Q 1 ) What is pilot plant and scale – up 2] Dry blending –

Explain in detail about the scale – up • Powders used for granulation must be
technique for solid dosage form well blended to good drug distribution.
Ans • Ingredients should be lumps free
I) Pilot plants - • Equipment – V blender , double cone
• Plant is Place where 5M like money, man, blender
machine , materiel and method brought
together for manufacturing of product 3] Granulation -
• In which lab scale formula transfer into • Increased density of powders
large scale formula to increase production • Change the particle size distribution
• Operate general information of system • Use - Sigma blade mixer
• Standardization of formulae 4] Binders –
• Used in tablet formulation to make more
II) scale up – compressible
• Designing the data of pilot plant model • Provide mechanical strength to the tablet
• Finding the mistakes on small scale • Example – dry Binders , solution binders
• And make profit on large scale
5] Drying –
III) Scale – up Technique for solid dosage • Granules is circulating hot air oven ,
form heated by steam or electricity
• Solid dosage form – includes tablets , • Important factor – airflow , air temp. &
capsules , & powders Depth of granulation
• Removing the presence of solvents (
A) Pilot plant scale - up for tablets :- water or other liquid)
• Manufacturing area should be cleaned
regularly 6] Reduction of particles size –
• Controlling microbial contamination • Compressibility , uniformity of tablet
• Area should be air – conditioned & weight
humidity controlled • Particle size distribution
• Tablet hardness
#_ Tablet production – • Sieves decreasing

1] Material handling systems – 7] Compression –

• Used to transfer material for more than • Compression of granules
one products • On high speed tablet press machine
• Avoid cross contamination • Weight variation detected
• Deliver the accurate amount of
ingredients to the destination 8] Tablet coating –
• Maintenance and cleanliness a) sugar coating
b) film coating
c) Enteric coating
Q.2) Technology transfer protocols following WHO guidelines.
Ans:-
I) Technology Transfer:- The movement of data, designs, inventions, materials,
software, technical knowledge or trade secrets from one organisation to another or
from one purpose to another.

II) Technology Transfer Protocols:- The technology transfer protocols are the protocols
which are use and important in technology Transfer process.

III) Simple Format Of Technology Transfer Protocols

1. Cover Page
2. Table Of Content
a. Technology Transfer Protocol approval
b. Purpose
c. Objectives
d. Scope
e. Key personnel & their Responsibilities
f. Technology Transfer process

IV) Technology Transfer Protocols

• Parallel comparison Of materials, methods & equipment
• Identification Of critical control points
• The Transfer stages with documented evidence that each critical stages has bees
satisfactorily Accomplished before the next commences
• Experimental design & acceptance criteria for analytical methods
• Information on trial production batches, qualification batches & process validation
• Changes control for any process deviations encountered
• Assessment Of end product
• Arrangements for keeping retention samples Of Active ingredients, intermediate &
finished products,
• Information on reference substances where applicable, & conclusion including
signed approval by project manager.
Q 3) SUPAC Guidelines
Ans – a) Components or composition
I) Introduction – change:-
• SUPAC – Scale up post approval
changes 1) level 1 change –
• changes made after approval in the
• Test documentation
composition , manufacturing process ,
equipment and changes of site is - Chemistry documentation
known as SUPAC - Dissolution documentation
• Filling documentation
II) Classification of SUPAC guidelines –
- Annual report
1) Level of changes
✓minor change
2) Level 2 change –
✓moderate change
✓major change
• Test documentation
✓Annual reports - Chemistry documentation
✓ prior approval supplement - Level 1 + batch with 3 month
2) Test documentation stability
Application • Dissolution documentation
in vitro dissolution
- Case A – High permeability,
in vivo test
High solubility
III) The FDA issued various guidelines – - Case B – low permeability ,
high solubility
A) SUPAC – IR :- - Case C – high permeability, low
• ( for immediate release ; tablets , capsule) solubility drugs
B) SUPAC – MR :-
• in vivo test
• ( for Modified release ; solid oral dosage
form )
C) SUPAC – SS :- 3) Level 3 changes –
• ( for non – sterile semisolid ; creams , gel , • Test documentation
lotion) - Chemistry documentation level
1 + 1month stability
A] SUPAC – IR –
- Dissolution documentation –
a) Components or composition change case B
b) site change • filling documentation –
c) change in batch size - Annual report
d) manufacturing change - Prior approval supplement
 b) Site change – d) Manufacturing changes
• change in location of site , manufacturing • Change in equipment or process
facilities
1) level 1 change
1) level 1changes • non automated to automated
• site changes – environmental conditions , • mixing & operating speed
equipment , sop
• Test documents – chemistry 2) level 2 change
documentation , dissolution compendia • Test & documentation as per level 1
• Filling the – Annual report • outside and inside application

