-Germany
200GMP SQUARE MODEL
Model-CPM B3B
Capacity-130000
Running capacity-78000
Clit

Origin-Germany
Coating Area
Coating:
A layer of a substance spread on the surface of the core tablet. Sugar coating was popular in
past but it has many drawbacks. Modern tablet coating is polymer and polysaccharide based,
with plasticizers and pigments included.
Types of coating:
1. Film coating

Organic solvent based

Aquous solvent based
1. Sugar coating
2. Enteric coating

In Rangs pharmaceuticals only film and enteric coating is performed.

Steps of Film coating:

Solvent

- Organic
- Aquous

Polymer

Plasticizer

Optional ingredients

Anti-foam agent
Colorant
Weight gain for different coating:

Film coating

: 2-3%

Enteric coating

:3.5-6%

Coating Machine:
1. 1.

NR Cota 29 Film coating machine

Model-FC-29
Capacity-20-30 kg
Origin-England
1. 2.

NR Cota 39 Film coating machine

Model-FC-39
Capacity-120 kg
Origin-England
Tablet Preparations in Rangs PharmaceuticalBrand Name

Generic name

Alverin Tablet

Alverine citrate

Ancotil 3 Tablet

Bromazepam

Antiplate Tablet

Clopidogrel

Antipro Tablet

Metronidazole

Colamin Tablet

Mecobalamine

Destacin Tablet

Desloratadine

Depresil Tablet

Flupenthixol
Melitroacen Hydrochloride

Depanil-0.5 Tablet

Clonazepam

Depanil-2 Tablet

Clonazepam

Gatiquin 400 Tablet

Gatifloxacin INN

Kenodol-10 Tablet

Ketorolac Tromethamine

Lethiquin 500 Tablet

Levofloxacin Hemihydrate

Lipicut-10 Tablet

Atorvastatin Calcium

Lipicut-20 Tablet

Atorvastatin Calcium

Monprox 10 Tablet

Montelukast Sodium

Normogat 10 Tablet

Domperidone Maleate

NT-par 400 Tab

Albendozole

Ostacid D Tablet

Calcium Carbonate Heavy USP

Vitamine D3

Ostacid D Tablet

Calcium Carbonate Heavy USP

Vitamine D3

Ostacid 500 Tablet

Calcium Carbonate Heavy USP

Omag DR Tablet

Omeprazole Magnesium

Orafen SR Tablet

Diclofenac Sodium BP

Pivcilin Tablet

Pivmecillinam HCL

Ranflox 500 Tablet

Ciprofloxcin HCL

Ranflox 750 Tablet

Ciprofloxcin HCL

Ranvit-B Tablet

Thiamine HCL
Riboflavine 5 Phosphate Sodium
Pyriodoxine HCL (Vitamine B6)
Nicotinamide

