INDUSTRIAL PHARMACY-II MODEL PAPER

SECTION A
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VERY SHORT ANSWERS TYPE QUESTIONS (10 × 2 = 20)
1. Define pilot plant.
Answer
• A pilot plant can also be defined as the pre-commercial production system
which includes new production technology and produces small volumes of
new technology-based products.

2. Describe platform technology.

Answer
• Platform technologies are systems that distribute the system out into different
levels of abstraction. This is done in order to differentiate between core –
platform – functions, and the application layer that sits on top of, and draws
upon, these underlying common services.

3. Define confidentiality agreement.

Answer
• The aim of a confidentiality agreement is to protect all information of party
entering negotiations. Before any concrete negotiations on the transfer of a
technology can really start all parties involved must be able to evaluate the
technology offered.

4. Discuss the practical aspects of Commercialization.

Answer
Technology transfer are discussed with certain practical studies.
Case Study 1
Factors considered in the proposed technology transfer (scale-up)
• Geometric Similarity: Ratio of all lengths constant (constant fill ratio)
• Dynamic Similarity: Maintenance of Forces (Froude number)
• Kinematic Similarity: Maintaining a consistent number or revolutions
Scale-up in QbD Approach: Blending
Amou Blender Blending Blending Volume
Scale nt Capacity Speed (rpm) Time (min) Nrev FillRatio
(kg) (%)
Laboratory 2 8 qt 25 12 300 ~50
Pilot 40 7.5 cu.ft 15 20 300 ~50

Commercial 18 30 cu. 10 30 300 ~50

0 Ft

Conclusion of case study 1: The desired content uniformity was attained by

modifying the above parameters such as blending speed and blending time.
5. Explain Drug metabolism and Toxicology.
Answer
Drug Metabolism
• The drug metabolism studies needed to characterize the fate (whether the
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compound is changed and to what) of a lead or drug candidate in the body.
Metabolism studies carried out by both in-vitro and in-vivo methods.

Toxicology
• Toxicology defines the preclinical part of the safety assessment during drug
development. By conducting toxicity studies, possible hazards and risks are
identified.
o Acute toxicity (Single dose) and Chronic toxicity (Repeated-dose) study
o Reproductive toxicity study
o Genotoxicity / Mutagenicity Study

6. Quote the responsibilities of Regulatory affairs professionals.

Answer
o Ensuring that their companies comply with all of the regulations and laws
pertaining to their business.
o Working with federal, state and local regulatory agencies and personnel on
specific issues related to their business.
o Advising companies on the regulatory aspects and climate that would affect
their proposed activities.
o Keep in touch with international legislation, guidelines and customer
practices. Keep up to the date with a company’s product range.

7. Define ISO 14000.

Answer
• ISO 14001 is known as a generic management system standard, meaning that
it is relevant to any organization seeking to improve and manage resources
more effectively.

8. Write a short note on GLP.

Answer
Good Laboratory Practice
• GLP embodies a set of principles that provides a framework within which
laboratory studies are planned performed, monitored, and archived and
reported.

Purpose of GLPs:
• GLP is to certify that every step of the analysis is valid or Not.
• Assure the quality & integrity of data submitted to FDA in support of the safety
of regulated products.
• GLPs have heavy emphasis on data recording, record & specimen retention.

9. Define CDSCO.
Answer
• Central Drugs Standard Control Organization (CDSCO) exercises regulatory
control over the quality of drugs, cosmetics and notified medical devices in the
country. The CDSCO of India is main regulatory body for regulation of
pharmaceutical, medical devices and Clinical Trials.
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10. Define certificate of Pharmaceutical Product.

Answer
• The WHO Certification Scheme for a Certificate of Pharmaceutical Product
(COPP) is an international voluntary agreement to provide assurance to
countries participating in the Scheme, about the quality of pharmaceutical
products moving in international commerce.

SECTION B
LONG ANSWERS TYPE QUESTIONS (2 × 10 = 20)
1. What are SUPAC guidelines. Explain the SUPAC guidelines for immediate
release dosage form.
Answer
SUPAC Guidelines
• SUPAC represents the changes recommended by the US FDA at the time of scale
up or approval of NDA / ANDA.
• In the process of developing a new drug product, the batch sizes used in the
earliest human studies are small and the size of the batches is gradually increased
(Scale-up).
• The scale-up process and the changes made after approval in the composition,
manufacturing process, manufacturing equipment, and change of site have
become known as Scale-Up and Post approval Changes, or SUPAC.
The SUPAC Guidelines define
• The level of changes – Minor, Moderate and Major Changes.
• Test – Application test, in vitro dissolution and in vivo
• Filing – Annual report, changes being affected supplement and Prior
Approval Supplement.
• The level of changes may impact on formulation and quality performance in
following levels;
o Level 1: unlikely to have detectable Impact.
o Level 2: could have significant impact.
o Level 3: likely to have significant impact.