2) Level 2 changes – 3) level 3 Change

• site change – campus or facilities in city • process of mixing and manufacturing
blocks • documentation as per level 3
• Test documentation – level 1 + one batch
long term stability
• filling documentation – Annual report

3) level 3 changes –
• site change to different campus
• Test documentation – chemistry
documentation
• filling documentation – annual report

c) Change in batch size –

• Post approval change

1) level 1 change
• change in batch size
• same design & principal
• Test & filling documentation are same

2) level 2 changes
• change in batch size Beyond factor 10
• Test documentation – level 1 + one batch
+ case B
Q.4) Platform Technology Q.5) Quality Risk Management (QRM)
Ans:- AND:-
I) platform technology:- I) Introduction
• a common or standard method, equipment, • Risk:- is define as combination of the
procedure or work practice that may be applied
probability of occurrence of harm is
across multiple products under development or
manufacture known as risk
• It is valuable tool to improve efficiency and quality • Management :- include planning,
in drug Product development organizing, directing controlling an
• Platform enables a continuous improvement by Organization
adding data for every new molecule developed by • Quality Risk Management :- is a
this approach, increasing the strength of the
Systematic process for the assessment
platform
control, communication and review of
II) Following are some examples of platform risk of the quality of product
technologies :- • QRM:- is one of the most important
A) Effervescent technology Task in pharmaceutical industry
B) Inhalational technology • Because the industry produces
C) Liposomal technology
D) Microsphere technology
medicines whose quality is directly
E) Nanotechnology related to patients health
A) Effervescent technology:-
• This technology is used to manufacture fat II) General QRM process
dissolving effervescent tablets A)responsibilities
• QRM activities are usually but not always
B) Inhalational technology:-
• The technology is applied to treat respiratory tract
undertaken by in disciplinary team
diseases, and includes MDIs (Metered Dose • When teams are form they should include
Inhalers), DPIs (Dry Powder Inhalers), Auto inhaler appropriate areas
and nasal sprays B) Initiating a QRM process
• It improves science based decision for risk
C) Liposomal technology:-
management
• This technology is used to improve delivery of
drugs, to reduce the toxicity of drugs and to • Define the problem and risk questions
optimize pharmacokinetic parameters and • Background information for human
pharmacological effect health
• Specify a timeline
D) Microsphere technology:-
C) Risk Assessment
• The technology is applied to develop
differentiated formulations for targeted delivery • It use for identification of hazards
and offers various advantages like reducing side • define problems or risk question
effects and the need to take repeated injections • Risks assessment contains
✓ Risk identification
E) Nanotechnology:- ✓ Risk analysis
• The technology applied in the development and ✓ Risk evaluation
manufacturing of various drugs like paclitaxel,
D) Risk control
fenofibrate, sirolimus, etc.
E) risk communication
Q. 6) Technology transfer and Who V) Who Guidelines for Technology Transfer
1) Qualifications and Validation
Guidelines for technology Transfer 2) Organization and management
3) Production
I) Technology Transfer 4) Packaging
• Technology Transfer is process of transfer 5) Cleaning
of manufacturing process…from one 6) Premises
manufacturing unit to another 7) Equipment
manufacturing unit 8) Documentation
• This process is required for 1) Qualification and Validation
- Successful drug discovery • Qualification and validation determined
- Products development on the basic of risk management
- Clinical research principles
- Full scale commercialization 2) Organization and management
• Transfer Of Data • All technology transfer activities should
- Research to production department be planned
of Same company • All necessary activities should be
- Between two different companies identified , organized and documented
3) Production
II) Importance of Technology • SU and RU should jointly prepare