Ranzith-500 Tablet

Azithromycin Dihydrate (USP) Micronized

Ranoxen 250 Tablet

Naproxen Sodium

Ranoxen 500 Tablet

Naproxen Sodium

Rampil 2.5 Tablet

Ramipril

Rampil 5 Tablet

Ramipril

Recofast 125 Tablet

Cefuroxime Sodium For Recofast Tablet

Recofast 250 Tablet

Cefuroxime Sodium For Recofast Tablet

Recofast 500 Tablet

Cefuroxime Sodium For Recofast Tablet

Redema 20 Tablet

Spironolactone
Furosemide

Redema 40 Tablet

Spironolactone
Furosemide

Sartec Tablet

Cetirizine Di Hydrochloride

Sedaquil 7.5 Tablet

Midazalam Maleate

Vesocal-5 Tablet

Amlodipine Besylate

Vesocal-10 Tablet

Amlodipine Besylate

Vesocal Plus

Amlodipine Besylate
Atenolol

Vesotan-8 Tablet

Candesartan Cilexetil

Vesotan-16 Tablet

Candesartan Cilexetil

Vesodil 6.25 Tablet

Carvedilol

Vesodil 12.5 Tablet

Carvedilol

Vesodil 25 Tablet

Carvedilol

Veramil-80 Tablet

Verapamil HCL

Veramil SR Tablet

Verapamil HCL

X-pectoran- 8 Tablet

Bromhexine Hydrochloride

Zenil-150 Tablet

Ranitidine Hydrochloride USP

Diversa Gold Tablet

Vitamin A Palmitate
Beta carotene 20% Dry Powder
Ascorbic Acid (Vit C)
Vitamin D3
Vitamin E
Vitamin K
Thiamine Mononitrate(Vit B1)
Riboflovin (Vit B2)
Nicotinic Acid (Niacin)
Pyriodoxine HCL (Vitamine B6)
Folic Acid
Cyanocobalamin (Vitamine B12)
Biotin

Calcium Pantothenate (Pantothenic Acid)

Calcium Carbonate Heavy USP
Dried Ferrous Sulphate (Iron)
Di Calcium Phosphate (Phoshorous)
Potassium Iodide (Iodine)
Magnasium Oxide (Magnesium)
Zinc Oxide (Zinc)
Sodium Selenate Anhydrous (Selenium)
Cupric Oxide (Copper)
Manganese Sulphate (Manganese)
Chromic Chloride (Chromium)
Sodium Molybdate (Molybdenum)
Sodium Chloride for Vitamine Product (Chloride)
Potasium Chloride (Potassium)
Boron Citrate (Boron)
Nickel Sulphate (Nickel)
Silicon Dioxide (Silicon)
Stannous Chloride (Tin)
Sodium Metavandate (Vanadium)
Lutein 5%

CAPSULE MANUFACTURING DEPARTMENT

ENCAPSULATION
According to the USP, capsules are solid dosage forms in which the drug is enclosed in either a
hard or soft, soluble container or shell of a suitable form of gelatin.
Derived from the diminutive of the Latin word capsa meaning box, a capsule is literally a little
box and can refer to any encompassing structure or small container.

Capsules are two types

1. Hard gelatin capsule
2. Soft gelatin capsule

In Rangs Pharmaceuticals Hard gelatin capsules are produced. In which, the active is failed an
the empty hard gelatin capsule shell in form of

Powder

Pellets

In Rangs Pharma powder are encapsulated with the help of semi automatic feeling machine and
liquid is encapsulated with automatic capsule filling machine.
Capsule Preparations in Rangs Pharmaceutics:
Brand Name

Dose

E-gold
Antif
Curacid

250, 500mg
20, 40mg

Droxil

500mg

Fungitrol

50, 150mg

Lindex

250, 500mg

Maxflo-U
Ngcef

200mg

Perpen

250,500

Prevencid

20,40mg

Pregmin
Pregmin-Z
Process of capsule manufacturing (powder):
Station having two parts upper plate and lower plate with negative air pressure collect shell from
shell channel where cap remain at the top and body remain at the bottom.

Upper plate contain cap and lower plate Contain body

Lower plate goes feeding channel

Body of capsule filled with Powder

Both plates close to each other

Finally at the end of Encapsulation operation shut down the machine

Checking and polishing

Packaging

In this section pellets are encapsulated with the help of semi automatic filling machine.
Process of capsule manufacturing (Pellets):

Capsule shell in the hopper

Shell channel

Station having two parts upper plate and lower plate with negative air pressure collect shell from
shell channel where cap remain at the top and body remain at the bottom

Upper plate contain cap and lower plate Contain body

Lower plate goes feeding channel

Body of capsule filled with pellets

Both plates close to each other

Finally at the end of Encapsulation operation shut down the machine

Checking and polishing

Packaging

Machine
1. 1. Cone blender

MARK
Model- DCB-406
Capacity- 160kg/B
Origin- Bangladesh
1. 2.

Semi automatic capsule filling machine

P+am
Model- SA-9
Capacity- 25000 capsule/Hr
Origin- India
1. 3.

