TRAINING REPORT AT AMOL PHARMACEUTICALS PRIVATE LIMITED, JAIPUR.

Submitted by Akash kumawat

B.PHARM. (FINAL YEAR) (2009-2010) VIDYASTHALI INSTITUTE OF TECHNOLOGY, SCIENCE AND MANAGEMENT Prithviraj Nagar, Maharani Farm, Durgapura, Jaipur AFFILIATED TO RAJASTHAN UNIVERSITY OF HEALTH SCIENCES JAIPUR.

TRAINING REPORT
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AMOL PHARMACEUTICALS PRIVATE LIMITED, JAIPUR.

On the job training report submitted to VIDYASTHALI INSTITUTE OF TECHNOLOGY, SCIENCE AND MANAGEMENT ,JAIPUR, in the partial fulfillment of the requirement of the RAJASTHAN UNIVERSITY OF HEALTH SCIENCES, JAIPUR, for the award of the Degree of Bachelor of Pharmacy. Training date: 01/08/2009 to 30/9/2009 SUBMITTED BY

Akash kumawat
B.PHARM. (FINAL YEAR) (2009-2010)

VIDYASTHALI INSTITUTE OF TECHNOLOGY, SCIENCE AND MANAGEMENT Prithviraj Nagar, Maharani Farm, Durgapura, Jaipur AFFILIATED TO RAJASTHAN UNIVERSITY OF HEALTH SCIENCES JAIPUR.

CERTIFICATE

This is to certify that Mr. Akash kumawat of B.Pharm part-IV (2009-2010) has undergone a 400 hours practical training at Amol Pharmaceuticals Private Limited E1 - 363, Siatpura Industrial Area, Sitapura, Jaipur -302022 - Rajasthan ,INDIA. This on the job training report submitted by him in partial fulfillment of requirement for the award of the Degree of Bachelor of Pharmacy is a bonafide work of his own, carried out at allotted training centre, from 01/08/2009 to 30/9/2009. Date:

PRINCIPAL
Vidyasthali institute of Technology, Science & Management,
Jaipur (Raj.)

ACKNOWLEDGEMENTS
I want to thanks all members of Amol Pharmaceuticals Pvt. Ltd. to support me to get acquire more knowledge about all matter during training periods.
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I express my sincere thanks to Mr J.C. Indolia, Asstt.Vice President-HRD & Admn. of Amol Pharmaceuticals Pvt. Ltd. for his generous co-operation, allowing us to learn at the site and for his blessings.

I feel privileged to express my thanks to Mr.Yogendra choudhary (Q.A. Manager), Mr.Durga singh (Senior Chemist) and Mr.Vipin mishra (Q.C. Manager) for their kind co-operation by him time to time & to create family environment in industry.

I express my deep appreciation & thanks to all workers of Amol Pharmaceuticals Pvt. Ltd, my friends and college for their cooperation to learn in the industry.

I am very thankful to my respected sir Mr. Pankaj sharma (Principal of Vidyasthali Institute of Technology Science & Management) for the great support in my training.

Last but not the least I owe a special debt of gratitude to my family and my brother VIKAS for the great support in my training.

CONTENTS/INDEX S.No. 1. TITLE GENERAL INFORMATION PAGE NO. 6

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2. 3. 4. 5. 6. 7.

