You are on page 1of 37

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
1

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

2

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.
3

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
4

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

PERSONNEL PRODUCTS LIST OF MACHINERY PREMISES CONTRUCTIONAL REQUIREMENTS QUALITY MANAGEMENT SUMMARY

9 12 23 27 29 31 37

5

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
6

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,

7

Sitapura, Jaipur - Rajasthan , INDIA 302022.

Contact person: Telephone nos.:
91-0141-2771132,

91-0141- 2771150. Fax : 0141 – 2770744.

Website:

http://amolpharmaceuticals.com

8

2. PERSONNEL

9

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.

10

Q.A. Manager

Production manager

Q.C.Incharge

Store and Ditribution Incharge Marketing manager

Assistant Chemist

Senior Chemist

Store Keeper

Area

11

3.PRODUCTS

(A) Harbal – Products:Harbal-Formulation
Name Usage
12

«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
13

«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
14

« 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 :-

15

« 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
16

« 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 :-

17

« 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
18

« 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 IP………100mg Paracetamol IP……….500mg Colour-Titanium dioxide IP

3) Ornidazoles & ofloxacin tablets Oflabact-02
Each tablet contains Ornidazole………500mg
20

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-

21

« 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

22

4. LIST OF MACHINARY

There are separate machinery for each section
(A)

Instrument section :-

« Inductively Coupled Plasma Spectrometer (ICP) « Gas Chromatography with Headspace (GC)
23

« 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
24

« 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
25

« 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)

26

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
27

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

28

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.
29

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.
30

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 patient’s acceptance. The firm also fulfills packing requirements for safety and product acceptance, keeping trade requirements to make it profitable for all.

2) Quality policy

31

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
32

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
33

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
34

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

35

SUMMARY

36

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 patient’s 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.
37

(Mr.

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