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PROJECT REVIEW Priyanshu.docx
1. Page 1
A
PROJECT REPORT
SUBMITTED TO
Sri Sai University
Palampur-Himachal Pradesh
IN PARTIAL FULFILMENT OF THE REQUIREMENTS
FOR THE DEGREE OF
BACHELOR OF PHARMACY
SUBMITTED BY:
Priyanshu Thakur
Reg. No. 819011008
B. Pharmcy-8th Semester
2. Page 2
CERTIFICATE
This is to certify that Ms. Priyanshu Thakur, a student of department of pharmacy, Sri Sai
University has completed the compulsory Industrial Training (45 days) in the M/s Venus
Remedies Limited, Baddi (H.P) in India during summer vacation in the end of 3rd year of four-
year integrated B. Pharm degree course.
Place: Dr. Amit Sharma
Dated : Dean- Sri Sai University
Palampur-(H.P)176081
3. Page 3
ACKNOWLEDGEMENT
I consider it a great privilege & honor to have had the opportunity to undergo the industrial
training work in Venus Remedies Limited. Hence, I would like to offer my heartiest thanks to
Mr. Rakesh Thakur, (GM HR) and Mr. Arjun (HR Manager).
I am greatly indebted to Dr. Amit Sharma, Director, Dept. Of Pharmacy, for enabling us to have
the chance of industrial training and arranging such a nice arrangement.
I convey my heartiest thanks to Mr. Arvind (Senior Production Manager), Mr. Amit Kumar (QC
Manager), Mr Dilip Kumar Pandey (QA AGM), Tushar Agarwal (QA Executive), Anshul
Kumar(Executive Assistant) for their most valuable suggestions, constant encouragement, and
affectionate guidance during the period of this training.
I owe deep gratitude to the chemist Arvind Kumar for their support and guide to carry out the
task assigned to us while we are in the training. At last, I am greatly thankful to my Seniors in
Venus Remedies Limited for extending their constant cooperation which went a long towards the
completion of this Training and Report.
Priyanshu Thakur
Deptt. Of Pharmacy
Sri Sai University
Palampur
(H.P)176081
4. Page 4
PREFACE
Pharmacy is a profession which is concerned with the art and science of preparing suitable and
convenient material for distribution and use in the treatment and prevention of disease, so it is a
fully technical profession where practical knowledge is much more important along with
theoretical knowledge.
According to curriculum of a four-year integrated degree course of BACHELOR OF
PHARMACY each student has to undergo practical training for a period of four week in various
pharmaceutical industries in India. As it is to be done in the summer vacation of end of 3rd year
B. Pharma.
I was directed to undergo the training at “Venus Remedies Limited” and this report contains a
brief description of the above pharmaceutical industry which was observed during the training
program.
Priyanshu Thakur
Dept. Of pharmacy
Sri Sai University
Palampur
H.P-176081
5. Page 5
INTRODUCTION:
About Venus: The company is engaged in manufacturing products catering various segments
such as Oncology, Cephalosporins, Carbapenems and Other Specialties, Intravenous Products,
Vials/Lyophilized Injectables, Pre–Filled Syringes, Hormones, Ampoules and Biological
Products.
ORGANIZATION HISTORY IN DETAIL
Incorporated in 1989 as Venus Glucose Pvt Ltd the company was converted into public limited
company in 1994 and then changed into Venus Remedies Limited. The company was promoted
and managed by Chaudhary & Family. The company was mainly engaged in I/V fluids &
injectables ceftazidime amlodipine gliclazide lisinopril. The production was started in 1991 with
Intravenous/Intramuscular injectable forms at Panchkula district at Haryana. In 1994 it
introduced Eye/Ear/Nose drops. The company received the certificate as 'WHO-GMP' as
specified by WHO Geneva. Venus Remedies set up a Cephalosporin project with an Australian
collaboration with US-FDA standards at a cost of Rs.4.5 crores. The company is manufacturing
injections for the top companies like Panacea Biotech ltd Morepan Laboratories Ltd etc. In 2001
with the help of Product Development Committee(PDC) Venus Remedies had introduced 13 new
products in the Animal Health Division namely Megox-3000Paroxin-3000Pisa-
3000MicalRonidDexolyt and Detox.