PERSONNEL PRODUCTS LIST OF MACHINERY PREMISES CONTRUCTIONAL REQUIREMENTS QUALITY MANAGEMENT SUMMARY

9 12 23 27 29 31 37

1. GENERAL INFORMATION

Amol Pharmaceuticals Pvt. Ltd. (APPL) is a leading manufacturer of pharmaceuticals, herbals, minerals, vitamins, amino acids, specialty dietary supplements in the form of finished formulations. Established as an India based manufacturer of pharmaceutical & nutraceutical products, APPL & its group companies have grown to operate
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manufacturing facilities in the US, India & China and maintain two global sourcing offices, and an independent customer support & sales office for its US & world based clientele. This group has marched its way and has pedestalled its position as a leading manufacturer and exporter of Authentic Prodigious Pharmaceuticals and Neutraceuticals on Land. Its business model is to develop and supply customer specific pharmaceutical, herbal & nutraceutical products with an emphasis on quality control and customer service. Its global team is comprised of over 200 Manufacturing and quality control personnel who have been successfully fulfilling the demands of a discerning market for over a decade. Currently its portfolio of product stretches well beyond 200 finished products, all manufactured in state of the art GMP certified production facilities ISO 9001-2000. Its principal administration and distribution facilities are based in the US, India & China with our Research & Development team imbedded across its three manufacturing units. APPL's commitment to growing with its customers is clear. For your pharmaceutical, herbal and nutraceutical needs, come see how you can benefit from being Naturally based Globally Placed

Name and exact address of the site:

AMOL PHARMACEUTICALS PRIVATE LIMITED,
E1 - 363, Sitapura Industrial Area,

Sitapura, Jaipur - Rajasthan , INDIA 302022.

Contact person: Telephone nos.:

91-0141-2771132,

91-0141- 2771150. Fax : 0141 2770744.

Website:

http://amolpharmaceuticals.com

2. PERSONNEL

QUALITY ASSURANCE MANAGER

Production manager

Q.C.Incharge

Commercial and Admininistration

Assistant Manufacturing Chemist

Personnel Details:-

S.no. 1. 2. 3. 4. 5. 6. 7. 8.

Name Mr. Sandeep sapra Mr. Girish maheshwari Mr. J.C.Indolia Mr. Yogendra choudhary Mr. Durga Singh Mr. Vipin mishra Mr. Kalyan sahai saini Mr. Mahendra singh

Post M.D. Manager Asstt.vice President-HRD & Admn Q.A. manager Senior Chemist Q.C. manager Head of manufacturing Plant H.R.

Total Number of employees is more than 50.

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Q.A. Manager

Production manager

Q.C.Incharge

Store and Ditribution Incharge Marketing manager

Assistant Chemist

Senior Chemist

Store Keeper

Area

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3.PRODUCTS

(A) Harbal Products:Harbal-Formulation

Name Usage
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Ameravite Power Gold Power & Stamina Ameravite Energiser Ameravite Power Silver Stronger and Sustained Stamina and Vitality Power & Stamina To get rid of piles Reduces Excessive Fat GIT System Disease

Ameravite Pilexo Ameravite Fitmax Ameravite Gastroaid

Ameravite Vigor Gold Power & Stamina Ameravite Urinaid Ameravite Osteoforte Ameravite Diaborid Ameravite Mensuraid Ameravite Diabacure Plus Burning Micturition, Urinary tract Infection, Poor renal function & Crystalluria Osteoarthritis, Cervical and lumbar spondylosis Anti-Diabetic Mensuration Anti-Diabetic Stone Power & Stamina Memory Improvement Protects the liver against various hepatotoxins Improve Immunity System Blood Purifier

Ameravite Stonil Ameravite Vigor Plus Ameravite Memory Plus

Ameravite Livage Ameravite Imunoaid Ameravite Pured

Ameravite pilexo Plus Anti piles Ameravite Mensuraid Plus Mensuration Reduces the cholesterol and Triglyceride levels
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Ameravite Slimfit

Ameravite Vigor Ameravite Diabacure Ameravite Joint Flex Ameravite Hairin Ameravite Digesto Ameravite Sofex Ameravite Ulcex Ameravite Diaborid Ameravite Relax Ameravite Amebex Ameravite Flexaid Ameravite Gasorid Ameravite Locid Ameravite Energy

Power & Stamina Anti-Diabetic Joint Pain Hair fall and anti dandruff Digestion & Gastric Gas and indigestion Anti-Ulcer Anti-Diabetic Relieves Constipation Amoebiasis Relieves Constipation Anti-Gastric Anti-Acid Power & Stamina

