Project Report on Pharmaceutical Industrial Training

1. PROJECT REPORT ON INDUSTRIAL TRAINING AT -
SUBMITTED BY:
NEHA ROY
B.PHARM. 3RD
YEAR
SESSION : 2016-20
UNIVERSITYREG.NO. : 161860210059
UNIVERSITYROLL NO. : 18601916080
GURUNANAK INSTITUTE OF PHARMACEUTICAL SCIENCE
AND TECHNOLOGY

2. INDEX
 ACKNOWLEDGEMENT
 SMALL VOLUME PARENTERALS (SVP)
 TABLET
 ORAL LIQUIDS
 QUALITY CONTROL (QC)
 QUALITY ASSURANCE (QA)
 REVERSE OSMOSIS (RO) PLANT
 RAW MATERIAL STORAGE (RMS)
 BULK DRUGS
 OINTMENT PREPARATION
 CONCLUSION

3. ACKNOWLEDGEMENT
It is a matter of great pleasure and privilege for me to present this
report of six days industrial training. Through this report, I would like
to thank numerous people whose consistent support and guidance
has been the standing pillar in the architecture of this report.
To begin with, I express my sincere gratitude to Dr. Abhijit Sengupta,
Director & Principal of our college, GNIPST. Thanks to Ms. Jeenatara
Begum & Mr. Samrat Bose, Training & Placement Incharge (Asst.
Prof. of GNIPST); Dr. Lopamudra Datta & Dr. Sumana Chatterjee
(HODs); my mentor Dr. Prerona Saha (Dept. of Pharmaceutical
Chemistry, GNIPST) and all other teachers of our college, who gave
me support, encouragement and valuable suggestions throughout
the tenure of my training days.
I would also like to express my sincere thanks to Mr. Partha Adhikari
(Executive HR & Training Coordinator),who provided me with the
opportunity to undergo training at Albert David Limited, Kolkata.

4. SMALL VOLUME PARENTERALS (SVP)
Parenteral dosage forms are intended for administration as
injections or infusions. Common injection types are intravenous (IV),
intramuscular (IM), subcutaneous (SC). Others may include
intraperitoneal (IP), subdural (SD), etc.
The dept. of SVP is concerned with the formulation of parenteral
drugs. They come in 2 forms :
1. AMPOULES : A small scaled glass capsule containing a liquid,
especially measured qty. for injection.
2. VIALS : A vial is a small glass, or plastic vessel, or a small bottle,
often used to store medicament as liquid powder, or capsule.
They can also be scientific sample vessels.
AMPOULES VIALS
RULES TO BE FOLLOWED BEFORE ENTERING INTO THE SVP :
1. Wear shoecap.
2. Wear apron.
3. Do not leave your hair open.
4. Wear hair mask

5. The SVP dept. has 5 floors, thatare divided into 5 working areas :
 Clean-up area
 Preparation area
 Aseptic area
 Quarantinearea
 Packaging area
GROUND FLOOR :Here, the raw materials & packaging materials are
stored.
1st
FLOOR :
 Pre inspection
 Visualinspection
 Blister packaging
 Ampoule & Vial labelling
2nd
FLOOR :
Ampoule filling  Sealing  Sterilization
3rd
FLOOR :
 Multi-distillation column
4th
FLOOR :
 Air Handling Unit
 Heating Ventilation Air Condition System
 Storageof distilled water
 Storageof Water For Injection (WFI)

6. WATER DISTILLATIONDEVICE
STEPS FOR PROCESSING OF PARENTERAL :
 Cleaningof containers,closures&equipment
 Collectionof materials
 Preparationof parenteral products
 Filtration
 Fillingthe preparationinthe final containers
 Sealingthe containers
 Sterilization
 Evaluationof the parenteral preparation
 Labelling&Packaging
FORMULATION OFSVP:
Aqueousvehicle:
 Types:Purified Water(PW),WFI,Sterile WFI,BacteriostaticWFI
 Preparation:Distillation,Ion-Exchange,or Reverse Osmosis
 ExceptPW, all are pyrogen-free
Non-Aqueousvehicle:
 For purity,safety&biocompatibility
ADVANTAGESOF SVP:
 Quickonsetof action
 100% bioavailability
 Suitable fordrugs thatcannot be administeredorally
 Useful duringemergencies
DISADVANTAGESOF SVP :

7.  Injectionsmaybe painful and produce redness&swellingonthe administeredsite
 Difficulttoreverse administereddrugeffect