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Global Footprint
Venus Remedies incorporated in 1989, is a pharmaceutical manufacturing company. The
company provides formulations in area of antibiotics and oncological therapeutics.
Company has two manufacturing facilities located in India and Germany. Company
manufactures Oncological and Cephalosporin Injectable products.
Its manufacturing facility located in India has received ISO 9001, ISO, 14001 and OHSAS 18001
for quality management. Its Germany facility follows EU–GMP norms.
Presently, the company has successfully made its presence in the markets of Philippines,
Thailand, Malaysia, Cambodia, Burma, Vietnam, Sri Lanka, Pakistan, Bangladesh, Nepal,
Uganda, Kenya, Botswana, Zimbabwe, Sudan, Mauritius, Yemen, Iraq, Russia, Belarus, Ukraine,
Costa Rica, Venezuela, Guatemala, Peru, Colombia, Ecuador, Syria, Yeman, Togo, Saudi Arbia
and Iraq.Company has entered into strategic alliances with various pharmaceutical companies
to launch its R&D based specialty products. It has tie–ups with companies namely IPCA
Laboratories, Elder Pharmaceuticals, Shreya Lifesciences, Cadila Healthcare, Glenmark
Pharmaceuticals, Marksans Pharma, Indoco Remedies, Karle Health Sciences, Lupin and
Jagsonpal Pharmaceuticals.Company also conducts in–house research and development
activities that focuses Formulation Development, NDDS (Novel Drug Delivery System), new
formulations of off patented chemicals and analytical and chemical research.
Products
The company is engaged in manufacturing products catering various segments such as
Oncology, Cephalosporins, Carbapenems and Other Specialties, Intravenous Products,
Vials/Lyophilized Injectables, Pre–Filled Syringes, Hormones, Ampoules and Biological Products.
7. Page 7
MILESTONE ACHIEVE
2009
Venus Remedies – Product Patent for "TOBRACEF" granted in South Africa.
Venus Bags Another Product Patent from South Africa for POTENTOX.
2010
Venus Remedies receives GMP Certification from Botswana".
Venus Remedies ties up with IMTECH and Punjab Univ to develop Typhoid detection kits.
The Company has received approval from the Reserve Bank of India for rollover of FCCB USD
5mn, with YTM @4% with maturity till February 15, 2015.
Venus Remedies research Blockbuster "Sulbactomax" gets European Union Patent"
2011
Venus Remedies Ltd wins Gold Medal for TROIS under DST – Lockheed Martin India
Innovation Growth Program 2011.
Venus launches its patented research product ACHNIL” in India.
Venus Remedies wins ""India Manufacturing Excellence Award 2011.
2012
Venus Remedies introduces "Ready–to–Use"" Single Vial Taxedol in India
Venus Remedies Limited introduced TROIS that is a research based, patent protected topical
nano–emulsion product in India
The Company has won Manufacturing Award for its world class manufacturing and operational
excellence at the "Industry 2.0 Manufacturing Innovation Conclave 2012.
Venus wins Patent award in Silver Category.
8. Page 8
VISION AND MISSION OF THE ORGANIZATION
Vision: We strive to touch the lives of patients by actively listening and responding to their needs
with breakthrough innovative products and medical expertise that is critical for understanding
and treatment of diseases.
Mission :
. TO ESTABLISH VENUS AS AN INNOVATOR COMPANY.
. TO CREATE INTELLECTUAL PROPERTY WEALTH OF ONE BILLION US DOLLAR.
. TO ENSURE COMMERCIALIZATION OF INTELLECTUAL PROPERTY RIGHT OF THE
COMPANY WORLD WIDE.
. TO ESTABLISH SULBACTOMAX AS RUPEES 100 CRORE BRAND.
. TO ESTABLISH SULMACTOMAX AS RUPEES 100 CRORE BRAND.
. TO MAKE SULMACTOMAX/SEPTILOC–AMPUCARE/POTENTOX AND VANCOPLUS
AS GLOBAL PRODUCTS.
. TO MAKE EVERY DEPARTMENT AS AN INDEPENDENT PROFIT CENTER.
. TO ACHIEVE NEW HEIGHT BY CREATION OF VENUS INDUSTRIAL COMPLEX.
