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Supervised by: Submitted by:
Mr.Ashwin Singh Chouhan prakash chandar
M. Pharm (Pharmacology) B. pharmacy
Assistant Professor Sem. VIIth (2021-22)
Pharmacology Dept. Enroll.No. :
 Introduction
 Vision, Mission
 List of Products
 RMS
 PMS
 Tablets Manufacturing
 Packing Department
 QC- Section
 Conclusion
Location- Amneal pharmaceutical Pvt. Ltd.
Plot No 15, 16, 17 Pharmez
Sarkhej Bavla Highway, Matoda
Ahmedabad – 382213
India.
VISION, MISSION
VISION-Amneal Pharmaceutical is the leading healthcare professionals with a top
ranking position in India and US. Amneal pharmaceuticals are leading manufacturer in
oral solids and injectable.
MISSION- We shall ensure the quality, reliability, and innovation thereby enhancing
the sustainability and values for all stakeholders.
Approved material can transfer can to production department as per demand, rejected
material key given to QA manager.
After test if material is ok then they labeled it as approved. And if not labeled as reject
QC Department take material for sampling to check and test the received material.
And label the containers or tanks as UNDERTEST.
RM incharge do the entry of received material in register. And check the A.R NO.,
BATCH NO., MFG, and EXP. DATE
Frist day I visited RMS Department where all raw material transport form warehouse.
Now this material keeps in quarantine section
Dispensing area, one should wear a clean lint free gown, hand gloves, protect nose by mask
sunglasses and cap.
1. Line clearance
2. Reverse laminar flow for 15 min.
3. Weigh required quantity of material as per batch (MFR)
4. Make label individually
Sterilization-
Sterilization is the process of destruction or elimination of all forms of microorganism by:
Dry Heat
1) Dry heat sterilization is a method of sterilization that uses high temperature under dry condition.
2) Protein denaturation oxidative damage and toxic effect of elevated level of electrolytes.
3) Hot air over
Moist Heat
1) Moist heat sterilization is a method of sterilization that uses high temperature and pressure
generated by water system.
2) Mainly by denaturation and congelation of proteins
3) Autoclave 121°C for 30 min.
Tablet is compressed solid dosage form containing medicament with or without excipient.
As per IP Tablets are solid, flat or biconvex dishes unit dosage forms, prepared by compressing
a drug or a mixture of drug with or without diluents.
Type of Tablet-
Defects in Tablets-
Defects in Tablets-
Coated Uncoated
Sugar
coated
Enteric
dispersible
Chewable
Sustained
release
Effervesce
nt
Sublingual
Capping Chipping Sticking Picking Mottling
Double
impression
Lamination Cracking
Blending:
Blending is a critical part of pharmaceutical manufacturing. It consists of two
parts, the actual mixing of powdered ingredients to a desired degree of
homogeneity and the analytical testing to conform the same.
1. Granulator: the granulator rotates at two steps-
1500/3000RPM. The granulator head is of highly polished
stainless steel and is easily removable for cleaning.
• Capacity: 1000 litter
• Time of Running: 1 hour (approx.)
• Utility: assist blending of powder
and to assist blending of powder and
to break the product to granules of
required size.
The most widely used process of agglomeration in a
pharmaceutical industry is wet granulation. Wet granulation
processes simply involve the wet mass of the powder blend with
a granulating liquid. Wetting size and drying are important steps
in involved in the wet granulation.
Dry granulation is a powder agglomeration process used in the
pharmaceutical industry to improve the flowablity of powders by
increasing the particle size.
The compression stage of the tablet compressing process forms
the tablet. This stage involves bringing together the upper and
lower punches under pressure within the die to form the tablet.
As the punches enter the compressing stage, the upper and
lower punches move between two large wheels called pressure
rolls.
Part of Compression-
 Calibration of Weight Balance
 Disintegration Tester
 Hardness Tester
 Metal Dector
An application of coating material to the exterior of tablets
with intension of conferring benefit and properties to the
dosage form over uncoated variety.
Types of Tablet Coating
 Sugar coating
 Film coating
 Press coating
capsules are solid dosage forms in which one or more
medicinal and/or inert substances are enclosed within a
small shell or container generally prepared from a suitable
form of gelatine. Depending upon their formulation, the
gelatine capsule shells may be hard or soft.
Capsule filling
 Hand filling
 Semi- Automatic
 Automatic
This procedure applies to all bottle packaging and labelling
operations carried out by the packing department, which will
ensure that the processes are carried out systematically in a oral
solid dosage unit.
Procedure-
 Plan the packaging of manufacturing batch based on planning given by
planning department.
 The packaging/PPMC officer/designee shall initiate the BPR REQUISITION
FROM” based upon the packaging schedule and send to QA for issuance BPR.
 Issuance and receipt of packaging and labeling materials.
