industrial training 02

T.I.T COLLEGE OF PHARMACY

T.I.T COLLEGE OF PHARMACY ANAND NAGAR, BHOPAL

2009-2010

INDUSTRIAL TRAINING REPORT ON

SCHON PHARMACEUTICALS Ltd. INDORE ( M.P )

SUBMITTED BY SUBMITTED TO WASIM AHAMAD DR.B.K.DUBEY 0150PY061057 M.PHARMA, Ph.D


T.I.T COLLEGE OF PHARMACY ANAND NAGAR, BHOPAL (Approved by AICTE , New Delhi and recognized by Govt. of

Madhya Pradesh affiliated to RGPV Bhopal)

CERTIFICATE

This is to certify that Mr.Wasim ahamad

Enrollment No.0150py061057 a student of B.Pharma

Forth year has satisfactorily submitted Report on

“INDUSTRIAL TRAINING”.

DR.B.K.DUBEY (DIRECTOR)


T.I.T COLLEGE OF PHARMACY ANAND NAGAR, BHOPAL

(Approved by AICTE , New Delhi and recognized by Govt. of

Madhya Pradesh affiliated to RGPV Bhopal)

FORWARDING LETTER

Mr.Wasim ahamad has completed His Industrial Training

Report in “SCHON Formulation Pvt. Ltd. INDORE (M.P.)

”in partial fulfillment for the degree of Bachelor of Pharmacy.

The Report is forwarded to the examiner for evaluation.

Date: DR.B.K.DUBEY

Place:BHOPAL Director


INTRODUCTION WHEN BUSINESS IS GOOD IT PAYS TO ADVERTISE WHEN BUSINESS IS BAD YOU ARE GOT TO ADVERTISE - Henri Pioneer

An industry is an organization based on the principal of assosciated effort & refer to complete body including all its care function. The sudden acceleration of the technical & economic development resulted the expansion of industrial society. The main objective of any industry is to bring about the conversion of raw material, the manufacture of goods & the provision of service. SCHON Pharmaceuticals ( sterile product & capsule )& TEBLIK Pharmaceuticals Ltd ( Tablet, syrup, suspension & ointment ) professionally managed public Limited ISO certified company backed by the expertise of the pharma group with agood to serve the suffering mankind through their quality products & try to provide relief to the suffering on the humanity basis. The foundation of both company was laid down in year 1982 at 9/3 North rajmaholla Indore. After that the new plant is set up at 145/2 Jambudi, Hapsi Road Indore. The company soon gets a reputed position in the market by increasing their product popularities.


QUALITY POLICY OF COMPANY The Company is committed to Total Quality Management.

The raw and packaging materials are procured either from approved vendors or reliable resources. These are received at the stores with all the necessary documents, which are properly scrutinized.

The Material received is first stored in the Quarantine area and label indicating "QUARANTINE"is affixed on all the containers of the lot received.

The Material received is immediately recorded into the stock records.

Sampling is done by the Quality Control Department in accordance with the SOPs for drawing samples for various materials.

Samples are tested by the Quality Control Department to confirm compliance to the prescribed specifications. The materials approved by the Quality Control Department are labeled "APPROVED" by the Quality Control Department.

The materials rejected by the Quality Control Department are labeled " REJECTED " by the Quality Control Department and such rejected materials are transferred to the REJECTED MATERIALS AREA. Rejected materials are promptly returned to the supplier or are destroyed (Destruction in presence of Q.A. Person).

The labels of "APPROVED " and "REJECTED"are controlled by Quality Control Department

Approved materials are dispensed to production in first in first out (FIFO) basis. Active ingredients are dispensed in a separate dispensing room.

Production is carried out under supervision of FDA approved technical staff, as per the prescribed processes and procedures.

There are prescribed provisions for in-process checks by the quality control and production department. The particulars of in-process checks carried out and the results thereof are entered in Batch Manufacturing Records (BMR).


The bulk is tested for compliance with the prescribed specifications, before these are filled in the primary container.

The finished products are tested as per the specifications.

All equipment in the manufacturing area are regularly cleaned, maintained and validated.

The Company has a well-equipped quality control laboratory. The instruments in the quality control laboratory are calibrated at regular intervals as per the SOPs.

Proper records are maintained for all calibrations.

Self-inspections are carried out regularly by the internal audit team.

There is well- defined procedure for handling product complaints.

The quality assurance department (Q.A.) scrutinizes each BMR. Products are released for dispatch only after Q. A. Approval.


COMPANY MANAGEMENT :

Mr. Anil Bhatia - Mr. Bhatia is M.Pharm. & having experience in the analysis and manufacturing of drugs. He is managing his own company . Mr. Anil Bhatia is Managing Director of the company.

