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Transcript of My Industrial Training
Prepared & Presented BY :Abhishek Mishra
Semester-VB.E (Pharmaceutical Technology)
INDUSTRIAL TRAINING AT
ZYDUS CADILA HEALTHCARE LTD. ANKLESHWAR
Content
Introduction .
History.
QC Dept
Sections of QC Dept.
Raw material and Storage
In process( kf , FTIR, UV MP, )
GC and HPLC
Microbiology and Stability Section.
Conclusion n doubts ???
Vision statement
Zydus shall be leading healthcare provider with robust product
pipeline;
Stepping beyond the billion, we shall achieve of over USD 3
billion in 2015and be a research based Pharma company by
2020.
API shall contribute to this by being reliable service provider to
our customer, maintaining cost competitiveness through
Continuous improvement in process, offering quality product
keeping prime focus on environment, health safety…
Product Manufacturing in Ankleshwar (API
Division)
Amlodipine
Famotidine
Fluxetine
Hydrochloride
Tramadol
Loratidine
Meloxicam
Losartan
Glibenclamide
Fluconazole
Omeprazole
2/1
4/2
015
API DIVISION
(Active Pharmaceutical Ingredient)
In API Division the production of API’s was carried out
through process from raw material to finished product
“An API starting material can be material purchased from
one more suppliers under the contract or commercial
agreement, or produced In-house. API starting materials
normally have defined chemical properties and structure.
QA (Quality Assurance)
It is the way of preventing mistakes and defects in manufactured
products and avoiding problems when service is delivered to
Customers.
The basic two principle of QA are ….
1. Fit for Purpose – “the product should be suitable for intended purpose”
2. Right first time - “mistake should be eliminated”
It includes management of quality of raw material, assemblies,
products, components, service related to production and
management along with regular inspection processes.
Now in pharmaceutical industries GMP and cGMP are
very important aspects in an organization
cGMPs now generally recognize( QA- Compliance, QC-
Testing)
cGMP
QA Quality
Assurance
QCQuality Control
QC- Quality Control
QC is a process by which entities review the quality of all factors involved in production
QC emphasis on three aspects
Elements such as controls, job management, defined and well managed process, performance and integrity criteria, and identification of record.
Competence such as knowledge, skill, experience and qualification.
Soft elements such as personnel, integrity, confidence, organization culture, motivation, team spirit and quality relationship.
Responsibility
Responsibilities of QC unit
To Check and test the incoming material( raw material,
intermediates, in process samples) and declared the
result as per controlled specification whether it is pass
or fail and informed to QA Dept.
Documentation Room
In documentation section all the data and records are kept and stored by electronic software system.
Various kind of form that to be filled during analysis or testing of product.
SAP Form
SOP Form
COA Form
GTP Form
Specification Form
SAP formation: It is networking software having different modules for human resources controlling, finance, plant, maintenance, production planning, quality management, sales & distribution, etc.
Cont.
Quality management module of SAP:
Inspection lot processing.
Release of inspection lot physical sample drawing.
Result recording against inspection lot.
Usage decision against inspected lot.
COA printing.
Creation of physical sample
Raw material Section :
All material that to be used in manufacturing of
finished bulk (even though it is not present in
finished API e.g. certain solvents (Me-OH,
alcohols, acetone)) and material that to be used
in production of API called as raw material (it
can be KSM or non KSM). It can be either active
drug or inactive substance.
In this section the testing of raw materials & packing materials is
carried out and complete analysis of raw materials out using GC &
HPLC.
The following parameter is to be analyzed in this section as follows:
Description by physical appearance & odour.
Identification & purity testing by HPLC.
Detection sulfated ash & ignited residues by using muffle furnace.
Assay by titrimetry.
Water or moisture content by Karl Fischer apparatus etc.
In Process Section
In this section two types of analysis are carried out wet analysis and
instrument analysis.
In wet analysis the description solubility, clarity alkalinity and titration
test of compound are carried out.
Sample & intermediate from plant or production are analyzed in this
section and finished API sampling done by QA department and samples
are then analyzed in process section, samples can be from SRP (solvent
recovery plant) for analysis in process section.
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They register sample inward register data are to be
filled in register like batch no, inspected no, mfg qty;
batch qty; and sample qty.
Then they distribute sample for analysis to HPLC or GC
according specifications of material or intermediate.
Instruments in process section
Karl Fischer titrator.
Melting point apparatus.
FTIR (Fourier Transform Infrared Spectroscopy)
pH meter
HPLC
Gas Chromatography
Karl Fischer titrator.