. TO DEVELOP AND SUSTAIN A HIGHLY MOTIVATED AND EMPOWERED TEAM
FOR REALIZATAION OF SELF PROGRESSIVE SOCIETY DREAM.
. BE A GLOBALLY ADMIRED PHARMA COMPANY FOR WORLD CLASS QUALITY
AND INNOVATIONS.
9. Page 9
PRODUCTION SECTION
Instruction and Precautions
Ensure area and equipment cleanliness before starting the manufacturing operations.
Check and ensure that all manufacturing equipment and other required accessories are
clean ready for use.
Wear gloves and nose mask during all manufacturing process.
Counter check the weights of all manufacturing process.
Get line clearance from QA for manufacturing.
Air handling unit (AHU) system should be kept ON throughout the manufacturing
process.
Temperature should be kept between 250c ± 20c and relative humidity should be kept
between 50 ± 10 %, temperature and humidity standards change with respect to
formulation.
Ensure that only QC approval purified water is being used for manufacturing purpose.
Always transferred solution to the manufacturing vessels through 20 meshes.
During the preparation of this product, no other products processing should be done in
same area.
Whenever shifting through SS mesh is involved; check the mesh integrity before and
after use.
All critical aspects during manufacturing like temperature, duration of mixing, weight,
etc. must be checked and recorded by the supervisor.
Supervisor to ensure completion of all in-process record during various stages of
manufacturing operations till completion of the batch.
Release from QA should be taken from all in-process tests mentioned in batch
manufacturing record.
No over writing is allowed in batch manufacturing record. If initial data is wrong entered,
cancel the data by single stroke arrow and put initials. Record reasons for changes as
foot-note on the same page.
All the details whatever is necessary should be related in batch manufacturing record
(BMR).
Send a test request from QC after manufacturing is completed.
Check all polyethylene bags before and after material loading for black particles and
sealing.
Check calibration of respective equipment/machine before use.
PRODUCT MANUFACTURING
Sr. No. Generic Name
1 Ceftriaxone
2 Cefepime
3 Cefotoxime
4 Ceftriaxone + Sulbactum (With EDTA)
5 Cefoperazone + Sulbactum
6 Ceftriaxone + Vancomycin
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REPORTING DAY
I greeted the security officer and asked them for Mr. Rakesh Thakur(HR head). I told them that I
am the student of Sri Sai University and I came here for the 45 day summer training. Security
officer allow me to enter in their office.I kept my mobile and electronic gadget in the locker
according to their security rules. I did our entry in the training register. Before entering in
Industry premises security person checked our pockets properly and then he escort to the
reception. I waited there for 5min, and then receptionist escort us to the HR Manager office
where we met Mr. Rakesh Thakur (HR head). I gave them our summer internship letter and
asked them for permission of one month training. He allows me and told some basic rules and
regulation of their industry. HR Manager hired one trainer (Mr. Tushar Agarwal and Mr.Anshul
Kumar) for us who helped me in knowing about the working process of different department
present in industry.
Entry procedure for primary change room
Wash your feet under the feet shower.
Wash your hands with soap in wash basin.
Dry feet with the help of feet drier.
Dry hand with the help of hand drier.
Enter the primary change room II (B)
Wear the company Uniform.
Wear the company footwear.
Enter the secondary corridor.
By wearing primary uniform and footwear we can enter only in storage area. For
Production area we have to pass through secondary change room.
Entry procedure for inside production area
Press the door interlock button to open the door.
Remove the primary footwear.
Wear secondary footwear.
Wear boiler suit.
Put on nose mask.
Sanitize hands with hand sanitizer.
Open the door and enter into packing and production secondary change room.
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Exit procedure from inside production area
Open the door, Degowning the Boiler suit and exit from manufacturing primary change
room.
STORAGE AREA
In Venus there are 4 major different types of storage areas:
1 Primary material store
2 Raw material store
3 General store
4 Finished goods store
Also having some small storage areas:
1 Quarantine storage
2 Cold room
3 Rejected material store
1 Primary material store: contain 12 mobile racks for proper storing of primary materials
that are:
Sipper
PVC
Carton
Maintaining the humidity 26.5% and temperature 24.50c
2 Raw material store: contain 12 mobile rack for proper storing of approved raw materials.
Temperature sensitive drugs are store in cold room.
