Industrial Training Presentation on

Zydues Cadila Health care ltd.

SUBMITTED BY:-
AYUSH SHARMA
SR.NO.-58
TRADE-MECHANICAL ENGINEERIN
SUBMITTED TO:-
HOD OF MECHANICAL DEPARTMENT:-SH .D.R,SHARMA
 Index

 Quality Assurance & Quality Control

 Responsibilites of QA
 Responsibiltes of QC
 Relationship Between QA, QC and GMP
 Role of mechanical engineer in pharmaceutical companies
 Specific Roles
 Utility System Qualification for the Pharmaceutical Industry
 About AHU,Boiler,Air Cleaner &Air Compressor
 Flow Chart For Manufacturing Of Tablets In Pharmautical Industry
 About Cadila Healthcare Ltd
 QualityAssurance&Quality
Control
QUALITY CONTROL: ISO 9000 DEFINES QUALITY CONTROL AS "A PART OF
QUALITY MANAGEMENT FOCUSED ON FULFILLING QUALITY REQUIREMENTS".
IT IS THAT PART OF GMP CONCERNED WITH SAMPLING, SPECIFICATION &
TESTING, DOCUMENTATION & RELEASE PROCEDURES WHICH ENSURE THAT
THE NECESSARY & RELEVANT TESTS ARE PERFORMED & THE PRODUCT IS
RELEASED FOR USE ONLY AFTER ASCERTAINING IT’S QUALITY.
QUALITY ASSURANCE: ACCORDING TO WHO, QUALITY ASSURANCE IS A
WIDERANGING CONCEPT COVERING ALL MATTERS THAT INDIVIDUALLY OR
COLLECTIVELY INFLUENCE THE QUALITY OF A PRODUCT. WITH REGARD TO
PHARMACEUTICALS, QUALITY ASSURANCE CAN BE DIVIDED INTO MAJOR
AREAS: DEVELOPMENT, QUALITY CONTROL, PRODUCTION, DISTRIBUTION,
AND INSPECTIONS. ISO 9000 DEFINES AS "PART OF QUALITY MANAGEMENT
FOCUSED ON PROVIDING CONFIDENCE THAT QUALITY REQUIREMENTS WILL
BE FULFILLED"
 Responsibilites of QA

 Responsibilities of QA The QA department is responsible for

ensuring that the quality policies adopted by a company are
followed. It helps to identify and prepare the necessary SOPs
relative to the control of quality. It must determine that the
product meets all the applicable specifications and that it was
manufactured according to the internal standards of GMP. QA
also holds responsible for quality monitoring or audit function.
 QA functions to assess operations continually and to advise and
guide them towards full compliance with all applicable internal and
external regulations
 Responsibiltes of QC

 QC is responsible for the day-to-day control of quality within the

company. This department is responsible for analytical testing of
incoming raw materials and inspection of packaging components,
including labelling. They conduct in-process testing when
required, perform environmental monitoring, and inspect operations
for compliance. They also conduct the required tests on finished
dosage form.
 QC plays a major role in the selection of qualified vendors from
whom raw materials are purchased. Testing of representative
samples is required, and in many cases, an audit of vendor’s
operations is necessary to determine their suitability and degree of
compliance with GMPs prior to their being approved. The
environmental areas for manufacturing of various dosage forms are
tested and inspected by QC department.
Relationship Between QA, QC
and GMP
Role of mechanical engineer in
pharmaceutical companies
 Pharma companies have utility equipment (say boiler ,AHU ,chiller
,air compressor etc.)and process equipments (say granulator,FBP,
tablets ,syrup making and packing machine etc.)
 All those machinery need to be well conditioned and well
maintained as pharma companies have to go various audit at
regular interval from indian FDA and client country s FDA. All
machine sensors should be calibrated at regular intervals.This all
work is carried out by engineering department
Utility System Qualification for the
Pharmaceutical Industry
 Pharmaceutical equipment manufacturing is a highly regulated
industry. Given the stress on product quality and the widespread
impact of substandard production on public health and safety,
utility system qualification is a critical step that companies must take
towards ensuring that all their products comply with federal laws
and regulations.
 In pharmaceuticals, critical utilities like water and HVAC (Heating,
Ventilation and Air Conditioning) systems form the backbone of the
manufacturing process. As a result, these are treated, as products
that need to satisfy FDA regulatory requirements and
pharmaceutical manufacturing standards, just like raw materials
and other equipment used in the industry.
 Specific Roles