Herbal-Raw material
Andographis Paniculata Extract Ashwagandha Extract Asparagus Racemosus Extract (Neem) Gymnema Sylvestre Extract Mamordica Charantia Extract Oregano Extract
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 Azadirachita Extract Bacoppa Monnieri Extract Black Pepper Extract Boswellia Serrata Extract Natural Caffeine Capsaicin Extract Centella Asiatica Extract Cinnamon Bark Extract Curcumin Extract Emblica Offcinalis Extract (Amla) Green Tea Extract Garcinia Cambogia Extract Zingiber officinalis Extract Gingko Biolba Extract Grape Seed Extract Grape Skin Extract Commiphora Mukul Extract

Picrorhiza Root Extract Piper Longum Extract Quercetin Extract Rhodiola Rosea Extract Sage Extract Salacia Oblonga Extract White Willow Bark Extract Senna Pod Granules Shilajit Extract Sida Cardifolia Extract Soy Isoflavones Extract Milk Thistle Extract Trigonella Foenum Extract Tribulus Terrestris Extract Triphala Extract Tulsi Extract Valerian Officinalis Extract

(B) Minerals :-

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 Centravit Min 99 Each 20mg Contains Chromium (Chromium Chloride) 120mcg

Selenium (Sodium Selenate) - 20mcg Molybdenum (Sodium Molybdate) 75mcg Vanadium (Sodium Metavanadate) 10mcg Silicon (Silicon Dioxide/Sodium metasilicate) - 10mcg Centravit Select Min 99 Each 20mg Contains

Tin (Stannous Chloride) - 10mcg Nickel (Nickel Sulfate) - 5mcg Boron (Sodium Borate) 150mcg Selenium (Sodium Selenate) - 20mcg Molybdenum (Sodium Molybdate) 75mcg Silicon (Silicon Dioxide/Sodium Metasilicate) - 10mcg Centrit 8 Performance Each 20mg Contains Chromium (Chromium Chloride) 50mcg Vanadium (Sodium Metavanadate) 10mcg Silicon (Silicon Dioxide/ Sodium Metasilicate) - 10mcg

Chromium (Chromium Chloride) - 50mcg Vanadium (Sodium Metavanadate) 5mcg

Boron (Sodium Borate) - 150mcg Selenium (Sodium Selenate) - 20mcg Molybdenum (Sodium Molybdate) 75mcg

Nickel (Nickel Sulfate) - 5mcg Boron (Sodium Borate) - 150mcg Iron (Ferrous Fumarate) - 18mg Selenium (Sodium Selenate) - 20mcg Manganese (Manganese Sulfate) 2mg Molybdenum (Sodium Molybdate) 75mcg

Regular Min Each 265 mg Contains Iodine (Potassium Iodide) - 150mcg Copper (cupric Oxide) - 2mg Chromium (Chromium Chlorate) 120mcg

Potassium (Potassium Chloride) - 80mg Chloride (Potassium Chloride) - 72mg Tin (Stannous Chloride) - 10mcg Vanadium (Sodium Metavanadate) 10mcg
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 Nickel (Nickel Sulfate) 5mcg Zinc (Zinc Oxide) - 15mg Boron 1% MinTriT (Boron Granules) Chromium 1% Min TriT (Chromium Granules)

Silicon (Silicon Dioxide/Sodium Metasilicate) - 10mcg

Boron - 150mcg Boron 5% Min TriT (Boron Strong Granules) Chromium 2% MinTriT (Chromium-S Granules)

Chromium Picolinate 1% MinTriT (Chromium Regular Granules) Iodine 5% MinTriT (Potassium Iodide Granules) Molybdenum 1% MinTriT (Molybdenum Granules)

Chromium Picolinate 2% MinTriT (Chromium Maximum Granules) Iodine 20% MinTriT (Iodine S-Granules) Molybdenum 2% MinTriT (Molybdenum-S Granules) Selenium 1% MinTriT (Selenium Granules) Tin 1% MinTrit (Stannous Chloride Granules)

Nickel 1% MinTriT (Nickel Granules) Selenium 2% MinTriT (Selenium-S Granules) Vanadium 0.5% MinTriT (Vanadium Granules)

(C) Amino acid :-

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 Centravit Min 99 Each 20mg Contains Chromium (Chromium Chloride) 120mcg