SUPAC guidelines for immediate release dosage form

• These guidelines provide recommendations for post approval changes in;
o The components or composition change,
o The site of manufacture change,
o The scale-up of manufacture change
o The manufacturing (process and equipment) change.

A) The components or composition changes:

• This section focuses on changes in excipients in the drug product.
• SUPAC-MR - Excipient critical or non-critical to the Modified drug release.
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o Changes in non-release and release controlling excipients.
• SUPAC-SS - Changes in preservative in semisolid formulations.
• SUPAC-IR Changes for immediate-release solid oral dosage forms.

B) The site changes of manufacture:

• Changes in the location of the site of manufacture, packaging operations
and/or analytical testinglaboratory.
• Do not include any scale-up changes, changes in manufacturing
(including process and/or equipment), or changes in components or
composition.
• Current Good Manufacturing Practice (CGMP) inspection.
Level I Level II Level III Changes
Changes Changes
Classification Single facility Same Different campus,
where the same continuous Different personnel.
equipment, campus,
standard Common
operating personnel, No
procedures other changes.
(SOP's),
environmental
conditions (e.g.,
Temperature
and humidity)
and controls,
and personnel
common.
Test Application/ o Application o Application/com
documentation compendia / pendial
requirements in compendial requirements.
chemistry, requireme o Notification of
dissolution and nts Location of new
in vivo o Notificatio site.
Bioequivalence n of o Updated batch
- None. Location of record.
newsite o SUPAC - IR:
o Updated Multi-point
batch dissolution
records profile in the
o SUPAC – application/com
MR - pendial medium.
Multi- o SUPAC - MR:
point Multi-point
dissolutio dissolution
n profiles profiles (15, 30,
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(15,30,45, 45, 60 and 120

60 and min) USP buffer
120 min) media at pH 4.5-
USP buffer 7.5 for extended
media at release). Three
pH 4.5-7.5 different Media
forextend (e.g., Water,
ed 0.1N HCl, and
release). USP buffer
o Three media at pH 4.5
different and 6.8 for
Media delayed
(e.g., release) until 80
Water, % of Drug
0.1N HCl, Released.
and USP
buffer
media at
pH 4.5 and
6.8 for
delayed
release)
until 80%
of Drug
Released.
Filing Annual report. Annual report. Annual report prior
documentation approval of
supplement.

C) Changes in Batch Size (Scale-Up/Scale-Down):

• Post-approval changes in the size of a batch from the pivotal/pilot scale bio
batch material to larger or smaller production batches call for submission of
additional information in the application.
• Scale-down below 100,000 dosage units is not covered by this guidance.
Level I Changes Level II Changes
Classification Change in batch size, up Changes in batch size
to and including a factor beyond a factor of ten
of 10 times the size of times the size of the pilot
thepilot/bio batch. or bio batch,No other
changes.
Test Updated batch records o Chemistry
documentation application/compendial Documentation
requirements stability.
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Application/ compendial
release requirements.
Notification of change and
submission of updated
batch records. Stability
testing: One batch with
three months accelerated
stability data and one
batch on long-term
stability.
o Dissolution
Documentation-Case B
testing.
o In Vivo Bioequivalence -
None.
Filing Annual report (long term Changes being effected
documentation stability data). supplement; annual report
(long-term stabilitydata).

D) Manufacturing Changes:
• Manufacturing changes may affect both equipment used in the
manufacturing process and theprocess itself.
• Equipment
Level I Changes Level II Changes
Classification Alternate equipment of Change to equipment of
the same design and different design and
principles as automated principle.
equipment.
Test Updated batch records, Updated batch records,
documentation Application/compendial Application/compendial
requirements and stability. requirements and stability.
SUPAC – IR - Multi-point
dissolution profiles in
multiple media.
SUPAC – MR - Multi-point
dissolution profiles in
multiple media.
Filing Prior approval Annual report and changes
documentation supplement with being Affected Supplement.
justification for change;
annual report(long-
term stability data).

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• Process
Level I Changes Level II Changes Level III Changes
Classification Alternate This category Changes in the
equipment of the includes process type of process
same design and changes including used (e.g. wet
principles as changes such as granulation to
automated mixing timesand direct
equipment. operating speeds compression).
outside of
application/
validation ranges.
Test Updated batch Updated batch Updated batch
documentation records, records, records,
Application/compe Application/comp
Application/com
ndial requirements endial
and stability. requirements and pendial
stability. requirements,
o SUPAC - IR - stability,bio-
Multi-point study and IVIVC.
dissolution o SUPAC - IR -
profile. Multi-point
o SUPAC- MR - dissolution
Multi-point profile.
dissolution o SUPAC- MR -
profiles in Multi-point
multiple media. dissolution
o SUPAC – SS - In profiles in
vitro release multiple
test media.
Documentation
.
Filing Annual report. Changes being Prior approval
documentation effected supplement
supplement; with
annual report justification;
(long term annual report
stabilitydata). (long-term
stability data).