Mr. S.P. Sharma - Mr. Sharma is B. Pharm. & is having experience in the analysis, manufacturing, marketing & managing the company. He is having about 28 years of experience in the pharma field. Mr. S.P. Sharma is Executive Director (Q.A. & Marketing) of the company.

Mr. S.N. Rathore - Mr. Rathore is M.Pharm. & having experience in the analysis and manufacturing of drugs. He has about 25 years of experience in the pharma field.Mr. S.N. Rathore is Executive Director (Production) of the company.

Mr. Rajendra Jain - Mr. Jain is B.Sc., M.A. (Socio.) and having experience of 23 years in manufacturing of Oral preparations. (Tablet, Liquid Orals, Capsules & Dry Syrup). He is approved in Tablet, Syrups, Capsules & Dry Syrup, and is production manager Tablet Section.

Mr. J. P. Gupta - Mr. J.P. Gupta is B.Sc. M.A. (Eco.) & is having experience of 26 years in manufacturing of Pharmaceuticals Formulations (Tablet, Ointment & Cosmetics)., He is also having experience in Food Products & Basic Drugs & having approval in Tabs., Ointment, Re-packing & Cosmetics., and is production manager of Ointment section.

Mr. P. K. Gupta - Mr. Gupta is B.Sc., M.A. (Eco.) and having experience of 18 years in manufacturing of Oral preparations. (Tablet, Liquid Orals, Capsules & Dry Syrup). He is approved in Tablet, Capsules & Dry Syrup, and is production manager Liquid Oral Section.

Ms. Antima Jain - Ms. Antima Jain B.Sc. & is having about 10 years of experience in Quality Control. She has experience of working in the Testing Lab., formulation-testing laboratories. She is approved in Chemical & microbiology. She is Q.C. Executive of the plant.

Mr. Vijay Purandare - Mr. Purandare is DE in electricals. He is having about 24 years of experience and he is Maintenance Incharge. He is responsible for the preventive maintenance and repairs of the machinery, equipment and utilities.


Mr. Ashok Yadav - Mr. Yadav is M.A. He is having about 11 years of experience in various industries and he is Personnel & Administration Manager. He is responsible for the Personnel , Administration, Liaisoning & HRD.


QUALITY CONTROL: Quality control can be defined as day to day control of quality with in the company. They are reasponsible for the acceptance or rejection of incoming raw material, packing components and finished products, for the myriad of in process tests and inspections, to assure that system are been controlled and monitered for the approval and rejections of complete dosage. Quality Control Result From:-

1. Team Work 2. Analytical testing of raw materials 3. Analytical testing of packing materials 4. Analytical testing of finished products 5. sampling under hygienic conditions 6. Monitering of Temprature in Q.C

Area Limit

1. Chemical Laboratory 25 ± 5°C

2. Instrument Room 25 ± 5°C

3. Microbiology Laboratory 25 ±3°C

4. Packing Storage Room 25 ± 5°C

5. Chemical Storage Room 25 ± 5°C

6. Control Sample Room 25 ± 5°C

The quality control function in an organization normally consist of atleast

three primary units-

• Analytical control

• Microbial control

• Packaging control


INSTRUNMENTS

A. CHEMICAL LAB

• Frontline ultrasonic cleaner

• Water bath

• Heater (ceramic plate)

• Friability apparatus

• M P apparatus

• Cyclo mixer

B. INSTRUMENTAL ROOM

• Magnetic stirrer

• B O D incubator

• Refrigerator

• Conductivity meter

• pH meter

• U V spectrometer

• Digital disintegration test apparatus

• Digital dissolution test apparatus

• M V titrator

• Polarimeter apparatus

• Antibiotic zone reader


• Karl fischer titration

• Digital colony counter

C. MEDIA PREPERATION ROOM

• Membrane filter (0.45 mu m.)

• Autoclave

• Incubator

• Vacuum oven

• Hot air oven

D. STERILITY CHAMBER

• Leak test of blister, strip & bottles by vacuum.


QUALITY ASSURANCE:

Quality Assurance creates the technical specifications regarded by the

Web community At large as Web standards. In ordered for these

standards to permit full introperability and access to all it is very

important that the quality of implemation be given as much attention as

standards development. There has always been and implematation of

quality assurance specification in both commercial and non-commercial

products.

The Quality Assurance (QA) Activity at quality assurance has a dual

focus to solidify and extended current quality practices, and to educateby

sharing out understanding of coordination, funding and tracking of the

quality of the products and services related to quality assurance

technologies. The mission of he QA team is to improve the quality of

quality of quality assurance specification implementation in the field. In

order to achieve that end, the QA activity :

• Works on the quality of the speciec themselves (exa: to make sure

they have a comformance section, a primer, clear text that is

unmbigious for developers, good layoit, consistency between

specifications, and in particulars, that they are coordinated with the

TAG).


• Promotes the development of good validations, test tools &

harmness for we & end users.