8. TABLETS
Tabletsmaybe definedasa unitsolid dosage formcontainingmedicament, withorwithout
excipients.
*As perIP, tabletsare definedassolid,flat,orbiconvex dishes,unitdosage form, preparedby
compressingadrug or a mixture of drug,withor withoutdiluents.
CLASSIFICATION :
 Chewable tablet
 Sublingual tablet
 Buccal tablet
 Uncoatedtablet
 Filmcoatedtablet
 Sugar coatedtablet
Excipientsused in tablets:
 Diluent:Eg. Lactose
 Binder: Eg. Starch
 Disintegrant:Eg. Cross-linkedPolyvinylpyrrolidone
 Lubricant: Eg. Silica
 Glidant: Eg. Magnesiumstearate
MANUFACTURINGPROCESSOF TABLETS :

9. METHODS FOR MANUFACTURINGOF TABLETS:
1. Dry Granulation
2. Wet Granulation
3. DirectCompression
,
BLISTER PACKAGINGDEVICE–
ADVANTAGESOFTABLET :
 Unit dosage formwithaccuracy, stable dose,greatprecisionandleastvariability
 Most stable w.r.t.physical,chemical &microbiological attributes
 Cheapestoral dosage form,easytohandle, attractive andelegantappearance
DISADVANTAGESOFTABLET :
 Drugs that are amorphousinnature and have low densitycharacter,are difficultto
compressintotablet
 Hygroscopicdrugsare not suitable forcompressedtablets
 Drugs that are sensitive tooxygenmayrequirespecialcoating

10. ORAL LIQUID PREPARATION
The BP 1998 & The EP 1997 definedOral Liquidsas,“solutions,emulsions,orsuspensionscontaining
one or more active ingredient(s) inasuitable vehicle”.
Liquidsfororal use may containsuitable antimicrobialpreservatives,antioxidantsandother
excipients,suchasdispersing&suspendingagents.
 Oral Solutions:Oral liquidscontainingone ormore active ingredientsdissolvedinasuitable
vehicle.
 Oral Suspensions:Containsone ormore active ingredientssuspendedinasuitable vehicle.
 Oral Emulsions:Containsone ormore active ingredients;theyare stabilized,oil-in-water
dispersions(o/w),water-in-oil dispersions(w/o),ormultipleemulsions.Solidsmayalsobe
suspendedinOral Emulsions.
 Mixtures: Containsone ormore ingredientsdissolved,suspendedordispensedinasuitable
vehicle.Suspendedsolidsmayseparate slowlyonstanding,butare easilyre-dispersedon
shaking.
 Oral Drops: These are oral liquidsintendedtobe administeredinsmall volumeswiththe aid
of a suitable measuringdevice.
 Elixirs:Elixirsare clear,flavouredoral liquidscontainingone ormore active ingredients
dissolvedinavehicle,thatusuallycontainsahighproportionof sucrose ora suitable
polyhydricalcohol oralcohols,andmaycontainEthanol (96%).Dilute ethanol elixirstendto
be usedfor potentor nauseousdrugs.Althoughethanol isawidelyusedsolventinelixirs,
highconc. may produce a pharmacological effect.Hence,the inclusionof polyhydricalcohols
such as glycerol,propyleneglycol,orsorbitol asco-solvents.

11. EQUIPMENTS USED IN ORAL LIQUID PREPARATION:
 Mixingand Storage Tank
 Packaging Equipment

12. ADVANTAGES OF ORAL LIQUIDS :
 Easiest route of administration
 Dosecan be taken in a measured qty.
 No nursing is required, i.e., a patient can take the preparation by
himself/herself
DISADVANTAGES OF ORAL LIQUIDS :
 Can’t be administered to an unconscious patient
 Delayed onset of action
 Not suitable in emergency cases
 Sometimes the medication itself is the causeof certain problems of the
GIT, which might lead to stomach ulcers

13. QUALITY CONTROL (QC)
The QC dept. is involved in a procedure or a set of procedures, intended to ensure that a
manufactured product or performed service adheres to defined set of quality criteria, or
meets the requirements of the clients or customer. QC is similar to, but not identical to
Quality Assurance (QA), which ensures the quality of the manufactured product as the
standards which are globally accepted.
INSRTUMENTS/EQUIPMENTS PRESENT IN QC :
 UV – Visible Spectrophotometer
 Solid – Sample Module (SSM – 5000A)
 TOC – V cph (Total Organic Carbon Analyser)
 HPLC (High Performance Liquid Chromatography)
 Liquid Chromatography
 Diode Array Detector
 Column Oven
 Fluorescence Detector
 Dissolution Test Detector
 Tap Density Detector
 High Precision Multichannel Pump
 Disintegration Tester
 Friabilator (USP)
 Cryoscopic Osmometer Printer
 KBr Press
 KF & pH meter

14. QUALITY ASSURANCE(QA)
QA ensures the quality of the manufactured products as the standards which are globally
accepted.
STEPS INVOLVED IN QA :
 HYGIENE
 PROPER SANITATION
 TRAINING
 CALIBRATION
 CONTAMINATION CONTROL
 VALIDATION
 WATER FOR PHARMACEUTICAL USE
 ASEPTIC PROCESS CONTROL
 MFG. EQUIPMENT
 PACKAGING & LABELLING
 PRODUCT CODING
 RE-WORK & RE-PROCESSING
 WAREHOUSING
 RETURNED PRODUCT
 PRODUCT RECALL
 REJECT/SCRAP DISPOSAL
 LABORATORY CONTROL
 IN-PROCESS CONTROL
 DEVIATION PROCEDURE
 STABILITY STUDY
 DOCUMENTATION
 SELF-AUDIT & CONTRACT MFG.