2. Outline Quality risk management. Discuss the various risk management

tools and methodologies.
Answer
Quality Risk Management
Two primary principles of quality risk management are:

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• The evaluation of the risk to quality should be based on scientific knowledge and
ultimately link to the protection of the patient; and
• The level of effort, formality and documentation of the quality risk management
process should be commensurate with the level of risk.
• Quality risk management is a systematic process for the assessment, control,
communication and review of risks to the quality of the drug (medicinal) product
across the product lifecycle. A model for quality risk management.

Responsibilities
• Quality risk management activities are usually, but not always, undertaken by
interdisciplinary teams. When teams are formed, they should include experts
from the appropriate areas (e.g., quality unit, business development,
engineering, regulatory affairs, production operations, sales and marketing,
legal, statistics and clinical) in addition to individuals who are knowledgeable
about the quality risk management process.

Various risk Management tools and Methodologies

Initiating a Quality Risk Management Process
Quality risk management should include systematic processes designed to
coordinate, facilitate and improve science-based decision making with
respect to risk. Possible steps used to initiate and plan a quality risk
management process might include the following:
• Define the problem and/or risk question, including pertinent
assumptions identifying thepotential for risk;
• Assemble background information and/ or data on the
potential hazard, harm or humanhealth impact relevant to
the risk assessment;
• Identify a leader and necessary resources;

• Specify a timeline, deliverables and appropriate level of

decision making for the riskmanagement process.

Risk Assessment
• Risk assessment consists of the identification of hazards and the
analysis and evaluation of risks associated with exposure to
those hazards. Quality risk assessments begin with a well-
defined problem description or risk question.
• Three fundamental questions are often helpful:
• What might go wrong?
• What is the likelihood (probability) it will go wrong?
• What are the consequences (severity)?

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Risk Identification
• It is a systematic use of information to identify hazards referring
to the risk question or problem description. Information can
include historical data, theoretical analysis, informed opinions,
and the concerns of stakeholders.
• Risk identification addresses the “What might go wrong?”
question, including identifying the possible consequences.

Risk analysis
• Risk analysis is the estimation of the risk associated with the
identified hazards. It is thequalitative or quantitative process of
linking the likelihood of occurrence and severity of harms.

Risk Evaluation
• It compares the identified and analyzed risk against given risk
criteria. The output of a risk assessment is either a quantitative
estimate of risk or a qualitative description of a range of risk.
• When risk is expressed quantitatively, a numerical probability is
used.
• Alternatively, risk can be expressed using qualitative descriptors,
such as “high”, “medium”, or “low”, which should be defined in as

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much detail as possible.
Risk Control
• Risk control includes decision making to reduce and/or accept
risks. The purpose of risk control is to reduce the risk to an
acceptable level. Risk control might focus on the following
questions:
o Is the risk above an acceptable level?
o What can be done to reduce or eliminate risks?
o What is the appropriate balance among benefits, risks and resources?
o Are new risks introduced as a result of the identified risks being
controlled?
Risk Reduction
• Risk reduction focuses on processes for mitigation or avoidance
of quality risk when it exceeds a specified (acceptable) level.
• Risk reduction might include actions taken to mitigate the
severity and probability of harm. Processes that improve the
detectability of hazards and quality risks might also be used as
part of a risk control strategy.

Risk communication
• Risk communication is the sharing of information about risk and
risk management between the decision makers and others.
Parties can communicate at any stage of the risk management
process.
• The output/result of the quality risk management process should
be appropriately communicated and documented.

Risk review
• A mechanism to review or monitor events should be
implemented. The output/results of the risk management
process should be reviewed to take into account new knowledge
and experience.
• The frequency of any review should be based upon the level of
risk. Risk review might include reconsideration of risk
acceptance decisions.

Risk management methodology

• Quality risk management supports a scientific and practical
approach to decision-making. It provides documented,
transparent and reproducible methods to accomplish steps of
the quality risk management process based on current
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knowledge about assessing the probability, severity and
sometimes detectability of the risk.
• The pharmaceutical industry and regulators can access and
manage risk using recognized risk management tools and/or
internal procedures (e.g., standard operating procedures).
Below is a non-exhaustive list of some of these tools.
o Basic risk management facilitation methods (flowcharts, check sheets
etc.);
o Failure Mode Effects Analysis (FMEA);
o Failure Mode, Effects and Criticality Analysis (FMECA);
o Fault Tree Analysis (FTA);
o Hazard Analysis and Critical Control Points (HACCP);
o Hazard Operability Analysis (HAZOP);
o Preliminary Hazard Analysis (PHA);
o Risk ranking and filtering;
o Supporting statistical tools.

