Escolar Documentos
Profissional Documentos
Cultura Documentos
AT
Duration: - 2 months
AFFILIATED TO
RAJASTHAN UNIVERSITY OF HEALTH SCIENCES, JAIPUR.
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ACKNOWLEDGEMENT
Every mature individual in professional life is keenly aware of his sense of ineptness to
many people who have stimulated and influenced his intellectual development.
Ordinarily, this feeling is expressed in customary gesture of acknowledgement.
Therefore, it seen as a right to acknowledge my gratitude with sense of veneration to the
Almighty GOD and various people who helped me during the course of Industrial
training. Their valuable guidance and wise direction have enabled me to complete my
practical training. Their valuable guidance and wise direction have enabled me to
complete my practical training in systematic and smooth manner.
I am also thankful all towards all other technical staff for giving their advice during
training.
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CONTENTS
1. Introduction
2. Company Organization
5. Production Department
• Tablets
• Capsules
• Oral Liquid
• Powder
6. Recent Products
7. Quality Control
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CHAIR PERSON:-
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ORGANIZATION OF QUALITY CONTROL:-
ORGANIZATION OF PRODUCTION:-
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Working of a Pharmaceutical Industry
Pharmaceutical Industry: - A Pharmaceutical Industry is an industry where life saving
drugs is prepared with excessive care and standards. So it is very different from other
industries.
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Cycle of Formulation Unit:-
1. Plant Development:-
• Plant and Premises
(a) Location and Surrounding
(b) Water Supply
(c) Sewage and Drainage System
2. Material Management:-
• Vendor Selection and Development
• Purchase System
• Status of the received material
• Assuring Water System
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3. Storage and Issue:-
• Control over Approval and Release of Materials
• Dispensing of Material
4. Production:-
• Manufacturing Process control and record
(a) MFR:- Master Formula Record
(b) BMR:- Batch Manufacturing Record
(c) BPR:- Batch Process Record
• Release by QC/IPQC
• Environment Monitoring
• Quality Audit of all record before release
• Complete and Satisfactory QC check before release
• Monitoring of finished goods storage condition
6. QA Activity:-
• Conducting Accelerated and Periodical Stability Studies
• Handling of Complaints, Rejection, Reprocessing and Recall
• Process and System Revival
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RAW MATERIAL STORAGE AREA
The store department of JPW is divided in two compartments, one for excisable and other
for non excisable goods. The product is sent to the receiver along with one copy of bill
which has information related to Name, Amount, Tax and final cost of the product.
The transporters consignment and a copy of bill are stored in commercial store. Entries of
in coming and outgoing goods are made in the same ledger. There are following auditors
assigned for inspections of records are:-
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1. Internal auditors- Check the ledger daily.
2. Excise auditors- Time to time check, especially for excisable goods.
3. Statutory auditors- Representatives of state govt., check through year.
1. Cold room – In which aluminum foil, empty capsules, loose drugs and vitamins
are stored. Temperature of this room is 15`c to 20`c.
2. Dispensing Room
4. Excepient Room
d. Essence Spearmint
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TABLET MACHINES / EQUIPMENTS:-
GRANULATION:-
1. Mass Mixer 110 kg. Capacity
2. Oscillating granulator
3. Multi-Mill
4. Fluid Bed Drier
5. Tray Drier
6. Sifter
7. Weighing balance 10kg capacity
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COMPRESSION:-
1. 16 Station rotary tablet compression machine
2. Air Conditioner
3. Punch and Die storage cabinets
4. Dehumidifier, Portable
5. Disintegration time test apparatus
6. Hardness tester, Monsanto, Pfizer type
7. Hygrometer + Thermometer
8. Vernier caliper (Japan)
9. Tablets Counters (different sizes)
10. Strip packing machine
11. Blister packing machine
COATING:-
1. Coating pan 36”
2. Coating pan 18”
3. Polishing pan
4. Hot plate
5. Hygrometer
6. Spray gun (750ml)
7. Fire extinguisher
8. Air Conditioner
PACKAGING:-
1. Blister Pack Machine
2. Stripping Machine
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CAPSULE MACHINES / EQUIPMENTS:-
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9. Hygrometer + Thermometer
10. Capsule counters (different sizes)
11. Disintegration time test apparatus
12. Capsule Inspection table
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ORAL LIQUID MACHINES / EQUIPMENTS:-
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15. ROPP cap sealing machine (four head)