Polishing & Cleaning machine

Hoonga- A Corporation
Origin- Korea
Problem may arise during encapsulation:
Weight variation
Capsule shell may be brittle when room condition is not maintained
E- Gold
It is a new technology that Rangs Pharmaceuticals has incorporated to product Licap. Only 3
companies at this moment manufacturing this product. Rangs Pharmaceuticals is one of those.
This product is also very effective.
E-Gold 200 Licap:
Each Liquid Filled Hard Gelatin Capsule contains Vitamin E
200 mg (as alpha-Tocopheryl Acetate BP).
Advantages over soft gelatin capsule:

Improve Bioavailability

Economic

Materials use for E-Gold preparation:

Vitamin E (Alpha tocopheryl)

Soyabean Oil

BHT

E.H.G Capsule Shell #1

Gelatin

Green Lake Color

Tween 80

Purified Water

Process of E-Gold production:

1.

I.

2.

II.

E-Solution preparation
Bending solution preparation

E-Solution is prepared by following process:

BHT is added in soybean oil in a beaker
Heating
Cooling
Adding this solution in vitamin E
Filter
Banding solution preparation:
Banding solution is prepared by following process:
Gelatin is added in water
Take them 30 min
Stirring
Tween 80 is added (30 min)

Taken in water bath (40 min or 1 hour)

Color is added

Left them over 1 night at 50C temperature

Process of E-Gold manufacturing:

E-Gold manufacturing is done by automatic capsule filling and banding machine.
The process is following:
Check the room condition
Obtain QA report for capsule filling
Use the right capsule shell #1
Adjust the machine
Start filling
Keep record of starting time and finishing time
Finally at the end of encapsulation operation shut down the machine

Transfer filled capsule to the bend sealing area pass through the automatic bend sealing
machine
Checking and polishing
Packaging
Problem may arise during E-Gold manufacturing:
Bubble Formation
Banana Effect
Machine
1. 1.

Automatic Capsule Filling Machine

P+am
Model- LF-40
Capacity- 40000/hr
Origin- India
1. 2. Automatic Capsule Bending & Sealing Machine

P+am
Model- BS-40
Capacity- 40000/hr
Origin- India
SOLID PACKAGING:
The terminal stage of the production is packaging. This is the terminal stage at which a finished
product gets a shape for marketing purpose. Proper packaging maintains the integrity of the
pharmaceuticals. It should preserves drug efficacy as well as its purity, identity, potency and
quality for its entire shelf life. The selection of package therefore begins with the determination of
the products physico-chemical properties, its protective needs and marketing requirements.
Packaging materials are of two types:
1. 1. Primary packaging materials

PVC

Aluminum foil
1. 2. Secondary packaging materials

Printed box

Leaflet

Labels

Outer

Printed tape

Liner

There are two types of packing:

1. 1.

Blister packing

2. 2.

Strip packing

Only Blister packing is done in this section.

Blister Packing:
Usually tablets and most of the capsules is blister packed in this case, at first the PVC/PVDC
/Aluminum foil is heated by heating plate. The packets are produced by the air pressure and
immediately cooled. At the next stage tablets/capsules are filled into the pockets are pockets and
the aluminum foil is sealed over the PVC/PVDC/ALU film by heating. Finally the blister pack cut
into suitable size.
There are 3 types of Blister:
1. 1.

Alu-PVC blister

2. 2.

Alu-Alu blister

3. 3.

Alu-PVDC

Process of Packaging:
Blister forming
Tablet filling
Sealing the blister with printed alu- foll
Printing of batch no. & Exp. Date
Cutting into individual blister pack
Visual inspection
Packing
Warehouse after QA approval
Machine
1. 1.

Blister Packaging Machine

Hoonga
Model- MINISTER-VAL
Hoonga-A-Corporation
Origin- Korea
1. 2.

Blister Packaging Machine

Hoonga
Model- MINISTER-V
Hoonga-A-Corporation
Origin- Korea
1. 3.

Topical Blister Packager

Model- DPR-250
RUIAN JIANGHUA MACHINERY.CO. Ltd

Origin- China
LIQUID MANUFACTURING DEPARTMENT

Introduction
Liquid preparations are solution containing one or more chemical substances dissolved in a
suitable solvent or mixture of muyually miscible solvent.