3. Explain
a. Total Quality management
Answer
• Total - made up of the whole
• Quality - degree of excellence a product or service provides
• Management - act, art, or manner of planning, controlling and
Directing. Therefore,TQM is the art of managing the whole to achieve
excellence.

Characteristics of TQM
• Committed management.
• Adopting and communicating about total quality management.
• Closer customer relations.
• Closer provider relations.
• Benchmarking.
• Increased training.
• Open organization
• Employee empowerment.
• Flexible production.
• Process improvements.
• Process measuring

Principles of TQM
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1. Produce quality work the first time and every time.
2. Focus on the customer.
3. Have a strategic approach to improvement.
4. Improve continuously.
5. Encourage mutual respect and teamwork

The Key elements of the TQM

• Focus on the customer.
• Employee involvement
• Continuous
improvement

b. Out of specification
Answer
• The term OOS (out of specification), is defined as those results of in
process or finished product testing, which falling out of specified limits,
that are mentioned in compendia,drug master file, or drug application.
• The OOS, may arise due to deviations in product manufacturing process,
errors in testingprocedure, or due to malfunctioning of analytical
equipment.
• The reasons for OOS can be classified as
1. Assignable
2. Non-Assignable.

Schematic Representation:

OOS (OUT OF SPECIFICATION) OCCURRED

ANALYST INFORM

QUALITY CONTROL MANAGER

INFORM QUALITY ASSURANCE MANAGER

TO ISSUE OOS FORM TO ANALYST

ANALYST DECIDES

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NON- ASSIGNABLE CAUSE ASSIGNABLE

CAUSE

c. Change control
Answer
• Change control is a systematic approach to managing all changes made
to a product or system.
• The purpose is to ensure that no unnecessary changes are made, that all
changes are documented, that services are not unnecessarily disrupted
and that resources are used efficiently.
Procedure
• The initiating department shall initiate the change as per the change
control format
• The initiating department shall furnish the details very clearly in the
form for present process/use, proposed change, Justification &
impact analysis and acceptance criteria.
• The initiating department shall also define changes as major or
minor based on productquality or its impact of safety, health, and
environmental aspects. Some of the major and minor changes are
listed below:
• Major Changes:
o For a substance of chemical and microbiological quality
evaluation.
o Addition or deletion of a step or addition of an alternative/new
step in the formulationmanufacturing process.

• Minor Changes:
o Change in the administrative references (name/company name,
address) of thecertificate holder.
o Change in the references (name/company name, address) of the
manufacturing site.
o Change or updating of the methods of analysis used to test the
substance.

d. ISO 9000 series

Answer
• ISO 9000: Explains fundamental quality concepts and provides
guidelines forthe selection and application of each standard.
• ISO 9001: Model for quality assurance in design, development,
production,installation, and servicing.
• ISO 9002: Model for quality assurance in the production and
installation ofmanufacturing systems.
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• ISO 9003: Quality assurance in final inspection and testing.
• ISO 9004: Guidelines for the applications of standards in quality
management andquality system.

SECTION C
SHORT ANSWERS TYPE QUESTIONS (5 × 7 = 35)
1. Describe the pilot plant scale-up considerations for solid dosage forms.
Answer
Pilot Plant Scale-up Consideration for Solid Dosage Forms
➢ The following points to be carefully consider during scaling up the solid
dosage forms;
• Batch size from intermediate to large scale production.
• Each stage of operation.
• Different types of equipment.
• Use of sophisticated instruments with larger volume load.
• Various sizes of equipment.

Material Handling:
➢ The handling of materials is quite different and necessary to handle
carefully in medium andlarge-scale production from the laboratory scale
(Mostly poured by hand or scooped).
➢ The characteristics of materials like density, size, shape and static charge
must be taken intoconsideration while adopting the processing steps like;
• Lifting and tilting of drums,
• Vacuum loading system,
• Screw feeding systems,
• Metering pump systems.

Chemical Weighing:
➢ The incorrect ingredients and quantities may lead to cross contamination
and misbrandedbrand during chemical weighing.
➢ A central weighing department should have for all the processing areas
due to followingadvantages;
• Centralization of responsibility,
• Avoidance of duplicating weighing facility,
• Lower labour cost.