 Bifurcation of the product (If batch is intended to be packed in more than one
pack style)
 Machine setting in case of product/pack size change.
 Packaging equipment and area clearance.
 Machines set up and startup of packaging line.
 Packaging run and In-process checks.
 Batch completion and Reconciliation.
Bottle
Unscrambler
Slat Counter
Filler
Optel Slat
Inspection
System
Canister Desicant
Inserter
Inline Capper
Check Weigher
Induction
Cap Sealer
Labelling
Machine
Labelling
Inspection
System
Top Out
serter/3D
checking
360 machine AFC Machine
Ibuprofen Tablet
Benazepril Hcl Tablet
Use:-ibuprofen 400mg tablet is a pain-relieving
medicine. It is used to treat many conditions such as
headache, fever, period pain, toothache, colds and
mild arthritis. It is also a common ingredient in
many cold and flu remedies.
Use:-Benazepril is used to treat high blood pressure
(hypertension). Lowering high blood pressure help
prevent strokes, heart attacks, and kidney problems.
Benazepril is an ACE inhibitor and works by
relaxing blood vessels so that can blood can flow
more easily
Folic Acid Tablet
Ezetimibe Tablet
Use:-Folic acid is used to treat or prevent folate
deficiency anaemia. Help your unborn baby’s brain,
skull and spinal cord develop properly to avoid
development problems (called neural tube defects)
such as spina bifida.
Use:-Ezetimibe is a type of medicine used to lower
cholesterol. It’s used to treat high blood cholesterol.
This is when you have too much of fatty substance
called cholesterol in your blood.
Hydroxyl Chloroquine Tablet
Propranolol Hydrochloride Tablet
Use:-Hydroxyl chloroquine tablet is used to
treatment of autoimmune conditions such as
rheumatoid arthritis and systemic lupus
erythematosus. It slows down the progression of the
disease and provides relief from pain, swelling and
redness.
Use: - treat high blood pressure. Treat conditions
that cause an irregular heartbeat like atrial
fibrillation. Help prevent future heart disease, heart
attacks and strokes. Help prevent chest pain caused
by angina.
After, undergoing industrial training at Amneal
Pharmaceutical Ahmedabad. I, came to know about the
dedication and hard work that the employees put in
production department.
I had completely understand the difference between the
practical and theoretical knowledge.
I also got good exposure of industrial environment.
Finally I want to acknowledge my academic guide and MR.
Tushar thakar as they gave me the opportunity to work there.
Amneal Pharmaceuticals Internship Report

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Amneal Pharmaceuticals Internship Report

  • 1.
  • 2. Supervised by: Submitted by: Mr.Ashwin Singh Chouhan prakash chandar M. Pharm (Pharmacology) B. pharmacy Assistant Professor Sem. VIIth (2021-22) Pharmacology Dept. Enroll.No. :
  • 3.  Introduction  Vision, Mission  List of Products  RMS  PMS  Tablets Manufacturing  Packing Department  QC- Section  Conclusion
  • 4. Location- Amneal pharmaceutical Pvt. Ltd. Plot No 15, 16, 17 Pharmez Sarkhej Bavla Highway, Matoda Ahmedabad – 382213 India. VISION, MISSION VISION-Amneal Pharmaceutical is the leading healthcare professionals with a top ranking position in India and US. Amneal pharmaceuticals are leading manufacturer in oral solids and injectable. MISSION- We shall ensure the quality, reliability, and innovation thereby enhancing the sustainability and values for all stakeholders.
  • 5. Approved material can transfer can to production department as per demand, rejected material key given to QA manager. After test if material is ok then they labeled it as approved. And if not labeled as reject QC Department take material for sampling to check and test the received material. And label the containers or tanks as UNDERTEST. RM incharge do the entry of received material in register. And check the A.R NO., BATCH NO., MFG, and EXP. DATE Frist day I visited RMS Department where all raw material transport form warehouse. Now this material keeps in quarantine section
  • 6. Dispensing area, one should wear a clean lint free gown, hand gloves, protect nose by mask sunglasses and cap. 1. Line clearance 2. Reverse laminar flow for 15 min. 3. Weigh required quantity of material as per batch (MFR) 4. Make label individually Sterilization- Sterilization is the process of destruction or elimination of all forms of microorganism by: Dry Heat 1) Dry heat sterilization is a method of sterilization that uses high temperature under dry condition. 2) Protein denaturation oxidative damage and toxic effect of elevated level of electrolytes. 3) Hot air over Moist Heat 1) Moist heat sterilization is a method of sterilization that uses high temperature and pressure generated by water system. 2) Mainly by denaturation and congelation of proteins 3) Autoclave 121°C for 30 min.