Liquid dosage form include

Syrap

Suspension

Emulsion

Paediatric Drops

Granules for suspension

Eye Drops

Liquid preparation in Rangs Pharmaceutical

Product

Pack size

Antif P.D

5 ml

Droxil P.D

5 ml

Lindex P.D

5 ml

Xepodox P.D

5 ml

Product

Pack size

Antif-DS

100 ml

Antif-GS

100 ml

Droxil-GS

100 ml

Lindex-GS

100 ml

Lindex-DS

100 ml

Pedicin-GS

100 ml

Ngcef-GS

50 ml

Perpen-GS

100 ml

Recofast-GS

70 ml

Ranzit-GS

35 ml

Xepodox-GS

50 ml

Eanzith-GS

30 ml

Fungitrol-GS

35 ml

Product

Pack size

Antipro Suspension

60 ml

NT- per Suspension

40 ml

Normogut Suspension

100 ml

Ranvit-B Syrup

100 ml

Ranvit-B Syrup

200 ml

Sartee Syrup

60 ml

X-pectoran Syrup

100 ml

Babiz Syrup

100 ml

Babiz Syrup

200 ml

Laxativ Solution

100 ml

Laxativ Solution

200 ml

Syrup
Syrups are concentrated aqueous preparations of a sugar substitute with or without flavoring
agents and medicinal substances.
Syrups provide a pleasant means of administering a liquid form of a disagreeable- testing drug.

Main ingredients of Syrup

Without the water and active ingredient syrup contains the following ingredients

The Sugar, usually sucrose, or sugar substitute used for sweetness and viscosity.

Antimicrobial Preservatives

Flavoring agent

Coloring agent

STEPS OF SYRUP PREPARATION:

Dispensing

Manufacturing

Storage

Test sample given to QC

After QC passed the sample, start filling and sealing.

Packaging

Suspension:
Suspension is the process of preparing homogenous two phase system in which the internal or
dispersed phase is solid and the external or continuous phase is liquid.

Steps of Preparation:
Carefully tare the container
Finely powder any ingredients not already in fine powder.
Mix the insoluble powder in a mortar
Adding first the ingredients of smallest bulk and diluting it with others increases order of bulk,
using amount equal to the bulk already in the mortar.
Add enough vehicles to produce a smooth paste.
Add, in small amounts, any non volatile solid ingredients, dissolved in part of the vehicle, and mix
well.
If necessary, dilute with the vehicle until pourable.
Examine the suspension critically.
Before use, rinse the fabric with a little vehicle to detouch loose fibers.
Strain into the tared bottle.
Add any volatile solid ingredients, previously dissolved in some of the vehicle, and mix well.
Add any liquid ingredients, rinse the measures and mix well after each edition.
Rinse the mortar and pestle with successive volumes of vehicle until they are quite clean,
transferring the rinsing to the bottle.
Make up to volume with the vehicle and shake thoroughly.
Then the sample is given to the QC for test.
Filling and Sealing.
Packaging
Equipment used in Liquid Section in Rangs Pharmaceutical:

Syrup Preparation Vessel

Eulsifier-1

Eulsifier-2

Semi Auto Liquid Filling Machine

Semi Auto Cap Sealing Machine-1

Conveyer Table-1( Liquid )

Bottle Washing Machine

Bottle Dryer

Colloid Mill

Transfer Pump

DM Plant

Distilled Water Plant (120 L)

Distilled Water Plant (40 L)

Liquid Filtration Unit

Dry Syrup Section:

Mechanical Sifter-2

Double Cone Blander-2

Semi Auto Powder Filling Machine

Semi Auto Cap Sealing Machine-2

STERILE PRODUCTS MANUFACTURING

Parenteral products:
In Rangs Pharmaceuticals Parenteral products are prepared as sterile product. As Parenteral
products are given directly to systemic circulation so sterility is a must.
Environmental conditions that are maintained in sterile product manufacturing:
Air:
The air of the sterile product manufacturing area should be strictly maintained. There are some
air classifications for the manufacturing area to maintain CGMP. This areAir Classifications
Clean Area
Classification