Tablet blending and Granulation:

Blending and Granulation:
➢ Powders to be used for encapsulation or to be granulated must be well
blended to ensure gooddrug distribution.
➢ Inadequate blending at this stage could result in discrete portions of the
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batch being eitherhigh or low in potency to avoid drug content variation.
➢ Steps should also be taken to ensure that all the ingredients are free of.
➢ The lumps and agglomerates can be removed by doing screening or milling of
the ingredients should be done to avoid flow problems, non-reproducible
compression and encapsulation process, to facilitate content uniformity of the
product.
➢ In blending, segregation and mixing operation takes place which depends on
particle size, shape, hardness and density.

Dry Blending and Direct Compression:

➢ Different blenders used in blending are V- blender, double cone blender,
Ribbon blender, Slant cone blender, Bin blender, Orbiting screw blenders,
vertical and horizontal high intensitymixers.
➢ The factors affect the optimization of blending operation of directly
compressible materialsare;
• The order of addition of components to the blender.
• The mixing speed – Planetary type mixer, Tumbling Mixer, Cone Type
Mixer.
• The mixing time –It affects compressibility of Finished Material.
• The use of auxiliary dispersion equipment with the mixer – Use
chopper cell in Twin ShellMixer.
• The mixing action – Determined by the Mechanics of the Mixer.
• The blender loads Optimum working volume and normal working range.

Slugging (Dry Granulation):

➢ The dry powder cannot be compressed directly due to poor flow and
compression properties.
➢ The slugging is done by using the Tablet Press of 15 tonnes.
➢ After compression, slugs are broken down by Hammer Mill with suitable
particle sizedistribution.
➢ The granulation by dry compaction can also be achieved by passing
powders between tworoller which put pressure of 10 Tonnes per linear
inch.

Wet Granulation:
➢ The most common reasons given to justify granulating are;
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• To impart good flow properties to the material,

• To increase the apparent density of the powders,
• To change the particle size distribution,
• Uniform dispersion of active ingredients.
➢ Traditionally, wet granulation has been carried out using Sigma blade mixer
and Heavy-duty planetary mixer.

Drying:
➢ The most common conventional method of drying a granulation continues
to be thecirculating hot air oven, which is heated by either steam or
electricity.

➢ The important factors to consider as part of scale-up of an oven drying

operation are airflow,air temperature, and the depth of the granulation on
the trays.
➢ If the granulation bed is too deep or too dense, the drying process will be
inefficient, and if Drying times at specified temperatures and airflow rates
must be established for each product,and for each particular oven load.
➢ Fluidized bed dryers are an attractive alternative to the circulating hot air
ovens.

Reduction of Particle size:

➢ Compression factors that may be affected by the particle size distribution are
flowability, compressibility, uniformity of tablet weight, content uniformity,
tablet hardness, and tablet color uniformity.
➢ First step in this process is to determine the particle size distribution of
granulation using a series of “stacked” sieves of decreasing mesh openings.
➢ Particle size reduction of the dried granulation of production size batches
can be carried out by passing all the material through an oscillating
granulator, a hammer mill, a mechanical sieving device, or in some cases, a
screening device.

Facilities:
➢ To avoid cross contamination in scale up and to facilitate the cleaning of
equipmenteffectively, following facilities must be available that are;
• Presence of separate room with availability of more space,
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• Must have granulation as unit operation,

• Must have washing and drainage facilities,

Granulation Handling and Feed System:

➢ The handling of the finished granulation in the compression area is either by
Hand scooping for small scale or by sophisticated automated handling system
with vacuum or mechanical system for large scale.
➢ The properties of material like size, size distribution and flow property affects
the tablet properties like drug content uniformity, tablet weight, thickness
and hardness.

Tablet Compression:
➢ The tablet press performs following functions during the compression are;

• Filling of an empty die cavity with granulation.

• Pre-compression of granulation.
• Compression of granules.
• Ejection of the tablet from the die cavity and take-off of the compressed
tablet.
➢ The prolonged trial runs at press speeds is generally adopted to find out the
potential compression problems like sticking to the punch surface, tablet
hardness, capping, and weightvariation detected.
➢ High-speed tablet compression depends on the ability of the press to interact
with granulation.

Tablet Coating:
➢ Many changes in Sugar coating (Carried in conventional coating pans), due to
new developments in coating technology (Conventional sugar-coating pan
changed to perforated pans or fluidized-bed coating columns), changes in
safety and environmental regulations.

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➢ The development of new polymeric materials has resulted in a change from

aqueous sugar coating to aqueous film coating.
➢ The tablets must be sufficiently hard to withstand the tumbling to which they
are subjected in either the coating pan or the coating column.