3 General store: here we store general need items like pen, paper, printer rims, tapes,
stapler, shoe cover mask, caps etc.
4 Finished goods store: it contains 10 mobile rack in which 3 are for under test product and
7 for approved product.
Dispensing:
Weighing & dispensing process in Pharma industries plays an indispensable role. The increased
regulations on the manufacturing processes in Pharma manufacturing industries led the focus and
resulted in the advanced technology and strict policies and frameworks.
Using the weigh and dispense process technology, the pharmaceutical companies can enhance
the speed and accuracy of their operations. On the other hand, weighing and dispensing of solids
& liquids is a very common activity throughout the pharmaceutical industry processes. Pharma
materials are dispensed by hand-scooping solids and pumping or pouring liquids. This process
13. Page 13
can be done in a warehouse during chemical production or in a pharmacy during pharmaceutical
dosage-form manufacturing. Due to spills, leaks and fugitive emissions, weighing and dispensing
requires high end and workplace control measures are required to protect workers. Hence,
weighing and dispensing should be performed in a partitioned workplace area with good dilution
ventilation.
Disp
ensi
ng
Boo
th
Pict
ure
15. Page 15
Manufacturing:
The manufacturing of sterile injectables is a complex process that demands pharma
manufacturers to follow guidelines to ensure an injectable product is safe and effective. This
means that the product must be produced to standards of quality, purity and sterility that is
uncompromising.
Manufacturing Tank Diagram
Before start of manufacturing the CIP and SIP of manufacturing tank done to reduce Bio load
and avoid any type of Microbial Contamination
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CIP:
The CIP solution return system should be designed to maintain a very small puddle of liquid in
the bottom of a vessel. A puddle 50 mm deep in the vessel being cleaned is acceptable in order to
prevent the CIP return pump from binding air. Usually a CIP return pump is selected with a
capacity that is 10–25% higher than the CIP supply pump because the CIP return pump has to
handle liquid and also a lot of air. The CIP return pump may have to pump a 50/50% air/water
mixture. This is especially true if vortexing takes place, which can prohibit proper tank draining,
ultimately causing flush, wash and rinse solutions to accumulate in the vessel. A vortex, which is
a common problem in round bottom tanks with centre outlet, partially blocks the exit area,
restricting the flow, and trapping air in the return stream (Fig. 10.41(a)). That air may
subsequently cause the CIP return pump to become ‘air-bound’. Once the CIP return pump is air-
locked, flow in the CIP return line will soon stop and cleaning or rinsing solution will
accumulate in the process vessel.
SIP:
SIP (Sterilize, or Steam In Place) is a timed sterilization of the upstream and downstream
biopharmaceutical production train using clean steam. It is part of a 5 step sanitization routine
that occurs after every production batch, and follows the final rinse after CIP (Clean In Place).
SIP ensures that every square inch of the production train that comes in contact with drug
substance inputs, drug substance, or the final drug product is “sterilized” to ensure thatthere is no
microbiological activity in the system. Clean Steam (made from USP Purified Water) is
circulated through all of the process tubing during this stage, and enters large vessels through
spray balls embedded in the vessel ceiling. SIP is a temperature validated process, meaning that
the sterilization event must be proven by measuring the temperature of the event and recording
the data. The minimum sterilization regimen requires the injection of clean steam into all piping
and vessels for at least 1/2 hour after they reach a minimum temperature of 250°F (121°C). Ifthe
temperature ever falls below 250°F (121°C) during the temperature hold period, a temperature
validation fault is recorded, and SIP must be repeated.
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CIP/SIP Skid Diagram
Vial Washing Machine:-Vial washing machines are designed to effectively wash Vials. Whether
it’s a small vial or a large, a proper wash is essential to the quality of a final product. Automatic
vial washing machines are equipped with a patented spray nozzle that guarantees a reduction in
particulate matter.
Working Principle of Vial Washing Machine:
The washing process begins with the vials being fed into the in-feed turntable and transferred to
the out feed end by a conveyor. Once the nozzles are lifted, another set of nozzles automatically
sprays air on the vials to dry them completely. Once the nozzles are removed, the cycle is
complete and the vials can be reused. In this way, vials are cleaned efficiently.