• Thinks ahead in terms of what additional steps could be taken to

achieve QA goals more efficiently, including certification,

education, & communication.


DOCUMENTATION

“It is a systematic & scientific process of collecting & recontrolling

variable data that is enable to satisfaction”

AIMS of documentation are

• To define the specification for all mantainance

• To define methods of manufacture & control

• To ensure that the personnel authorized to release a batch for scale

average it have all the information that is necessary to take the

decision.

• To provide information during investigation if a batch is suspected

to have defect

In India underschedule ‘U’ & schedule ‘M’ to the drugs and cosmetics

Rules that record are manes and path-own they are failing.

1. Batch reconciliation record

2. Environmetal control record

3. Raw material requiring sheet

4. Recovery addition sheet

5. Manufacturing instrunmentation

6. Bottle filling & washing record

7. Leakes test record

8. Finished goods release record


9. Personnel records

10. SOP records.

11. Packaging material record

12. Packaging record


TABLET SECTION PRODUCTION DEPARTMENT OF TABLET : Specially tablets and liquid preparation are manufactured in Teblik pharmaceuticals Ltd. TABLETS : According to IP pharmaceutical tablets are solid & biconvex discs, prepared by containing a drug or a mixture of drugs with or without diluents. In Teblik Pharm Ltd. Various type of tablets are manufactured like :

• Sugar coated tab. • Film coated tab. • Enteric coated tab. • Multiple coated tab.

For these production they required specific type of :

1. DILUENTS 2. BINDER ADHESIVE 3. DISINTEGRANS 4. LUBRICANTS 5. GLIDANTS & FLOW PROMOTERS 6. COLOURS, DYE & SWEETENERS


EVALUATION OF TABLETS : Tablets are evaluated for their chemical characteristics like potency, content uniformity & purity & physical characteristics like :

• Weight & weight variation. ( 20 Tab. ) Limit : 10% - 130 mg

7.5% - > 130 mg. 5% - > 325 mg. • Hardness – Pfizer & Monsonto tester • Thickness • Friability – friability apparatus • Disintegration test - tab. Time not more than 15 min. • Dissolution test – Dissolution apparatus. MACHINES :

1. Mechanical sifter 2. Multimill 3. Mass mixer 4. Fluidized Bed Dryer 5. Coating pan 6. Single rotatory 23 station machine 7. Tablet Blister packaging machine 8. Tablet strip packaging machine


TABLET MANUFACTURING FLOW CHART


PRODUCT PROFILE OF TABLETS

• ALPRAZOLAM • ALBENDAZOLT • B-COMPLEX • CETRIZINE 10 mg • CHLOROQUINE 250 mg. • DICLOFENAC SODIUM 50 mg • DOMPERIDONE 10 mg • NIMESULIDE 100 mg • PARACETAMOL TAB. • RIBOFLAVIN 10 mg • RANITIDINE 150, 300 mg • NORFLOXACIN 200 mg • METRONIDAZOLE 20, 400 mg • ETHAMBUTOL • ERYTHROMYCIN ESTOLATE 250 mg • ETHAMBUTOL 400, 800 mg • RIFAMPICIN, ISONIAZID TAB. • OFLOXACIN • PYRAZINAMIDE


SYRUP & SUSPENSION Syrups are sweet, viscous, concentrated aquous solution of sucrose or other sugars. Suspension : A pharmaceutical suspension is a biphasic system composed of finely divided insoluble solid material suspended in a liquid medium.

1. washing area – 16 bottle capacity (10ml-200ml) washing D. M. water 2. Filling - 4 bottles capacity at a time Belt conveyer 3. Seqling - single reading machine 4. Standardization – Inspection Visual dark / Light background

MACHINES :

• ROTATORY BOTTLE WASHING MACHINE • VOLUMETRIC LIQUID FILLING MACHINE ( 4 HEAD ) • BOTTLE SEALING MACHINE • STIRRER • COLLOID MILL • AUTOMATIC BOTTLE LABELLING MACHINE • CONVEYER BELT S.S (PACKING AREA) • CONVEYER BELT S.S (LIQUID LINE)


SYRUP & SUSPENSION MANUFACTURING FLOW CHART


PRODUCT LIST OF SYRUP & SUSPENSION:

• ANTITUSSIVE COGH EXPECTORANT Dextromethorphane Hydrobromide & Phenyl propanolamine Hydrochloride

• COUGH SYRUP Ambroxol HCL, Salbutamol syrup

• ANTICOLD SUSPENSION Cetrizine di HCL, Paracetamol suspension

• ANTI DIARHEAL Norfloxacin & Metronidazole suspension

• CALCIUM SYRUP Calcium syrup, Vita – B12 & D3, L- Lysine

• ANTIOXIDANTS & B-COMPLEX SYRUP • ANTIFUNGAL SUSPENSION

Nystatin susp.