The manufacturing processes that pharmaceutical engineers can be

involved in include:
 Product conception, although this is often in laboratories and
research facilities rather than manufacturing plants
 Manufacturing the product
 Labelling the product and ensuring compliance
 Packaging the product to optimise distribution
About AHU,Boiler,Air Cleaner &Air
Compressor
 n air handler, or air handling unit (often abbreviated to AHU), is a
device used to regulate and circulate air as part of a heating,
ventilating, and air-conditioning (HVAC) system. An air handler is
usually a large metal box containing a blower, heating or cooling
elements, filter racks or chambers, sound attenuators,
and dampers.Air handlers usually connect to a ductwork ventilation
system that distributes the conditioned air through the building and
returns it to the AHU. Sometimes AHUs discharge (supply) and admit
(return) air directly to and from the space served without ductwork.
A fire-tube boiler is a type of boiler in which hot gases pass from a fire through one or (many)
more tubes running through a sealed container of water. The heat of the gases is transferred
through the walls of the tubes by thermal conduction, heating the water and ultimately
creating steam.
The fire-tube boiler developed as the third of the four major historical types of
boilers: low-pressure tank or "haystack" boilers, flued boilers with one or two
large flues, fire-tube boilers with many small tubes, and high-pressure water-
tube boilers.
An air purifier or air cleaner is a device which removes contaminants from the
air in a room to improve indoor air quality. These devices are commonly marketed
as being beneficial to allergy sufferers and asthmatics, and at reducing or
eliminating second-hand tobacco smoke. The commercially graded air purifiers
are manufactured as either small stand-alone units or larger units that can be
affixed to an air handler unit (AHU) or to an HVAC unit found in the medical,
industrial, and commercial industries. Air purifiers may also be used in industry to
remove impurities from air before processing. Pressure swing adsorbers or other
adsorption techniques are typically used for this.
The production of medicine requires machinery that can make formulas and bottle them in liquid and pill
form. From the mixing of ingredients to the labeling of bottles, every step must be implemented exactly
as detailed in the formula for a given medicine. In order for pharmacies to recoup their costs and stay
on top of market demand, it’s crucial that all the steps in each production be carried out quickly with the
utmost efficiency. Most importantly of all, each medicine must be produced in an environment that’s free
of germs, bacteria and contaminating oils.
The aforementioned can all be accomplished with an air compressor for pharmaceutical plant
productions.
Packaging machinery is used throughout all packaging operations, involving
primary packages to distribution packs. This includes many packaging processes:
fabrication, cleaning, filling, sealing, combining, labeling, overwrapping, palletizing,
etc
Flow Chart For Manufacturing Of
Tablets In Pharmautical Industry
About Zydus Cadila Healthcare
Ltd.
 Cadila Healthcare Ltd is a well known research-oriented, technology-
driven pharmaceutical company focused on the research areas of
biotechnology, formulations and Active Pharmaceutical Ingredients.
They are an Indian based pharmaceutical company having their
presence around the world. They are having their manufacturing
facilities at Ahmedabad, Ankleshwar and Vadodara in Gujarat, Ponda
in Goa, Raigad in Maharashtra and Solan in Himachal Pradesh.

Cadila Healthcare Ltd, the flagship of Zydus Cadila Group was

incorporated in May 1995 and they became a public limited company
in July 1996. The company's operation includes pharmaceuticals, which
includes human formulations, veterinary formulations and bulk durgs,
diagnostics, herbal products, skin care products and OTC products.
Zydus Healthcare Ltd. Baddi(H.P.)