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Depyro
genatio
n:-
Depyro
genatio
n refers
to the
remova
l of
pyroge
ns from
solutio
n, most
commo
nly
from
injectable pharmaceuticals Tunnel used in pharmaceutical industry for depyrogenation.
Depyrogenation Tunnel:-
Depyrogenating Tunnel’s generate dry heat that provides complete sterilization than other
automated or manual processes because it reaches all surfaces, including cooling coils, fan
wheels, HEPA filters and the conveying system.
19. Page 19
Vial Filling, stoppering and Bunging machine:
Vial Filling and Stoppering Machine is suitable to fill injectable glass vials. The basic unit
consists of turntable, Stainless Steel Stat conveyor belt, unique eccentric pre-gassing, filling and
post-gassing. Highly efficient and precision built Stainless Steel 316L Syringes, non- toxic
synthetic rubber tubing and easy reach compact panel.
The minimal distance between filling and stoppering units reduces the risk of contamination. The
machines are designed for operation in a sterile area and for use under laminar flow protection.
The un-scrambler itself has been redesigned to eliminate dead ends and difficult-to-clean spots.
Process Operation :
The incoming dry vials (sterilized and siliconized) are fed through the unscrambler and suitably
guided on the moving delrin slat conveyor belt at the required speed of the correct placement
below filling unit.
The filling unit consists of Filling Head, Syringes & Nozzles; Syringes & Nozzles are made of
AISI SS 316L materials. A Star Wheel is provided which holds the vial during filling operation.
A sensor is provided for ''No Vial-No Filling'' operation. Syringes are mounted on eccentric
block and driving through bottom main gear box. Volume can be increase & decrease by
increasing or decreasing stroke length of piston as per filling size. Syringes is having non return
20. Page 20
valve for sucking and delivering situation to avoid volume variation. Liquid reaches to filling
nozzles through silicon transparent pipe. Nozzles having up & down movement with help of cam
mechanism and it come down when vial hold by starwheel for filling operation and starts filling
when it starts to move up and after completion of filling operation, starwheel delivers
two/four/eight vials together on conveyor for rubber stoppering operation.
Stoppering unit consist of Starwheel, Vibrator unit and Bowl. The sterilized and siliconised
rubber stoppers stored in the vibrator bowl moves vertically to the rubber stopper chute. The vial
is hold firmly by starwheel, which will be in continuous rotary motion and vial which is coming
from filling unit get in to starwheel and move in rotary direction along with starwheel, during
movement it picks up the rubber stopper from the exit end of the chute and rubber stopper
pressed by fix single pressing roller, which is spring loaded. Then vial further move on conveyor
and collected on out feed starwheel for next sealing operation
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Vial Filling Stoppering and sealing Machine Diagram
Autoclave:-The autoclave is a steam sterilizer, It is used for various sterilization functions. In the
pharmaceutical industry, autoclave has a vast use in injectable manufacturing section and
microbiological laboratory. In the injectable section, it is used for sterilization of glass vials and
filling equipment. Autoclaves provide a physical method for disinfection and sterilization. They
22. Page 22
work with a combination of steam, pressure and time. Autoclaves operate at high temperature
and pressure in order to kill microorganisms and spores.
IPQC:-
In Process Quality Control
IPQC refers to the quality control during the assembly process. It is very important because you
can detect and handle the problem that occurs ahead of time. In this stage we do the pH,
23. Page 23
Description, Specific gravity, BET ,Bioburden etc.
Equipments used to for IPQC test are:-
1. pH Meter: A pH meter is a scientific instrument that measures the hydrogen-ion activity in
water-based solutions, indicating its acidity or alkalinity expressed as pH.The pH meter measures
the difference in electrical potential between a pH electrode and a reference electrode, and so the
pH meter is sometimes referred to as a "potentiometric pH meter". The difference in electrical
potential relates to the acidity or pH of the solution. The pH meter is used in many applications
ranging from laboratory experimentation to quality control.
24. Page 24
2.Conductivity Meter: A conductivity meter or conductimeter fulfills the function of measuring
the amount of electrical current or conductance in a solution. For example, the conductimeter is
the instrument used in order to know the conductivity (electrical charge) in a body of water of
natural origin.