15. REVERSEOSMOSIS (RO) PLANT
RO is a water purification technology that uses a semi-permeable membrane to remove
ions, molecule and large particles from drinking water. In RO, an applied pressure is used to
overcome osmotic pressure, a colligative property.
RO can remove many types of dissolved and suspended particles/species fromwater,
including bacteria, and is used in both, industrial processes and in the production of payable
water.
PROCEDURES :
 Raw water sourcebore well (Coarsestrainer)
 Pre-treatment (Online coagulant, Polyelectrolyte & Hypochloritedosing)
 Pre-treated in 20klHDPETank
 Oxidation (Oxidation chamber), Filtration (MGF)
 StorageTank (100kl) RCC with epoxy-coated inner walls
 SMBS Dosing (T-1001,DP-1001), Softener (T-1002,SOF-1001)
 Micron CartridgeFilter (MCF-1101, 5 microns)
 RO Feed Tank (T-1101)
 ReverseOsmosis (ROM-1101A.B)
 RO ProductTank (T-1102)
 Mixed Bed Unit (MB-2101) Acid Tank + Caustic Tank
 1 micron Cartridge Filter (MCF-2101)
 Ultra Filtration (UF-2101-A,B,C)
 Purified Water Storage Tank (10kl)

16. RAWMATERIAL STORAGE(RMS)
Generally, the raw materials are materials used in the primary
production or manufacturing of goods and the place, wherethe raw
materials are kept or stored.
STEPS INVOLVED IN RMS :
 Receiving
 Sampling
 Storing
 Dispensing
PACKING MATERIAL STORAGE:
 Receiving of packing material
 Storing of packing material
 Issuing of packing material

17. BULK DRUGS
Bulk drugs aresubstances represented for use in the compounding,
manufacturing, processing, or packaging of a drug, that become active
ingredient or finished dosage form of the drug. However, “bulk drug
substance” shallnot include intermediates that are used in the synthesis of
substances.
At the Bulk Drug Dept. of Albert David Limited, Kolkata, the preparation of the
API, Sodium Stibogluconate(SSB) was witnessed.
SSG was prepared via chemical route, where all vessels were in contact with
the final productwhich are made up of Stainless Steel (SS).
STEPS INVOLVED IN THE PREPARATION OF BULKDRUG :
 Preparation of sodium antimony tartrate
 Preparation of antimony pentoxide
 Preparation of antimony gluconate
 Purification
 Concentration and crystallization
 Drying and Pulverisation
 Packing and Labelling of finished product

18. OINTMENT
Ointment is a semi-solid preparation that contains an API and other suitable
excipients intended for topical application, or application on skin. Itis
generally, a semi-solid, viscous preparation.
TYPES OF OINTMENTS :
 Non-Medicated : These ointments do not contain any drug(s). They may
be used as emollients, protectants. Eg.- Petroleum Jelly.
 Medicated : These ointments contain drug(s) which show any local or
systemic effects. They may be of the following types :
 Dermatologic Ointments
 Ophthalmic Ointments
 Vaginal Ointments
 Nasal Ointments
TYPES OF OINTMENTBASES :
1. Hydrocarbon Base
2. Absorption Base
3. Water- Removal Base (Cream)
4. Water- Soluble Base (Greaseless Ointment)
PREPARATION OF PHARMACEUTICAL OINTMENT:

19. DISPATCH PROCESS :
 Raw material entry
 Raw material storageat storageroomat roomtemp.
 Charging
 In-Processmaterialstorageat storagetank
 Tub filling
 Hand packing
 Master box packing and qyarantine
 Defective product
 Dispatch

20. CONCLUSION
Although the six days of our training at Albert David Limited, Kolkata flew very
quickly, with the cooperation of the authorities and all the personnel, I have
learnt and gathered a lot, about the pharmaceutical industrial field, which will
be helpful for me all the in many aspects. I am thankfulto the respective
authorities of Albert David Limited, who cordially received us and initiated our
curiosity and interest regarding the relevant subjects. I am pleased with
everyone’s behaviour and way of approach at the industry. Thus, I have
completed my training with great satisfaction, and hope that the feeling is
mutual.
Thank You.