2. Discuss the significance of space requirements and raw materials in

pilot plant set up.
Answer
Significance of Space requirements and raw materials in pilot plant set up
Space Requirements
The space required in pilot plant is divided into 4 areas that are as follows;
➢ Administration and information area:
• Adequate office and desk space should be provided for both scientists and
technicians.
• The space should be adjacent to the working area.
➢ Physical testing area:
• This area should provide permanent bench top space for routinely
used physical- testingequipment.
➢ Standard equipment and floor space:
• The sufficient specified space must be there for free installation,
operation and easymaintenance of the equipment.
➢ Storage area:
• Storage area for in process materials, finished bulk products, retained
samples, experimental production batches, packaging materials
(segregated into approved and unapproved areas).
• Controlled environment space allocated for storage of stability samples.
• Separate provisions for API and excipients further segregated into
approved andunapproved areas according to GMP.
Raw Materials
➢ One major responsibility of a Pilot plant is the approval and validation of
active and excipientraw materials used in the pharmaceutical products.
➢ This is because the raw materials used during the small-scale formulation
trials may not be representative of the large volume shipment of material
due to change in raw materials properties like particle size, shape,

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morphology, bulk density, static charges, rate of solubility,flow property and
colour.
➢ An alternative supplier must be arranged as stand by basis which must
validate the batches formanufactured products.

3. Explain various technology transfer agencies in India.

Answer
Technology Transfer Agencies in India
Asian and Pacific Centre for Transfer of Technology (APCTT)
• It is a United Nations Regional Institution under the Economic and Social
Commission for Asia and the Pacific (ESCAP) established in 1977 in Bangalore,
India.

• In 1993, the Centre moved to New Delhi, India. APCTT promotes transfer of
technology to and from small- and medium-scale enterprises (SMEs) in Asia and
the Pacific.
• APCTT implements development projects funded by international donors
aimed at strengthening the environment for technology transfer among SMEs.
• The objective of APCTT is to strengthen the technology transfer capabilities in
the region and to facilitate import/export of environmentally sound
technologies to/from the member countries.

National Research Development Corporation (NRDC)

• National Research Development Corporation (NRDC) was established in 1953
by the Government of India, with the primary objective to promote, develop
and commercialise the technologies / know-how / inventions / patents /
processes emanating from various national R&D institutions / Universities and
is presently working under the administrative control of the Dept.of Scientific
& Industrial Research, Ministry of Science & Technology.
• During the past six decade of its existence and in pursuance of its corporate
goals, NRDC has forged strong links with the scientific and industrial
community in India and abroad. It is recognized as a large repository of wide
range of technologies spread over almost all areas of industries, viz.

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Technology information, Forecasting and assessment Council (TIFAC)

• TIFAC is an autonomous organization set up in 1988 under the Department of
Science & Technology to look ahead in technology domain, assess the technology
trajectories, and support innovation by networked actions in selected areas of
national importance TIFAC embarked upon the major task of formulating a
Technology Vision for the country in various emerging technology areas.

• Under the leadership of Dr. APJ Abdul Kalam, Technology Vision 2020 exercise led
to set of 17 documents, including sixteen technology areas and one on services. In
more than 25 years of its service to the nation, it has delivered number of
technology assessment and foresight reports. While inaugurating the 103rd Indian
Science Congress in Mysuru, Hon’ble Prime Minister of India Shri Narendra Modi
released the Technology Vision 2035 prepared by TIFAC.This is being followed by
release of Technology Roadmaps in 12 thematic areas of national priorities and
importance.

Biotech Consortium India Limited (BCIL)

• Biotech Consortium India Limited (BCIL), New Delhi was incorporated as
public limited company in 1990 under The Companies Act, 1956.

• The consortium is promoted by the Department of Biotechnology, Government

of India and financed by the All India Financial Institutions and some corporate
sectors BCIL 's major functions include the development and transfer of
technology for the commercialisation of biotechnology products, project
consultancy, biosafety awareness and human resource development BCIL has
been successfully managing several Flagship schemes and Programmes of the
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Department of Biotechnology, Government of India.
• Most notable include Biotechnology Industry Partnership Programme,
Biotechnology Industrial Training Programme and Small Business Innovation
Research Initiative.

Technology Bureau for Small Enterprises (TBSE)/ Small Industries

Development Bank of India (SIDBI).
• The Technology Bureau for Small Enterprises (TBSE) is a platform
for MSMEs to tap opportunities at the global level for the
acquisition of technology or establishing business collaboration.
TBSE is a result of the cooperative initiative of the United Nations’
Asian and Pacific Centre for Transfer of Technology (APCTT) and
Small Industries Development Bank of India (SIDBI) in 1995.
• TBSE also receives partial funding from the Office of DC (SSI),
Government of India. Features of TBSE Offering a professionally
managed system for the reasons of technology and collaboration
exploration helping in the building up of confidence between
potential partner. It providing an opportunity to global
technology market through the process of networking.
• Taking up project appraisal and the preparation of a business
plan. The new technologies for the reason of transfer are sourced
from countries namely China, Philippines, South Korea, Australia,
Germany, as well as the U.S.