• To introduce safe and effective medicinal technology transfer
product in the market • The information should be transfer
• Control epidemic and pandemic situations about….Raw materials, API, Excipients
• Maintain competitive in market 4) Packaging
• Information about packaging to be
III) Team of Technology Transfer transfer include
1) Process technologists :- Design, packing, processing & labelling
2) QA representatives 5) Cleaning
3) QC representative • Sending unit provide information about
4) Production representatives cleaning to reduce cross contamination
5) Engineering representatives 6) Premises
• SU provides information about layout ,
IV) Technology Transfer Process construction and design to the RU
7) Equipment
• SU provide List of equipment and
instrument involved in production filling ,
packaging and QC testing
8) Documentation
• The transfer of document by technology
transfer included master plan, protocol,
name and address of SU and RU
Q.7) Write Note on Technology transfer agencies in India
Ans:- I) Introduction
• It’s a process by which basic science research and fundamental discoveries are
developed into practical
• To achieve success in Hi-tech area, synergy between science and technology
development in first requisite
• An organic linkage between laboratory developing technology and industry receiving
technology are in second requisite
• In India technology transfer from public funded research institute to industry in various
ways
• The research organization have special cell for liaison between research organization
and industry
II) disputes on technology transfer
• Disputes relating payment of royalty and fees
• Delay in completion of the project
• Passing of unapproved technology
• After sales service and backup
• Intellectual property rights (IPR) issue like trade mark
• Quality and cost of production
• Delay supply of components
III) Role of technology transfer in economic development
• Increase in physical stock of innovative resources
A)Further exploitation of economical resources
• Natural resources
• Manpower
• Innovation
• Physical resources
B) productivity increase
• Labour
• Capital
• Natural resources
• Innovation capacity
IV) various agencies involved in TOT In India
• Indian space research organization ( ISRO)
• Defence research and development organization (DRDO)
• Foundation of innovative and technology transfer Delhi (FITT)
• Sponsored research and industrial consultancy(SRIC) Kharagpur
• Asian and Pacific Centre for transfer of technology
• Small industries and development bank of India ( SIDBI)
Q. 8) Steps involved in Technology 4) Step 4 :- Assessment and Marketing
• Once application filed, assessment of the
Transfer R and D to production technology will be done
Ans:-
• Then we can use vital details of
#_Steps involved in Technology Transfer
assessment for marketing

5) Step 5 :- Licensing the Patent

• The goal of university is put the invention
to public hands
• The invention transfer to the industry
through various licensing arrangement

6) Step 6 :- Commercialization
• The process of bringing new products or
services to market.
1) Step 1 :- Invention Disclosure
• Production, distribution, marketing, sales,
• Researchers submit disclosure of
and customer support is done
invention which Describe invention
- Name of the inventor
- public disclosures
- publications
- and other information.
• Then set up the meeting with researcher
and discuss invention

2) Step 2:- Evaluation

• The office evaluate invention disclosure
for its Patentability and commercial value
• Then decided that invention is applicable
for patent or not

3) Step 3:- Patent Application

• If the invention is passed evaluation then
it is applicable for patient
• And fill the form for patent
• Time require to issue patent is 4 to 6
years
• And expire in 20 years from the Date of
filling
Q 9) Explain Regulatory affairs , responsibilities of regulatory affairs
and department of regulatory affairs
Ans -
I) Regulatory affairs –
• Also called as government affairs.
• Profession within regulated industries like pharmaceutical , medical devices , energy &
banking.
• Mixture of science and management.
• Important goals drug - development organization.
• Responsible for obtaining approval for new pharmaceutical products