The Karl Fischer titrator designed forfast volumetric moisture titration,providing the perfect solution toroutine measurements.
The advantages of Karl Fischertitrator are follows:
Fast titration results
Ultimate analytical performance accuracy
Push-button operation
Minimal training required
Compact setup
POlarimeter
A polarimeter is a scientificinstrument used to measure the angleof rotation caused by passingpolarized light through an opticallyactive substance.
Because many optically activechemicals such as sucrose, arestereoisomer.
Application
Steroids
Diuretics
Antibiotics
Narcotics
Vitamins
Analgesics
Amino Acids
Essential Oils
Polymers
Starches
Sugars
Melting point apparartus
The automatic melting point uses the latest technology in digital image processing to accurately identify the melt of up to three samples simultaneously.
It is used to determine M.P of product(API) , intermediate raw material during analysis.
Uv Spectrophotometer
To check the
absorbance/transmittance
of solution.
Absorbance , A of a
solution is defined as the
logarithm to base 10 of
the reciprocal of the
transmittance T for
monochromatic light.
FTIR
IR spectrum mainly used to measure the vibration spectrum or to detect the functional group under the examined by passing IR radiation through it.
Procedure of Sample preperation
Triturate 1 to 2 mg of the test sample under examination to fine in agate mortar with pestle to obtain a uniform sample in kBr.
Carefully grid the mix, spread it uniformly in die and press to obtain transparent disc about 0.1mm thick and 10-15mm diameter.
Put disc in holder and record the spectrum between 400cm-1 to 650cm-1 and compared with standard reference spectra.
Gas Chromatography
Gas Chromatography (GC or GLC) is a commonly used analytic technique in many research and industrial laboratories for quality control as well as identification and quantitation of compounds in a mixture.
GC is also a frequently used technique in many environmental and laboratories because it allows for the detection of very small quantities.
In this section testing of related substance present in volatile compound are carried out.
There are three models of GC:
PERKIN ELMER
SHIMADZU
AGILENT TECHNOLOGY
The GC having two types
Head Space-only vapor is used.
Head on- only liquid is used
Nitrogen Gas used as source and oxygen and hydrogen is used as flame.
Various Detectors used in GC
FID –Flame Ionization Detector.
TCD- Thermal Conductive Detector
ECD-Electronic Conductive Detector.
Cont.
HPLC is chromatography technique used to separate compounds that are dissolved in solution.
HPLC consist of a reservoir of mobile phase, a pump, an injector, a separation column, and a detector.
Normal Phase.- Polar stationary phase and non-polar solvent(moving).
Reverse Phase.- Non-polar stationary phase and a polar solvent(moving).
In this section testing has related to substance present in compound and their assay carried out. There are four models of HPLC
DIONEX
AGILENT
SHIMADZU
PERKIN ELMER
Software for HPLC Comparison:
Chromolion
Microbiology Section
In this section environmental monitoring of plant,process water testing & testing of finished API arecarried out.
There are mainly following types of testing is carriedout...
Growth Promotion test: check the growth promotingproperty of microbiological media used in microbiology lab.
Environmental monitoring of plant: check the microbialstatus of environment in clean areas of processing &packaging areas. It is done by sedimentation method & airsample methods.
Pathogen Testing : Check the Pathogen present in API
Microbial limit test : It is carried out for total viable count (bacteria &f fungi ) & and specified microbial species( coli, salmonella, staphylococcus)
Water Testing : following testing is carried out
1. Hardness test of pre-process and potable water
2. Free chlorine test for pre-process water
3. TDS (total dissolved solid) test of potable water.
Instrumental Analysis
Quantification of Total organic carbon in process water by
TOC analysis.
Quantification of microbial colony by colony counter.
Sections of Microbiology Lab
1. Documentation Room
2. Testing Section
3. Incubation Section
4. Changing Section
5. Storage section
6. Disposal Autoclave section
Instruments in Microbiology Lab
1. Incubator
2. Hot air oven
3. Autoclave
a). Vertical (for disposal of culture)
b). Horizontal (for sterilization purpose)
4. Referigator
5. Colony counter
6. Total organic carbon analyzer
Stability Section
In this section they store sample in
humidity chamber according to
respective pharmacopeia for specific
humidity limit & temperature to
determine shelf life of API or
intermediate.
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 you 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
2/1
4/2
015
Conclusion
• It was an amazing experience for us to seeactual QC process and documentation work .
• We also got an oppourtunity to learn GoodManufacturing Practice & cGMP GLP, SOP to befollowed in industry