PH Meter
Diagram
26. Page 26
Procedure for Injection Manufacturing
First material comes in Quarantine store
Sample of raw material send to QC department
Assay and LOD test done in QC
(To determine how much API used for batch and other excepients)
After passed the QC test put the raw material in approved area
Send request to store for raw material (which is used in manufacturing area).
Raw material sends to dispensing booth (RLAF)from raw material storage area
Weigh one material at a time
First excepients then API are weight.
(Minimizing the risk of cross contamination in dispensing booth)
CIP/SIP of Manufacturing Vessel and Cleaning and Autoclave of Accessories.
Manufacturing
Collect The WFI in Manufacturing tank
27. Page 27
Then Add the Excipients into it
Mixing done as per Batch record mentioned RPM and time
Then Add API into it and mix s per Batch record mentioned RPM and time
Adjust the PH and send the sample to qc.
Parallel the Autoclave load of Machine parts and filtration accessories prepare and then
sterilized them in autoclave
After the QC result passed the filtration started
Filter the product through 0.2micron filter to make product sterile.
Assemble the M/C parts and then transfer the solution to Filling area
Then perform the aseptic connection of holding tank with filling machine
Then Filling started as per validated speed.
After Completion of filling the vials end for Visual Inspection
The sample of visually good vials send to qc for analysis
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The Visually good vial transfer to Quarantine area with label ready for packing.
After the QC passed the batch then the batch transfer to packing area for packing as per
requirement received from market.
The product was then stored in finished goods storage room.
Then the product was dispatch from company according to demand.
IN VENUS REMEDIES A STANDARD OPERATING PROCEDURE ARE USED TO
MANUFACTURE THE PRODUCT.
QUALITY CONTROL SECTION:
Quality control is the part of GMP concerned with sampling, specification and testing with organization;
documentation and release procedures which ensure that necessary and relevant tests are carried out and
that materials are not released for sale or supply, until their quality has been judged satisfactory.
Quality control (QC) laboratory, ensures that the products are pure, safe and effective and are released
only after thorough analysis as per stringent specifications, methods and procedures developed according
to international guidelines viz. EU GMP, WHO, SFDA etc.
The QC department performs following activities:
29. Page 29
Activities of quality control department were:
Testing and release or rejection of all incoming raw materials, packing materials, in-
process/intermediates and finished products as per specified specifications.
Maintaining testing records as per standard procedures for raw materials, in-process/intermediates
and finished products.
Calibration of laboratory instrument/equipment.
Performing stability study
Analytical method validation
Preparation of standard volumetric solutions and maintain standardization record.
Maintain labeling procedure at all the stages and records.
Maintain working/reference standard record of products.
Analysis of complaint samples as and when required.
Follow safety norms at all the stage during handling of chemicals and using instruments.
Follow good laboratory practices.
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Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as
safe and therapeutically active formulations whose performance is consistent and predictable. New
and better medicinal agents are being produced at an accelerated rate. At the same time more exacting
and sophisticated analytical methods are being developed for their evaluation.
Different types of tests are performed for different material. The types of test performed for each
