in plant training report at rangs pharmaceuticals ltd

8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd

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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 manufactur ing:

Granulation

Compression

Coating

Tablet manu facturin g area:

a. Dispensing area

b. Granulation area

c. Blending area

d. Compression area

e. Coating area

Dispensing Area:


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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:

Granulat ion:

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 granulat ion:

1) Wet granulation

2) Dry granulation

3) Direct compression

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

Purpose for granulat ion:

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 w et granulat ion

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


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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

MARKModel-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 comp ression:

TemperatureRelative humidity

Compression Machine:

200GMP-SQUARE MODEL

Model-CPM D3

Capacity-130000

Running capacity-50000

Clit

Origin-Germany200GMP SQUARE MODEL

Model-CPM B3B

Capacity-130000

Running capacity-78000

Clit


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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 Fi lm coating:-

Solvent

- Organic

- Aquous

Polymer

Plasticizer

Optional ingredients

Anti-foam agent

Colorant

Weight gain for d i f ferent 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 machineModel-FC-39

Capacity-120 kg

Origin-England

Tablet Preparations in Rangs Pharmaceutical-

Brand Name Generic name


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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


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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 5Phosphate 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



Redema 20 Tablet Spironolactone

Furosemide

Redema 40 Tablet Spironolactone

Furosemide

Sartec Tablet Cetirizine DiHydrochloride

Sedaquil 7.5 Tablet Midazalam Maleate

Vesocal-5 Tablet Amlodipine Besylate

Vesocal-10 Tablet Amlodipine Besylate


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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


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Calcium Pantothenate (Pantothenic Acid)

Calcium Carbonate Heavy USP

Dried Ferrous Sulphate (Iron)

DiCalcium 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 DEPARTMENTENCAPSULATION

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.


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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 250, 500mgCuracid 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


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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


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 encapsulat ion:

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


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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. E-Solution preparation

2. II. 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 solut ionis prepared by fol lowing p rocess:

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 fol lowing:

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


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Transfer filled capsule to the bend sealing area pass through the automatic bend sealing

machine


Packaging

Problem may arise during E-Gold manufactur ing:

Bubble Formation

Banana Effect

Machine

1. 1. Automatic Capsule Filling Machine

P+am

Model- LF-40

Capacity- 40000/hr

Origin- India1. 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


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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-VHoonga-A-Corporation

Origin- Korea

1. 3. Topical Blister Packager

Model- DPR-250

RUIAN JIANGHUA MACHINERY.CO. Ltd


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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


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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 ing redients 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


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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 Preparat ion :

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


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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 Parenteralproducts 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 are-

Air Classifications

Clean Area

Classification

(0.5 um

particles/ft3)

ISO

Designationb

> m

particles/m0.53

Microbiological

Active Air

Action

Levelsc(cfu/m

3)

Microbiologica

Settling Plates

Action

Levelsc,d

(diam

90mm; cfu/4

hours)

100 5 3,520 1e 1e

1000 6 35,200 7 3

10,000 7 352,000 10 5

100,000 8 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


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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 theair 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.


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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:

1stchange room

2ndwashing room

Final dressing room

Air shower

Material washing area

Liquid processing unit Ampoule filling & sealing unit

Air lock pass box

Terminal sterilization

Process maintained in sterile product manufacturing unit:

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

Dry heat sterilization


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Moist heat sterilization

Bun washing machine

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

In moist heat sterilization, 121o 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 25o 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 Pack size

Lindex- 1g 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.


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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.


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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


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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)


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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


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6. 7. Staphylococcasaureusidentification test

7. 8. Salmonella sp.identification test

8. 9. Pseudomonasaeruginosa 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 growth1. 2. Fungal incubator

Memmert

Capacity: 53 liter


Origin- Germany

Function- Enhancement of Fungal growth

1. 3. Incubator

Memmert

Capacity: 53 liter


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


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1. 6. Air Microflora Sampler

Sanitization machine

Sertorius

Model- MD8

Origin- Germany1. 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.


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- 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 administrat ion form al it ies 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


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- 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, 15-18oc and bellow 50% humidity is maintained.

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

GMP method for Ware house:


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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.

in plant training report at rangs pharmaceuticals ltd

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