Selenium (Sodium Selenate) - 20mcg Molybdenum (Sodium Molybdate) 75mcg Vanadium (Sodium Metavanadate) 10mcg Silicon (Silicon Dioxide/Sodium metasilicate) - 10mcg Centravit Select Min 99 Each 20mg Contains

Tin (Stannous Chloride) - 10mcg Nickel (Nickel Sulfate) - 5mcg Boron (Sodium Borate) 150mcg Selenium (Sodium Selenate) - 20mcg Molybdenum (Sodium Molybdate) 75mcg Silicon (Silicon Dioxide/Sodium Metasilicate) - 10mcg Centrit 8 Performance Each 20mg Contains Chromium (Chromium Chloride) 50mcg Vanadium (Sodium Metavanadate) 10mcg Silicon (Silicon Dioxide/ Sodium Metasilicate) - 10mcg

Chromium (Chromium Chloride) - 50mcg Vanadium (Sodium Metavanadate) 5mcg

Boron (Sodium Borate) - 150mcg Selenium (Sodium Selenate) - 20mcg Molybdenum (Sodium Molybdate) 75mcg

Nickel (Nickel Sulfate) - 5mcg Boron (Sodium Borate) - 150mcg Iron (Ferrous Fumarate) - 18mg Selenium (Sodium Selenate) - 20mcg Manganese (Manganese Sulfate) 2mg Molybdenum (Sodium Molybdate) 75mcg

Regular Min Each 265 mg Contains Iodine (Potassium Iodide) - 150mcg Copper (cupric Oxide) - 2mg Chromium (Chromium Chlorate) 120mcg

Potassium (Potassium Chloride) - 80mg Chloride (Potassium Chloride) - 72mg Tin (Stannous Chloride) - 10mcg Vanadium (Sodium Metavanadate) 10mcg
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 Nickel (Nickel Sulfate) 5mcg Zinc (Zinc Oxide) - 15mg Boron 1% MinTriT (Boron Granules) Chromium 1% Min TriT (Chromium Granules)

Silicon (Silicon Dioxide/Sodium Metasilicate) - 10mcg

Boron - 150mcg Boron 5% Min TriT (Boron Strong Granules) Chromium 2% MinTriT (Chromium-S Granules)

Chromium Picolinate 1% MinTriT (Chromium Regular Granules) Iodine 5% MinTriT (Potassium Iodide Granules) Molybdenum 1% MinTriT (Molybdenum Granules)

Chromium Picolinate 2% MinTriT (Chromium Maximum Granules) Iodine 20% MinTriT (Iodine S-Granules) Molybdenum 2% MinTriT (Molybdenum-S Granules) Selenium 1% MinTriT (Selenium Granules) Tin 1% MinTrit (Stannous Chloride Granules)

Nickel 1% MinTriT (Nickel Granules) Selenium 2% MinTriT (Selenium-S Granules) Vanadium 0.5% MinTriT (Vanadium Granules)

(D) Tablet and capsules :1) Fitavit-natural fitness capsules

Each capsule containsExtracts derived from19

Withnia somnifera-760mg Emblica officinalis-360mg Asparagus racemasus-200mg Tinospora cordifolia-140mg Tribubu terrestris-100mg Picrorhiza kurroa-40mg Cyperus scariosus-60mg Terminalia chebula-80mg Piper longum-100mg Myristica fragrans-40mg Excipients- q.s.

2) Aceclofenac & Paracetamol tablets Dalarest-p

Each tablet contains Aceclofenac IP100mg Paracetamol IP.500mg Colour-Titanium dioxide IP

3) Ornidazoles & ofloxacin tablets Oflabact-02

Each tablet contains Ornidazole500mg
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Oflaxacin..200mg Colour-sunset yellow FCF &Titanium dioxide IP

4) Omeprazole capsules IP Omital-20

Each capsule containsOmeprazole IP..20mg Colour-Approved colour used in the capsule shell.