material are as follows-
1 Testing purified/WFI water
2 Testing uniformity of Solution
3 Particulate Contamination test
4 Dissolution test
5 In-process quality control
6 HPLC
7 Assay of different Products
8 Organic Impurities test.
Quality control test for material by QC department
For different materials and dosage form different tests are performed, following of them are-
Test for raw materials-
For testing of raw material following test are performed according to SOP:
Description or physical appearance (crystalline, powder, smell, color)
Solubility (solubility is check by dissolving in alcohol, chloroform or in water if substance
organic in nature and non polar will dissolve in alcohol and chloroform and if substance is
inorganic and polar in nature will easily dissolve in water)
Identification (identified by using FTIR, TLC, UV spectrometer)
pH (checked by pH meter, pH should be within range as recommended by official book)
Viscosity (viscosity is checked by viscometer and it should be within range as recommended
by official book)
Assay (percentage purity of sample is checked by analyzing the sample by using U.V
spectrometer or HPLC, FTIR but mostly used apparatus is U.V spectrophotometer)
LOD (Loss on drying)
Wt. of empty petri-dish = A
Wt. of petri-dish + sample = B
Wt. of sample = B-A= C
After drying at 105℃ for 30 minutes wt. of petri-dish + sample = D
Difference between wt. before drying and after drying = B-D = E
% LOD = E/C X 100
31. Page 31
Test for Injection-
For finished product following test are performed-
Description
Identification by IR
Constituted Solution
Particulate Matter
Uniformity of Dosage Unit
PH
Water
BET
Sterility
Assay
INSTRUMENTS SEEN IN Q.C DEPARTMENT:
Different instruments are use for testing in Q.C department:
Sample collector
Syringe pump
Dissolution apparatus
pH meter
Water bath shaker
Media preparatory
Polarimeter
Agilent HPLC
Water HPLC
Conductivity meter
Centrifuge
UV chamber
Sonicator
UV Spectrophotometer
Fourier transform infrared spectrophotometer
Vacuum oven
Analytical balance
Hot air oven
MICROBIOLOGY SECTION-
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In this section environmental monitoring of plant, process, water testing and testing of
finished API are carried out.
There are mainly following types of testing is carried out….
Growth promotion test- check the growth promoting property of microbiological media
used in microbiology lab.
Environmental monitoring of plant- check the microbial status of environment in clean
areas of processing and packaging areas. It is done by sedimentation method and air
sample methods.
Pathogen testing- check the pathogen present in API
Microbial limit test- it is carried out for total viable count (bacteria and fungi) and
specified microbial species (E. coli, salmonella, staphylococcus).
Water testing- hardness test, free chlorine test.
Instruments seen in microbiology section:
Autoclave- Vertical (for disposal of culture)
Horizontal (for sterilization purpose)
Incubator
Pass box
Laminar air flow
HEPA filters
Digital colony counter
Ultra micro balance
Microscope
Refrigerator
35. Page 35
In this section they store sample in humidity chamber according to respective
pharmacopoeia for specific humidity limit and temperature to determine shelf life of API
or intermediates.
Stability storage condition:
In stability rooms provide a stable temperature and/or humidity- conditioned
environment for worry free operation with a control system that is easy to use and
saves your time. These chambers are designed for stability studies and testing large
batches of product.
In this section they determine the shelf life of product and ensure that product in
market are within the stability period.
There are various stability study duration
Quality Assurance Department
Quality assurance (QA) is the sum total of organized arrangement made with the object of
ensuring that product will be of the quality required by their intended use.
Quality assurance is the systematic monitoring and evaluation of the various aspect of a project,
service or facility to maximize the probability that minimum standards of quality are being
attained by the production process. QA cannot absolutely guarantee the production of quality
products.
In Venus, there was a pharmacist to maintain the reliability at every stage of manufacturing
proceed starting from research ,clinical studies ,quality control, production, distribution and
provides information on appropriate use, and analyses safety and information of the products.
This department assists in the strategic direction and development of quality system, standard
operating procedures and document control programs, to ensure with the company policies and
regulatory requirement.
36. Page 36
ROLE OF QUALITY ASSURANCE IN INDUSTRY
Temperature check
Humidity checking
Line clearance
Shop Floor Compliance
Stability testing
Maintain record
Dispatch testing
Handing of market complain
Dispensing checking
In-process testing
SOP designing
Worker training
Validation
Self-inspection/internal audit
Art work
Market return
Monitoring of Handling of breakdown
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CONCLUSION
Industrial training is very much essential for pharmacy students. It is also great opportunity to
acquire practical knowledge. During my training period, in the industry I acquired lots of
experience in pharmaceutical production and production management. This will help me to
clarify my theory knowledge. I hope and pray that it will help me much in my future profession.
During our training period, we had seen the various instruments and apparatus in the industry.
The highly sophisticated instruments that work precisely must be operated with intense care for
optimum use. We could acquire a lot of information regarding the latest instruments and their
working procedures.
It was taught to us that, the CGMP guidelines are to be strictly followed in the industries in each
and every section.
Apart from all that, the training was very interesting with lots of things to be learned. It helped us
to acquire knowledge on punctuality, regularity and working environments in industries. The
friendly working environment in Venus Remedies Limited will remain in our mind in near
future. Hence, we can say that our goal of attending the industrial tour is fulfilled. We
acknowledge the great help “Venus Remedies Limited”.
