The document describes an industrial training at Zydus Cadila Healthcare Ltd in Ankleshwar, India. It discusses the company's vision, the active pharmaceutical ingredients (APIs) manufactured, and an overview of the quality control department and its various sections. The quality control department ensures raw materials and finished products meet specifications through testing and analysis using instruments like HPLC, GC, and microbiological analysis. The training provided insight into good manufacturing practices and quality control processes required in the pharmaceutical industry.

1. Prepared & Presented BY :
Abhishek Mishra
Semester-V
B.E (Pharmaceutical Technology)
INDUSTRIAL TRAINING
AT
ZYDUS CADILA HEALTHCARE LTD.
ANKLESHWAR

2. 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 ???

3. 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…

4. Product Manufacturing in Ankleshwar (API
Division)
 Amlodipine
 Famotidine
 Fluxetine
 Hydrochloride
 Tramadol
 Loratidine
 Meloxicam
 Losartan
 Glibenclamide
 Fluconazole
 Omeprazole
2/14/2015

5. 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.

6. 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.

7.  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
QC
Quality
Control

8. 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.

9. 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.

10. Sections….

11. 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.

12. 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

13. Storage and Ware House

14. 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.

15.  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.

16. Sampling Procedure

17. 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.

18. 18
 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.

19. Process Flow

20. Instruments in process section
 Karl Fischer titrator.
 Melting point apparatus.
 FTIR (Fourier Transform Infrared Spectroscopy)
 pH meter
 HPLC
 Gas Chromatography

21. Karl Fischer titrator.
 The Karl Fischer titrator designed for
fast volumetric moisture titration,
providing the perfect solution to
routine measurements.
 The advantages of Karl Fischer
titrator are follows:
 Fast titration results
 Ultimate analytical performance
accuracy
 Push-button operation
 Minimal training required
 Compact setup

22. POlarimeter
A polarimeter is a scientific
instrument used to measure the angle
of rotation caused by passing
polarized light through an optically
active substance.
Because many optically active
chemicals such as sucrose, are
stereoisomer.

23. Application
 Steroids
 Diuretics
 Antibiotics
 Narcotics
 Vitamins
 Analgesics
 Amino Acids
 Essential Oils
 Polymers
 Starches
 Sugars

24. 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.

25. 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.

26. 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.

27. 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.

28. 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.

29. 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.

30. Process Flow of GC analysis

31. HPLC

32. 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).

33.  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

34. HPLC DIAGRAM

35. Process Flow

36. Microbiology LAb

37. Microbiology Section
 In this section environmental monitoring of plant,
process water testing & 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 &
packaging areas. It is done by sedimentation method & air
sample methods.
 Pathogen Testing : Check the Pathogen present in API

38.  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.

39. Instrumental Analysis
 Quantification of Total organic carbon in process water by
TOC analysis.
 Quantification of microbial colony by colony counter.

40. Sections of Microbiology Lab
1. Documentation Room
2. Testing Section
3. Incubation Section
4. Changing Section
5. Storage section
6. Disposal Autoclave section

41. 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

44. 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.

45. 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

46. 2/14/2015
Conclusion
• It was an amazing experience for us to see
actual QC process and documentation work .
• We also got an oppourtunity to learn Good
Manufacturing Practice & cGMP GLP, SOP to be
followed in industry

47. 2/14/2015
Thank you...