View
283
Download
5
Category
Preview:
Citation preview
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
1/29
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:
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
2/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
3/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
4/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
5/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
6/29
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
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 DiHydrochloride
Sedaquil 7.5 Tablet Midazalam Maleate
Vesocal-5 Tablet Amlodipine Besylate
Vesocal-10 Tablet Amlodipine Besylate
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
7/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
8/29
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.
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
9/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
10/29
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 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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
11/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
12/29
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 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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
13/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
14/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
15/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
16/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
17/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
18/29
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.
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
19/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
20/29
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.
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
21/29
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.
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
22/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
23/29
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)
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
24/29
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
25/29
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
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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
26/29
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.
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
27/29
- 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
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
28/29
- 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:
8/10/2019 In Plant Training Report at Rangs Pharmaceuticals Ltd
29/29
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.
Recommended