• HAEMANITIC WITH ENZYME SYRUP Protein syrup with L-Lysine Mono HCL, Ferric Amm. Citrate, Niacinamide, Papain, Zinc chloride, Mg Chloride


OINTMENT SECTI ON OINTMENT SECTION Ointment is a semi solid preparation. Topical administration is employed to deliever a drug at or immediately beneath the point of application. Although occasionally enough drugs is absorbed in the systemic circulation to cause systemic effects. A large no. of topical medicaments are applied to skin , although topical drugs are also applied to eye, nose, throat, ear etc. FLOW CHART FOR OINTMENT SECTION


MACHINES :

• OINTMENT / CREAM MANUFACTURING TANK • WAX MELTING TANK JACKET • WATER PHASE CUM MANUFACTURING TANK • STORAGE TANK • TUBE FILLING CRIMPING & COATING MACHINE,

20 STATIO • WATER CIRCULATION TANK

PRODUCT LIST :

1. ANTILON ANTISEPTIC LOTION 2. NYASTATIN OINTMENT 3. HYDROCORTISONE ACETATE CREAM 4. NITROFLURAZINE CREAM 5. CETRIMIDE CREAM 6. AMR GEL 7. SILVERCIDE CREAM 8. POVIDONE OINTMENT 9. SHONAC CREAM


AMPOULES / VIALS (INJECTABLES) Injectables are sterile preparations intended for administration by injection, infusion or implantatation into the body. Manufacturing of sterile products are conducted by Schon pharmaceutical Ltd. Its proper prcessing is strictly carried out into the sterile are which is maintained by : A . FUMIGATION – Kmno4 + HCHO ( FORMALINE) B . LAMINAR AIR FLOW C . AIR HANDLING UNIT D . D.M WATER PLANT E . PROPER CLEANING SCHEDULE BY VARIOUS CHEMICALS F . HUMIDITY MONITOR G. ATM PRESSURE MONITOR Each processing were carried by well skilled persons in sterile section. So only trained persons are allowed & another are prohibited in this section. Before entering into this section we have sterilized Our self completely. in this section ampoules & vials of various drug were manufactured.


FLOWCHART OF MANUFACTURING OF STERILE

PRODUCTS :


PRODUCT PROFILE OF STERILE PRODUCTS :

• AMIKACIN 100, 250, 500 mg.

• AMOXYCILLIN 250 300 mg

• AMPICILLIN 250

• CLOXACILLIN 250, 500mg & 1 gm

• ATROPINE 10 ml

• DICYCLOMINE HCL 30 ml

• LIGNOCAINE 30 ml

• DICLOFENAC SODIUM 3 ml

• CHLOROQUINE 5 ml

• CEFAZOLINE SODIUM 250, 500 mg

• CEFOTOXAMINE SODIUM 125, 250 mg.

• MIETOCLOPRAMIDE 10 ml.


CAPSULE PRODUCTION Capsules re solid dosage form usually containing one dose of drug endlosed within a small, water soluble shell of a suitable form of gelatin.

A. Hard gelatin capsules : 000, 00, 0, 1, 2, 3, 4, 5.

• Processing of hard gelatin capsules :

Formulation of hard gelatin capsules. • Diluents • Protective sorbents • Gildants • Antidurting agent

B. EVALUATION OF CAPSULES : • Weight variation • Content uniformity • Disintegration test • Dissolution test Manufacturing of capsules is done by Hand Capsule filling machine.


FLOW CHART OF CAPSULE MANUFACTURING


PRODUCT PROFILE OF CAPSULES

• AMOXYCILLIN 250 & 500 mg. • AMPICILLIN 250 & 500 mg. • CEPHALAXIN 250 & 500 mg. • DOXYCLINE 100 mg. • TETRACYCLINE 250 & 500 mg. • FURASHON CAPSULES • BETA LACTUM CAPSULES • RIFAMPICIN 150 & 450 Mg. • CHLORAMPHENICOL 250 mg • OMEPRAZOLE 20 mg • CP-FLOX 250 & 500 mg • ZEEPLEX CAPSULES (MULTIVITAMIN WITH ZINC)


AIR HANDLING UNIT


CONCLUSION The four weeks industrial training proved to be a golden opportunity for us in letting us understand various operations involved in pharmaceutical industry. During our training period we came very close to all the aspects and analysis which we are carried out in the industry at the same time we learn how to follow the rules & regulation as per CGMP and GLP & according to WHO & ISO 9001 think that the company soon achieve a very good & reputed position on the country level. On the exposure to the industrial staff we found that the company staff is really hard working sincere & very co- operative in nature. On the whole, the company members work like family members and support each other. We are thankful and wishes the best for the welfare and letter achievement along with every worker of this company.

industrial training 02

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