ISO
Designation

(0.5 um

>m

Microbiological

Microbiological

particles/m0.5

Active Air

Settling Plates

Action

Action

Levelsc(cfu/m3 )

Levelsc,d(diam.

particles/ft3)

90mm; cfu/4
hours)
100

3,520

1e

1e

1000

35,200

10,000

352,000

10

100,000

3,520,000

100

50

HVAC system:
HVAC is an acronym for Heating ventilation and air conditioning system and is sometimes
referred to as climate control. The system helps to control humidity and temperature of the air

within a building and are responsible for maintaining pressure relationships between spaces,
ensuring smoke control. HVAC system works, primarily to provide healthy and comfortable
interior conditions and are well designed to perform the task with minimal energy consumption
and air, water pollutant emissions.
Use of HVAC System
Heating: Heating technology makes use of equipments such as a boilers, forced air gas
furnace, heat pumps and radiant floor heat to heat the environment or interiors.
Cooling: Cooling technology includes equipments such as central and room conditioning,
chillers, desiccant dehumidifiers and absorption cooling for various buildings.
Air ventilation and quality: This includes using equipments such as variable air volume
systems (VAV), Low-pressure-drop ducting design, lowface-velocity air handlers etc for high
efficiency air distribution system.
HEPA Filter:
A high efficiency particulate air or HEPAfilter is a type of high-efficiency air filter.
Function
HEPA filters can remove at least 99.97% of airborne particles 0.3 micrometers (m) in diameter.
Particles of this size are the most difficult to filter and are thus considered the most penetrating
particle size (MPPS). Particles that are larger or smaller are filtered with even higher efficiency.
HEPA filters are composed of a mat of randomly arranged fibres. Key metrics affecting function
are fibre density and diameter, and filter thickness. The air space between HEPA filter fibres is
much greater than 0.3 m. The common assumption that a HEPA filter acts like a sieve where
particles smaller than the largest opening can pass through is incorrect. Just as for membrane
filters, particles so large that they are as wide as the largest opening or distance between fibres
cannot pass in between them at all. But HEPA filters are designed to target much smaller
pollutants and particles are mainly trapped (they stick to a fibre) by one of the following three
mechanisms:
Interception, where particles following a line of flow in the air stream come within one radius of a
fibre and adhere to it.
1. Impaction, where larger particles are unable to avoid fibres by following the curving contours of the
air stream and are forced to embed in one of them directly; this effect increases with diminishing
fibre separation and higher air flow velocity.
2. Diffusion, an enhancing mechanism is a result of the collision with gas molecules by the smallest
particles, especially those below 0.1 m in diameter, which are thereby impeded and delayed in
their path through the filter; this behaviour is similar to Brownian motion and raises the probability
that a particle will be stopped by either of the two mechanisms above; it becomes dominant at
lower air flow velocities.

Diffusion predominates below the 0.1 m diameter particle size. Impaction and interception
predominate above 0.4 m. In between, near the 0.3 m MPPS, diffusion and interception
predominate.
Dehumidifier:
A dehumidifier reduces the level of humidity in the air, usually for health reasons, as humid air
can cause mold and mildew to grow inside homes, which has various health risks. Relative
humidity is preferably 30 to 50%. Very high humidity levels are also unpleasant for human beings,
can cause condensation .
In pharmaceutical industry,dehumudifier is used o control the humidity of the manufacturing area.
A/C
Air conditioners automatically act as dehumidifiers when they chill the air and thus need to handle
the accumulated water as well. Newer window units use the condensing coil and fan to evaporate
the accumulated water into the outdoor air, while older units simply allow the water to drip
outside. Central air conditioning units need to be connected to a drain.
Laminar air flow:
An airflow moving in a single direction and in parallel layers at constant velocity from the
beginning to the end of a straight line vector.
In Rangs Pharmaceuticals, the filling and sealing of the injectables are done under the laminar
air flow to control contamination.
One way entry & exit:
One way entry & exit should be maintained. Because there is a possibility of the product to be
contaminated.The products are passed via the passbox from one room to another room. This is
also very important to maintain the sterility of the product.
Areas of Injectables:

1 change room

Final dressing room

Air shower

Material washing area

Liquid processing unit

Ampoule filling & sealing unit

Air lock pass box

Terminal sterilization

st

nd

washing room

Process maintained in sterile product manufacturing unit:

In the previous day of manufacturing, the packaging matrialals are collected and sterilized by-

Dry heat sterilization

Moist heat sterilization

Bun washing machine

To make pyrogen free of certain products, 250 c temperature is maintained for about 90 minutes.