4. Outline validation and qualification. Write a short note on Analytical

Method Transfer.
Answer
Validation and Qualification
• Qualification and validation of facilities, equipment, systems and
procedures are essential to demonstrate that all critical stages of the
transfer project have been completed successfully, enabling the RU to
reproduce the product, process or method routinely to the specifications
agreed with the SU.
• Validation performed as part of the transfer project should be
documented in a validation master plan (VMP). The VMP should identify
the stages which need to be validated and define acceptance criteria.
• For intra-company transfers, the RU should operate under the same VMP
as the SU. For inter- company transfers, a VMP should be in place at the
RU before the transfer.
• The RU should prepare a validation protocol (VP) for each sequential
step. Successful execution of each VP should be documented in a
validation report (VR).
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• Setting up and commissioning of systems at the RU need to be

completed before qualificationand validation can be performed at the
RU. The steps required for this purpose have been described in this
guideline for buildings, services and equipment, manufacturing,
packaging and cleaning and analytical testing. In brief, the following
basic steps apply equally to each of these areas:
o the SU should provide information on materials, systems and
procedures involved in the manufacturing of the product, process
or method to be transferred;
o The RU should review the information provided by the SU, and
audit its current systems, equipment and processes, including
non-process related practices and support services that impact
the process;
• Once the required systems and procedures have been commissioned at
the RU, and successful training has been documented, qualification and
validation of facility and equipment should be executed, followed by
validation of analytical test methods, process validation for
manufacturing and packaging, and cleaning validation.
• The RU should review the gap analysis and prepare, where appropriate,
VPs for the facility, services and equipment.

Analytical Method Transfer

The analytical methods transfer protocol should cover the following sections:
• objective;
• scope;
• responsibilities of the SU and the RU;
• materials, methods and equipment;
• the experimental design and acceptance criteria;
• documentation (including information to be supplied with
the results, and report forms tobe used if any);
• deviations;
• references;
• signed approval; and
• details of reference samples (APIs, intermediates and finished
products). Successful transfer and validation of analytical methods
should be documented in a report.

5. Summarize Investigational Brochure. What do you understand by IND.

Answer
Investigational Brochure
• The Investigator’s Brochure (IB) is an important document, not only required as
a part of the IND but also prepared for presentation to potential clinical
investigators and ultimately for presentation to the investigator’s IRB
(Institutional Review Board or Independent Review Board).
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•The IB is a compilation of the clinical and nonclinical data on the investigational

product that is relevant to the study of the product in human subjects.
• Its purpose is to provide the investigators and others involved in the trial with
information to facilitate their understanding of the rationale for, and their
compliance with, many key features of the protocol, such as the dose, dose
frequency/interval, methods of administration, and safety monitoring
procedures.
• The IB should be reviewed at least annually and revised as necessary in
compliance with a sponsor’s writtenprocedures.
• Generally, the sponsor is responsible for ensuring that an up-to-date IB is made
available to the investigator(s), and the investigators are responsible for
providing the upto- date IB to the responsible IRBs.
• The following provides the information that should be included in the IB –
1. Title Page - This should provide the sponsor’s name, the identity of each
investigational product (i.e., research number, chemical or approved generic
name, and trade name(s) where legally permissible and desired by the
sponsor), and the release date. It is also suggested that an edition number
and a reference to thenumber and date of the edition it supersedes be
provided.
TITLE PAGE OF INVESTIGATOR’S BROCHURE (Example)
● Sponsor’s Name: Product: Research Number: Name(s): Chemical, Generic
(if approved)
● Trade Name(s) (if legally permissible and desired by the sponsor) Edition
Number:
● Release Date:
● Replaces Previous Edition Number:
● Date:
2. Confidentiality Statement - The sponsor may wish to include a statement
instructing the investigator/ recipients to treat the IB as a confidential
document for the sole information and use of the investigator’s teamand the
IRB/IEC.
3. Contents of the Investigator’s Brochure - The IB should contain the
following sections, each with literature references where appropriate:
1. Table of Contents
2. Summary
3. Introduction
4. Physical, Chemical, and Pharmaceutical Properties and Formulation
5. Nonclinical Studies
a. Nonclinical Pharmacology
b. Pharmacokinetics and Product Metabolism in Animals
c. Toxicology
6. Effects in Humans
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a. Pharmacokinetics and Product Metabolism in Humans
b. Safety and Efficacy
c. Marketing Experience
7. Summary of Data and Guidance for the Investigator
8. Publications
9. Reports (these references should be found at the end of each chapter.)
and Appendices (if any)