5) Ibuprofen & Paracetamol tablets

Each tablet contains Ibuprofen.400mg Paracetamol.325mg

6) Azithromycin tablets IP AZIMOL -250

Each film coated tablet contains Azithromycin Dihydrate IP Eq. to Azithromycin (anhydrous) 250mg Colour :yellow Oxide of iron

(D) Speciality in production of-

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 Ascorbyl Palmitate Granular Choline Bitartrate Granular Chondroitin Sulfate Powder Chromium Picolinate 1% Glucosamine Hydrochloride Granular Glucosamine Sulfate Granular Vitamin B 12 - 1% Vitamin K 1 - 1% Folic Acid 10% Alpha Lipoic Acid Powder Methyl Sulfonyl Methane

Ascorbyl Palmitate Powder Chondroitin Sulfate Granular Chromium Picolinate Pure Chromium Picolinate 2% Glucosamine Hydrochloride Powder Glucosamine Sulfate Powder Vitamin B 12 - 10% Vitamin K 1 - 5% Alpha Lipoic Acid Granular Biotin 1% Chondroitin Sulfate & Glucosamine granules

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4. LIST OF MACHINARY

There are separate machinery for each section

(A)

Instrument section :-

Inductively Coupled Plasma Spectrometer (ICP) Gas Chromatography with Headspace (GC)
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 High Performance Liquid Chromatograph with UV Detector (HPLC) Atomic Absorption Spectrophotometer (AAS) UV-Visible Spectrophotometer (UV & Vis) Furior Transform Infrared Spectrophotometer (FTIR) Automatic Potentiometric Titrator Polarimeter Spectrofluorophotometer Tablet Disintegration Machine Flame Photometer ABBE Refractrometer Tablet Hardness Tester Tablet Dissolution Tester Melting Point Apparatus Friability Test Apparatus Karl Fischer Apparatus

(B) General section : Environmental Chambers TLC Chamber

UV Cabinet Rotatory Evaporator (with short and long wavelength UV Tube) Mettler Balance Conductivity Meter
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 pH Meter Hot Air Ovens Bulk Density Apparatus Buchi Bath Hot Plates Viscometer Vacuum Oven Flask Shaker Lab Stirrer IR moisture Balance Fuming Chamber Micrometer Leak Test Apparatus

Muffle Furnaces Sieve Shaker Ultrasonic Bath Water Bath Heating Mantle Distillation Unit Magnetic Stirrer Monopan Balance Vernier Calipers Vacuum Desiccator Centrifuge machine Cobbmti Tester

(C) Microbiological section :-

Ultra Deep Freezer Laminar air flow bench (L A F) BOD Incubators (Double Walled)

Autoclave/Sterilizer Electronic Colony counter Simple Incubator

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 Refrigerator Top loading Balance Hot Air Ovens Hot Plates Heating Mantle Anaerobic Jar Vortex shaker (Test tube)

Microscopes pH Meter Water Bath Centrifuge Gas Burner and cylinder LAL test kit Accu-jet (pipet controller)

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5. PREMISES

Factory is constructed in two building; first is administartive section and second is for analytical purpose. The raw material stores are separate and their entries are also separate.

Distribution
1) Raw material store General 2) Raw material store for tablet

3) Raw material store for capsule

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4) General Capsule section

5) Ancillary area for General Capsule 6) Change room (Gents) 7) Change room (Ladies)

8) Office room
9) Laboratory Instrument room 10) Laboratory Chemical room 11) Finished goods store 12) Return goods store 13) Washing, Drying room 14) Pkg. room 15) Stripping room and pkg. cap. 16) Primary pkg. material store 17) Secondary pkg. material store

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6. CONSTRUCTIONAL REQUIREMENTS

Materials used in the construction are cement, bajri and bricks; whereas outer walls are build of stones. The window and door are made up of aluminum and provided glass panels. The floor is made up of kota-stone. The complete building is painted by matt finish washable paint. The corners of roof, walls and floor are coved. The windows are provided fixed glass panels fitted with aluminum frame to stop the direct air. The firm has also provided air handling system in liquid section with prefilter 20 micron and 5 micron primary filter.

There are enough measurements for the control of rodents, pest and insects.
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Insectoquitor is provided in production area. Insecticides and pesticides are used daily to control them. Rodent control must be done once in a year and record is maintained.