  • 7. Tablet is compressed solid dosage form containing medicament with or without excipient. As per IP Tablets are solid, flat or biconvex dishes unit dosage forms, prepared by compressing a drug or a mixture of drug with or without diluents. Type of Tablet- Defects in Tablets- Defects in Tablets- Coated Uncoated Sugar coated Enteric dispersible Chewable Sustained release Effervesce nt Sublingual Capping Chipping Sticking Picking Mottling Double impression Lamination Cracking
  • 8. Blending: Blending is a critical part of pharmaceutical manufacturing. It consists of two parts, the actual mixing of powdered ingredients to a desired degree of homogeneity and the analytical testing to conform the same.
  • 9. 1. Granulator: the granulator rotates at two steps- 1500/3000RPM. The granulator head is of highly polished stainless steel and is easily removable for cleaning. • Capacity: 1000 litter • Time of Running: 1 hour (approx.) • Utility: assist blending of powder and to assist blending of powder and to break the product to granules of required size.
  • 10. The most widely used process of agglomeration in a pharmaceutical industry is wet granulation. Wet granulation processes simply involve the wet mass of the powder blend with a granulating liquid. Wetting size and drying are important steps in involved in the wet granulation.
  • 11. Dry granulation is a powder agglomeration process used in the pharmaceutical industry to improve the flowablity of powders by increasing the particle size.
  • 12. The compression stage of the tablet compressing process forms the tablet. This stage involves bringing together the upper and lower punches under pressure within the die to form the tablet. As the punches enter the compressing stage, the upper and lower punches move between two large wheels called pressure rolls. Part of Compression-  Calibration of Weight Balance  Disintegration Tester  Hardness Tester  Metal Dector
  • 13. An application of coating material to the exterior of tablets with intension of conferring benefit and properties to the dosage form over uncoated variety. Types of Tablet Coating  Sugar coating  Film coating  Press coating
  • 14. capsules are solid dosage forms in which one or more medicinal and/or inert substances are enclosed within a small shell or container generally prepared from a suitable form of gelatine. Depending upon their formulation, the gelatine capsule shells may be hard or soft. Capsule filling  Hand filling  Semi- Automatic  Automatic
  • 15. This procedure applies to all bottle packaging and labelling operations carried out by the packing department, which will ensure that the processes are carried out systematically in a oral solid dosage unit. Procedure-  Plan the packaging of manufacturing batch based on planning given by planning department.  The packaging/PPMC officer/designee shall initiate the BPR REQUISITION FROM” based upon the packaging schedule and send to QA for issuance BPR.  Issuance and receipt of packaging and labeling materials.  Bifurcation of the product (If batch is intended to be packed in more than one pack style)  Machine setting in case of product/pack size change.  Packaging equipment and area clearance.  Machines set up and startup of packaging line.  Packaging run and In-process checks.  Batch completion and Reconciliation.
  • 16. Bottle Unscrambler Slat Counter Filler Optel Slat Inspection System Canister Desicant Inserter Inline Capper Check Weigher Induction Cap Sealer Labelling Machine Labelling Inspection System Top Out serter/3D checking 360 machine AFC Machine
  • 17. Ibuprofen Tablet Benazepril Hcl Tablet Use:-ibuprofen 400mg tablet is a pain-relieving medicine. It is used to treat many conditions such as headache, fever, period pain, toothache, colds and mild arthritis. It is also a common ingredient in many cold and flu remedies. Use:-Benazepril is used to treat high blood pressure (hypertension). Lowering high blood pressure help prevent strokes, heart attacks, and kidney problems. Benazepril is an ACE inhibitor and works by relaxing blood vessels so that can blood can flow more easily
  • 18. Folic Acid Tablet Ezetimibe Tablet Use:-Folic acid is used to treat or prevent folate deficiency anaemia. Help your unborn baby’s brain, skull and spinal cord develop properly to avoid development problems (called neural tube defects) such as spina bifida. Use:-Ezetimibe is a type of medicine used to lower cholesterol. It’s used to treat high blood cholesterol. This is when you have too much of fatty substance called cholesterol in your blood.
  • 19. Hydroxyl Chloroquine Tablet Propranolol Hydrochloride Tablet Use:-Hydroxyl chloroquine tablet is used to treatment of autoimmune conditions such as rheumatoid arthritis and systemic lupus erythematosus. It slows down the progression of the disease and provides relief from pain, swelling and redness. Use: - treat high blood pressure. Treat conditions that cause an irregular heartbeat like atrial fibrillation. Help prevent future heart disease, heart attacks and strokes. Help prevent chest pain caused by angina.
  • 20. After, undergoing industrial training at Amneal Pharmaceutical Ahmedabad. I, came to know about the dedication and hard work that the employees put in production department. I had completely understand the difference between the practical and theoretical knowledge. I also got good exposure of industrial environment. Finally I want to acknowledge my academic guide and MR. Tushar thakar as they gave me the opportunity to work there.