In moist heat sterilization, 121 c is mainained for 20-25 minutes.

The production area is cleaned time to time by isopropyl alcohol.

In the previous day of manufacturing, fumigation is done by 50% water and 50% formaldehyde

The UV ray is passed over the night-before manufacturing.

About 45% humidity and 25 c temperature is maintained in the vial filling room.

After filling and sealing, the products are transformed into intermediate store area.

Blister packaging is done in the Rangs pharmaceuticals for injectables.

Sterile products of Rangs Pharmaceuticals

Product
Lindex- 1g

Pack size
IV/IM..1s

Lindex- 500mg IV/IM.5s

Maxbac 250mg IV/IM.1s
Maxbac 500mg IV/IM.1s
Maxbac 1g

IV/IM .1s

Oryx 250mg

IV...1s

Oryx 500mg

IV ..1s

Oryx 1g

IV ...5s

Oryx 250mg

IM...1s

Oryx 500mg

IM .1s

Oryx 1g

IM . 1s

Oryx 2g

IV ..1s

Recofast 750 IV/IM .1s

Kenodol-30 injection ...6s
Orafen Plus injection ..2X5s
QUALITY ASSURANCE
ADMINISTRATION ORGANOGRAM:

Director

Manager, QA & QC

Asst. Manager, QA

Senior Officer

Officer

Quality Assurance:
Quality Assurance is a wide-ranging concept, which covers all matters that individually and or
collectively influence the quality of a product.

The impact of total quality maintenance is

Improved operating procedure

Greater customer satisfaction

Increased financial performance

Purpose:
GMP is that of quality assurance which ensures that, products are consistently producer and
controlled to the quality stander appropriate to their intended use and as required by marketing
authorization. A product specification this makes it clear that QA in the Generic, wider term.
The function of Q.A. in different section of the industry:
1. Ware House:
1. Receiving raw material & packaging material only by visual inspection
2. Attachment of Quarantine & sampled tag by proper sampling rule
3. Sampling rule : If the no. of pack is within 24 than no. of sampled = N +1
4. Sampling for :

Assay

Microbial test

Retention sample
5. Released or rejection of raw materials & packaging materials

2. Production Area:
In liquid Only the physical inspection of
Cleanliness
Maintenance of BPR in production
Packaging
In solid
Cleanliness of the area instrument by Physical inspection.
In process QA checked :
Hardness
Thickness
Weight variation
3. Packaging Area:
During packaging QA checked:
Humidity of the packaging area
Leak test (in case of bottle tilling)
Appearance of tablet & cap
Labeling of stripper & inner & outer cartoon.

QUALITY CONTROL

Quality Control
The regulatory process, through which industry measures actual quality performance, compares
it with standards and acts on the difference.
Q.C. activities
Quality control is responsible for the day by day control of quality within a company. This
department is stuffed with scientist and technicians who assess and assure that entire production
process has been completed satisfactorily and satisfied all the aspects of GMP.
Protocol for quality control assignment
Sampling
(A quality assurance officer
does it & brings it to the Q.C department )
Supervising
(A representative from the Q.C. dept.
receives the sample & assign someone to analyze.)
Analysis
(The analyst analyses the sample
according to the specification)
Checking
(After the tests, the results are checked)
Final approval
(The Q.C. manager verifies the result)
Collection
(Q.A. officer collects the results
of the sample that was assigned
previously. )
Instrumentation of Q.C. Department:
1. HPLC (high performance liquid chromatography)
This is used for product identification & assay.
Machine: 1. Shimadzu.
2. IR spectrophotometer
This is used for product identification. It acts as a comparison with the standard & the sample.
Machine : 1. Shimadzu ( IR Prestige-21 ).
3. UV-Visible spectrophotometer