16. ROPP cap sealing machine
17. D.M. Water plant CA-60
18. D.M. Water plant CA-33/1
19. H.D.P.E tank 300 ltrs.
20. Air Curtain
21. Fire extinguisher
22. Isectocutor
23. Bottle Labeling machine
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POWDER MACHINES / EQUIPMENTS:-
1.Octagonal Blander
2.Pouch filling and sealing machine
3.Sifter
4.Weighing balance
5.S.S. Vessels
6.Scoops
7.Air conditioner
1. Dehumidifier
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2. Dust Extractor
4. Weighing Machine
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1. TABLETS:
b. ALERCOLD TABLETS
Each uncoated tablet contains Cetrazine Hydrochloride BP 5 mg,
Phenylpropanolamine Hydrochloride BP 10 mg, Paracetamol IP 500 mg
c. ARTECRIS TABLETS
Each uncoated tablet contains Artesunate 50 mg
c. AZICRIS TABLETS
Azithromycin 500 mg
d. AZICRIS TABLETS
Azithromycin 250 mg
e. OCRIS TABLETS
Each film coated tablet contains Ofloxacin USP 200mg
f. ROBINAC TABLETS
Each enteric coated Tablet contains Diclofenac Potassium BP 50mg
Serratidopeptidase (as enteric coated granules) 10 mg
g. SPASCRIS TABLETS
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Each uncoated tablet contains Mefenamic Acid IP 250 mg, Dicyclomine
Hydrochloride IP 10mg
h. SURLOX TABLETS
Each film coated tablet contains Ciprofloxacin Hydrochloride IP Eq. to
Ciprofloxacin 250 mg
i. ELCET TABLETS
Each film coated tablet contains Levocetrazine Dihydrochloride 5 mg
j. NEUROCRIS TABLETS
Each uncoated tablet contains Mecobalamine 500 mg
2. SYRUP
a. ALERKOF SYRUP
Each 5 ml contains Chlorpheniramine Maleate IP 2 mg, Dextromethorphan
Hydrobromide IP 10 mg, Phenylpropanolamine Hydrochloride IP 12.5 mg
b. CRIMOX-DRY SYRUP
Each 5 ml contains Amoxicillin Trihydrate IP
c. APICRIS SYRUP
Each 15 ml contains Cyproheptadine Hydrochloride IP (anhydrous) 2 mg,
Vitamin B1 IP 2.5 mg, Vitamin B2 IP 2.5 mg, Vitamin B6 IP 0.75mg,
Niacinamide IP 22.5 mg, D-Panthenol IP 2.5mg
d. ASVIT SYRUP
Each 5ml contains Vitamin B1 IP 2.5mg, Vitamin B2 IP 1mg, Niacinamide IP 25
mg, Vitamin B12 IP 2.5mg.
3. CAPSULE
a. EZEE 20 CAPSULE
Each capsule contains Omeprazole IP 20 mg (as enteric coated granules)
b. CRIMOX-250 CAPSULE
Each capsule contain Amoxicillin Trihydrate IP Eq. to Amoxicillin 250 mg
d. CRIMOX-500 CAPSULE
Each capsule contain Amoxicillin Trihydrate IP Eq. to Amoxicillin 500 mg
e. LANCRIS-30 CAPSULE
Each capsule contains Lansoprazole 30 mg (enteric coated pellets)
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f. EZEE 20 PLUS CAPSULE
Each capsule contains Domperidone BP 10mg (coated pellets), Omeprazole IP 20
mg (as enteric coated granules)
3. SUSPENSION
a. NIMWIN-P SUSPENSION
Each 5 ml contains Nimesulide BP 50 mg, Paracetamol IP 125 mg
b. NIMWIN SUSPENSION
Each 5 ml contains Nimesulide BP 50 mg
c. OCRIS SUSPENSION
Each 5 ml contains Ofloxacin USP 50 mg
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QUALITY CONTROL
The concept of quality control refers to the process starving to produce a perfect product
by a series of measures requiring an organized effort at every stage in production.
Quality Control ensures product stability keeping the compliance to GMP going and
assures that product will retain all there claim till they are consumed. The sample should
be inspected for defects which could affect the performance or stability of the product.
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Procedure for Quality Control: - Step involved are:-
1. Raw Material Analysis: - After recording raw material in store division in store
division quality control dept is called for sampling for testing its quality and
purity as per pharmacopoeias. Where the raw material stand in its quality. The
quality control passes the raw material for production. For inspection two sample
from each of tablet, capsule and liquid section are selected. One is meant for
testing and another one is for storage. As the sample reaches the quality control
lab, it is recorded in the SAS register and a sampling slip is put in the sample.
A. 40 Tablet (min.)
B. 2 Liquid preparation (sealed)
C. 2 Sterilized preparation (sealed)
D. 40 Capsules
E. 2 Powder preparations (packed)
1. Electronic method
2. Solvent Extraction Method
3. Spectrophotometer Method
4. Chromatographic Method
Program adopted for observing GMP and to build quality of the product
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There are many tests that are used for quality assurance of various formulations as:-
1. Weight Variation: - A tablet must contain the proper amount of drugs. For
testing weight variation a sample of 10 tablets are taken hourly and weighted on
electronic or physical balance. The tablets must have acceptable average weight.
2. Friability Testing: - This is an internal standard test. This test is essentials for
consumer acceptance. Tablets require certain amount of strength to withstand
mechanism shocks on handling packing, and shipping.
5. Dissolution time: - As the tablet break down in small particles it should offer a
grater surface area to the dissolved media. Dissolution apparatus is a 8 paddled
machine and temperature, speed and time can be adjusted.
6. Strip leakage test: - To test whether the strips are leak-proof or not.
1. Clarity test
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2. Sterility test
For record maintenance in Q.C. there are separate recording registers, having columns
for the name, batch No, date & result for the product being analyzed e.g.:-
• One register for in process control analysis
• One register for raw material analysis
• One register for finished and packed product analysis
Daily entry is made to avoid any error. A part form this, for incoming of reagent in
Q.C. another record is maintained.
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