Investigational New Drug (IND)

• After the successful completion of preclinical research, Drug developer or
sponsor, must submit an Investigational New Drug (IND) application to
respective regulatory authority such as FDA in US,CDSCO in India etc in order
to start clinical research.
• The IND filing is the formal process by which a sponsor requests approval for
testing of a drug inhuman subjects.
• In the IND application, following things are must include:
o Animal study data and toxicity data
o Manufacturing information
o Clinical protocols (study plans) for studies to be conducted
o Data from any prior human research
o Information about the investigator
o Any additional data
• After submitting IND, respective regulatory authority reviewed all the data and
if satisfied, they grant the sponsor to begin clinical trial. It will take 30 -60 days
after IND submission to get approval for clinical trialfrom the FDA.

6. Describe Six sigma concepts.

Answer
• Six Sigma seeks to improve the quality of process outputs by identifying
and removing the causes of defects. Six Sigma approach is a collection of
managerial and statistical deficiencies in product. The concept of Variation
states “NO two items will be perfectly identical.
• In a process that has achieved six sigma capability, the variation is small
compared to the range of specification limit.
• A six-sigma process is one in which 99.9999966% of the products
manufactured are statistically expected to be free of defects (3.4 defects per
million).
• Six Sigma is a very clever way of branding and packaging many aspects of
Total Quality Management (TQM). (TQM is a management approach to long–
term success through customer satisfaction.)

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The Characteristics of Six Sigma:

➢ Statistical Quality Control: Six sigma is clearly derived from Greek
letter sigma which is used to denote standard deviation in statistics
which is used to measure nonconformance as far quality output is
concerned.
➢ Methodical Approach: The six sigma is not merely quality improvement
strategy in the theory as it features a well-defined methodical approach
of application in DMAIC and DMADV which can be used for quality
production.
➢ Fact and Data Based Approach: The statistical and methodical aspects
of Six Sigma show the scientific basis of the technique. This accentuates
an important aspect of Six Sigma that it is fact and data based.
➢ Project and Objective Based Focus: The Six Sigma process is
implemented for an organization’s project tailored to its specifications
and requirement. The process is flexed to suit the requirements and
conditions in which a project is operating to get the best results. Apart
from that, the Six Sigma is also objective based. The management needs
some incentive to invest in the Six Sigma process. It is aimed to enhance
profitability and to generate financial.
➢ The Customer Focus: The customer focus is fundamental to the Six
Sigma approach. The quality improvement and control standards are
based on the explicit customer requirements.
➢ Teamwork Approach to Quality Management: The Six Sigma process
requiresorganizations to get organized when it comes to controlling and
improving quality. Six Sigma involves a lot of training depending on the
role of an individual in the Quality Management team.

Six Sigma Objectives:

➢ Overall Business Improvement: Six Sigma methodology focuses on
business improvement. Beyond reducing the number of defects present
in any given number of products.
➢ Remedy Defects/Variability: Any business seeking improved numbers
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must reduce the number of defective products or services it produces.
Defective products can harm customer satisfaction levels.
➢ Reduce Costs: Reduced costs equal increased profits. A company
implementing Six Sigma principles must look to reduce costs wherever
it possibly can--without reducing quality.
➢ Improve Cycle Time: Any reduction in the amount of time it takes to
produce a product or perform a service means money saved, both in
maintenance costs and personnel wages.
➢ Increase Customer Satisfaction: Customer satisfaction depends upon
successful resolution of all Six Sigma’s other objectives. But customer
satisfaction is an objective all its own.

7. Explain the organization structure and responsibilities of CDSCO.

Answer
Organization Structure of CDSCO

Responsibilities of CDSCO
➢ CDSCO: For implementing and to revise the same as notified, from time
to time by theauthority.
➢ Initiate in framing of rules, regulations and guidance documents to
match the contemporaryissues in compliance with the requirements
of Drugs & Cosmetics Act 1940 and Rules 1945.
➢ Facilitate in Uniform implementation of the provisions of the Drugs
& Cosmetics Act 1940and Rules 1945.
➢ Function as Central license Approving Authority under the
provisions of Drugs andCosmetics Act 1940 and Rules 1945.
➢ Collaboration with other similar International agencies. • Providing
training to the Indianregulatory personnel.
➢ Approval of New Drugs
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➢ Clinical Trials in the country
➢ Laying down the standards for Drugs
➢ Control over the quality of imported Drugs
➢ Coordination of the activities of State Drug CO
➢ Providing expert advice with a view of bringing about the uniformity
in the enforcement ofthe Drugs and Cosmetics Act

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