This is used for product identification .It concomitantly read the absorbances of standard &
sample preparations.
Machine : 1. Shimadzu ( UV-1650PC ).
4. Karl-Fischer titrator
-It determines the water content of the sample.
Machine : Schott(Germany)Titroline KF
5. pH meter
-It is used to determine the pH value.
Machine : HANNA Instrument.
6. M.P.apparatus.
It determines the melting point of the sample.
Machine : 1. Gallenkamp (England).
7. USP dissolution test apparatus
It tests the solubility of the tab in definite medium, which gives the idea of the absorbing of the
tablet by human body.
Machine : Electrolab (TDT-08L).
8. USP disintigration test appartatus
-It tests the separation of the particle of sample in a definite medium.
Machine : Electrolab (ED2L).
9. Chemical Balance ( Sartorious).
10.Drying oven ( Memmert ).
11. Microscope
12. Hot Plate ( Nova )
13. Centrifuger ( Centrifuge-800 )
14. Oven ( Memmert )
15. Vortex mixer (VM-2000)
16. Humidity Control Chamber ( Shel lab, USA )
17.Water Bath (Memmert)
18.Leak Test Apparatus.
Apparatus for MICROBIAL TESTS

Autoclave ( Tomin, Taiwan )

Incubator. { Memmert ( 30-90c)

Machine for laminar flow ( Air Tech)

Oven

Air Sampler (Sartorius)

Air Borne Particle Counter (Climet)

Sterility Test Apparatus.

MICROBIOLOGY DEPARTMENT:
Involvement of Microbiology in major areas:

Quality Control laboratory

Quality Compliance ensuring GMP

Quality Assurance of sterile products

Method development as Apart of Product development

Cleaning validation

TESTS DONE BY MICROBIOLOGY DEPARTMENT

Sterile Product Testing:

Sterility test

Bacterial Endotoxin test

Microbiological immersion studies

Microorganism identification

Non-sterile Product testing:

Microbial limit test

Microbial identification

Antimicrobial Bioassay of Antibiotic

Antimicrobial preservative effectiveness test

Bioburden studies

Environmental monitoring:

Air particulate count

Air micro flora count

Settle plate technique

Swab test

Facility Validation Support:

Cleaning validation

Process water testing

Test validation

Process validation

Instrument calibration

Environmental monitoring

Consulting

Common Tests are done in Rangs pharmaceuticals:

1. 1.

Sterility test

1. 2.

Sterility test for WFI:

2. 3.

Bacterial endotoxin test (LAL test)

3. 4.

Total viable count test

4. 5.

Fungal count

5. 6.

Escherichia coli identification test

6. 7.

Staphylococcas aureus identification test

7. 8.

Salmonella sp.identification test

8. 9.

Pseudomonas aeruginosa identification test

10. Settle plate

11. Air microflora count:
12. Swab test
13. Preservative efficacy test

Machineries:
1. 1.

Bacterial incubator

Memmert
Capacity: 53 liter
Temperature: 30 to 70 C
Origin- Germany
Function- Enhancement of Bacterial growth
1. 2.

Fungal incubator

Memmert
Capacity: 53 liter
Temperature: 30 to 70 C
Origin- Germany
Function- Enhancement of Fungal growth
1. 3.

Incubator

Memmert
Capacity: 53 liter
Temperature: 30 to 70 C
Origin- Germany
Function- Used for particular microbiological test
1. 4.

Speedy Autoclave

High Pressure Steam Sterilizer

Tomen
Temperature: 121 C, Time- 50min
Origin- Taiwan
Function- To sterilize media or materials
1. 5.

Laminar Airflow Cabinet

Airtech Horizontal type

Origin- Singapore
Function- To conduct microbiological in sterile environment

1. 6.