7.
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QUALITY MANAGEMENT

1) Quality The end product is prepared as per the official books and as per in house specifications. The firm prepare product as per organoleptic properties for patients acceptance. The firm also fulfills packing requirements for safety and product acceptance, keeping trade requirements to make it profitable for all.

2) Quality policy

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There is a Q.A. manager in the firm who assign each and every work to responsible person. 3) Quality management :Q.A. manager of the firm is responsible for quality management. Q.A. manager has appointed Q.C. Incharge and Assistant Chemist that are responsible for testing and in process control. Q.A. manager has appointed Manufacturing Chemist and Assistant Chemist that are responsible for manufacturing quality. All the S.O.P. is prepared by Q.A. manager of the firm. The quality management system can be renewed after suggestion of any worker or staff.
a. Each and every steps of manufacturing is documented and signed by

authorized person.
b. Specification of material is documented. c. Method of manufacture and control is documented. d. Every product has master formula record. e. S.O.P. has been prepared to ensure the quality management system.

Following equipments are there in the firm for quality management :S.NO 1. Equipment High Performance Liquid Chromatograph, UV Detector
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Solvent delivery module Data processor/ win chrome Ex Software, HP Desk Jet printer. Column oven 2.. Gas Chromatograph with recorder And FID, TCD detectors win Chrome Ex software, HP Desk Jet Printer. 3. UV Visible Spectrophotometer (double beam) microprocessor Controlled recording type with CRT display 4. Fourier Transform Infra Red Spectrophotometer with software (Syncmaster 256 MB) and laser jet Printer 5. 6. Hydraulic press, KBr die Dissolution rate test apparatus 6 Paddles/basket 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Disintegration time test apparatus Laminar air flow work station Electronic balance, top loading Single pan balance Karl Fischer titrator/potentiometer Flame photometer with Na, K, Ca, Li filters Photofluorometer pH meter Polarimeter Refractometer, Abbe
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17.

U.V viewing cabinet Shortwave, longwave radition

18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42.

Thin layer chromatography assembly Microscope Sterility testing unit Digital pyrometer Antibiotiz zone projector Colony counter Melting point test apparatus BOD incubator Incubator Hot air oven Vacuun oven Muffle furnace with pyrometer and terperature regulator, temp, upto 1200 degree C Electric Bunsen, temp, upto 950 degree C Water bath, thermostatically controlled Magnetic stirrer cum hot plate Heating mantel Hot plate Heating block (dry bath) Platinum crucible Oxygen combustion flask Laboratory centrifuge Ultrasonic cleaner Autoclave Vacuum pump Vernier capiler
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43. 44. 45. 46. 47. 48. 49. 50. 51. 52. 53. 54.

Screw gauge Thickness guage Cycio mixer Rotary shaker Tachometer Double distillation apparatus Refrigeator Air conditioner Dehumidifier Peristaltic pump Humidity control oven pump

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SUMMARY

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Amol Pharmaceuticals Private Limited is a dedicated manufacturing unit for the production of pharmaceuticals, herbals, minerals, vitamins, amino acids, specialty dietary supplements in the form of finished formulations. There is an in process control laboratory located in the production block. It is licensed to manufacture, store and distribute for sale of different formulations of pharmaceuticals, herbals, minerals, vitamins, amino acids, specialty dietary supplements. There are present air curtains to avoid the insect & mosquitoes and also double door for positive pressure. The firm has Manager (Mr.Girish maheshwari) , senior manufacturing chemist There are many skilled workers. There are various ranges of products in the factory whose description is given above. There are various ranges of machinery according to the various ranges of products in the factory. Both the raw material stores for tablet and capsule manufacturing are separate and their entries are also separate. The window and door are made up of aluminum and provided glass panels. The floor is made up of kota-stone. The firm prepare product as per organoleptic properties for patients acceptance. Q.A. manager of the firm is responsible for quality management. There is a Q.A. manager in the firm who assign each and every work to responsible person.
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(Mr.

Durga singh), Q.C. Manager (Vipin mishra), Q.A. Manager (Yogendra choudhary) .