Air Microflora Sampler

Sanitization machine
Sertorius
Model- MD8
Origin- Germany
1. 7.

Air Borne Particle Counter

Climate
Model- CIT
Origin- USA
Function- Counting of different size of particles suspended into clean
room air
1. 8.

Refrigerator

Meiling Stone
Temperature: Below 8 C
Origin- Korea
Function- Preservation of microbial cultured kits
Research & Development Department
Functions of Research and development department:
New product formulation.
Reformulation.
Reprocess.
Trouble shooting.
Preparation of B.P.R. for a new product.
Development of existing product.
Development of a new product
Step-1:
Product information from marketing department along with necessary attributes such as
- Source
- Sample
- Q.C test (potency. LOD etc)
Step-2:
Pre-formulation study of the active drug and excipient.
- Chemical activity.
- Function.
- Interaction.

- Boiling point.
- Contraindication.
- Moisture content etc.
Step-3:
Collection of raw materials of active drug and excipients.
Step-4:
Different trials for development of a stable, effective and active formulation.
Step-5:
Drug administration formalities include:
a) Submission of recipe to drugs administration which contains - strength
- dosage form
- contraindication
- dosage form
- dissolution
- description
- precaution
- side effect
- M.R.P.
- indication
b) Sample admission (if INN product)
c) Approval of sample from drug administration and inclusion of D.A.R. and license
no.
d) Submission of Inclusion Dossier.
e) Final approval for commercial production.
Step-6:
Pilot trial and accelerated stability testing.
Step-7:
Readjustment If necessary.
Step-8:
BMR preparation if every aspect is satisfied which contains
- product name
- code
- size

- batch no
- theoretical yield
- batch size
- annexure etc.
Step-9:
Transfer to commercial production.
Development of existing products
Research and development department also deals with the development of existing product
formulation.
Objective:
a) Increasing the quality of the product.
b) Prevention of any type of problem existing in the product.
c) To save time and cost.
d) Increasing the patient acceptance.
The project file
It contains project related every papers such as

Recipe

Product attributes

Lab tried process records

Stability study protocol and report

Approved product data sheet

Sales forecast

Standard packaging material sample

Process validation protocol record

Related correspondence

WARE HOUSE DEPARTMENT

Involved areas
-

Raw material store

Packaging material store

Finished product store

Conditions maintained in ware house:

For non antibiotic store, normal temperature and storage condition is maintained.

For antibiotic store, 15-18 c and bellow 50% humidity is maintained.

For cool sore, 2-8 c temperature is maintained.

GMP method for Ware house:

FIFO (first in first out) strategy is followed for the release of RM to manufacturing. Although
materials are always taken from the approved source, batch no of the renders, manufacturing
date, expiry date, etc are checked before entry, complete security & prevention of pilferage of
every materials are confirmed.
Activities of Ware house:
1. Initially in the ware house, the quality of the product is not checked.
2. Only physical exam is done, which include whether he container is properly sealed.
3. If he staffs mentioned in the invoice are present or not, if the no. of the container are same or not.
4. If passes kept in quarantine area
5. The invoice date of he received is inputted in SAP
6. From SAP, QC check if every thing is ok and a manual is also sent o QC
7. From sampling booth the sample is sent o QC
8. Sample tag is attached.
9. If the RM complies, approval tag is attached by QC.
10. All the data are uploaded in SAP.
11. From there production we can see and ask according to need.
12. Ware house follows FIFO and doss the dispensing in the dispensing unit

MAINTENANCE
The function of this section is to separate the utilities and services in the plant. This section is
very important for any pharmaceuticals. The utilities and services handled by this section are
given bellow:
1. Electricity
2. Production machineries maintenance
3. Quality control machineries maintenance.
4. Utility services
5. Construction

CONCLUSION:
Industrial plant plays a vital role in any industry. Quality product ensures the companys prospect
in order to create loyalty. Rangs Pharmaceuticals is no longer beyond the objective to provide
quality product for the target customer. In order to gain the multi national infrastructure, Rangs
Pharmaceuticals need to look forward in both in Plant Infrastructure and its proper management.