II) Responsibilities –
• Protect public health
• Controlling the safety and efficacy of products
• Obtaining approval for new pharmaceutical products
• Approval is maintained for as long as
• Arrange consultation and meetings
• Collecting scientific data
• Preparing submission , clinical affairs or quality assurance

III) Regulatory affairs department –

• Obtaining approval for new pharmaceutical products
• Approval is maintained for as long as
• Profession within regulated industries
• Touch with international legislation , guidelines
• Generating scientific data & requirements
• Impart training to R & D , pilot plants and RA

IV) Regulatory authorities –

1. India :- central drug standard control organization (CDSCO)
2. USA :- Food and drug administration (FDA)
3. Canada :- Health Canada
Q. 10) Enlist Various Approved bodies Q.11) write a detailed note on quality
and agencies related to Drug management system
Development and technology transfer, Ans:-
I) Quality Management System
Explain Any one (5mark)
• The Quality Management System (QMS) is
Ans:-
a formalized system that documents
• Regulatory Agencies and organization
processes and procedures, and assigns
play important role in drug
roles, responsibilities and accountabilities
development process in country
for achieving established quality
• Drug Regulation Required to ensure
objectives, and effective and efficient
Safety, efficacy and quality of Drug
quality management
• To insure the Accurate and appropriate
drug information is available to public II) Benefits of QMS
• Every country has its own regulatory
• Provide better quality of products and
authority
services
#_ Various approved bodies and agencies
• Enhance customer satisfaction
related to drug development and Technology
• market expansion
transfer
III) QMS improve Quality by
1) USFDA – USA
• Producing the consistent results
2) MHRA – UK
• preventing mistakes
3) CDSCO – India
4) TGA – Australia • Reducing costs
5) Health Canada – Canada
6) WHO.. IV) Scope of pharmaceutical QMS:-
A) Pharmaceutical development :-
#_WHO • drug substance development
• Who is specialized agency of the United • formulation development
Nations • Manufacture of investigational
• Responsible for international public health Product
• Work for maintain universal health • Delivery system development
• Monitoring public health risk • Analytical method development
• Collect Data on global health issues B) Technology Transfer:-
• New product transfers during
# Role of WHO development through
• Provide technical support manufacturing
• Monitor health situation • Transfers within or both
manufacturing & testing sites for
• Articulating Ethical and evidence based
marketed Product
policy options
C) Commercial manufacturing :-
• Monitor vital events like birth ,death
• Acquisition control of materials
,wedding etc.
• Quality control & assurance
Q. 12) IND ( Investigational New 3) Investigator Information
• Qualifications of Clinical investigator
Drug Application )
• Qualifications of Professionals
Ans:-
I) IND
4) Clinical Protocols
• IND is request for authorization from FDA
• Major part of IND
to administer an investigational drug to
• Detailed protocol for purpose of Clinical
humans
studies to avoid unnecessary risk
• IND is application filed to FDA for clinical
trials in Human
5) Other Commitments
• IND application provide High Quality
• to obtain review of the study by an
preclinical Data
institutional review board (IRB)
• Almost 85% Drugs are subjected to
clinical trials
IV) Phase Of Human testing For
• Through IND pharmaceutical company
Investigational Drugs
obtain permission to start human clinical
trials
1) Phase 1:-
• About 20 to 80 healthy volunteer are
II) Types of INDs
monitored
1) Investigator INDs
• Establish drug safety and profile
2) Emergency Use INDs
• This take about 1 year
3) Treatment INDs
• Also contain safety, metabolism, Excretion
4) Commercial INDs
5) Screenings INDs of drug

2) Phase 2 :-
III) Mandatory Information in INDs
• 100 to 300 patients volunteer monitored
1) Animal pharmacology and toxicology • Drug effectiveness in those with specific
studies condition or disease
• Preclinical Data Permit that product is • This take about 2 year
safe for initial testing in human • Groups of similar patients receive actual
• Also included previous experience with drug or other drug to know their effect
drug in human • Safety and side effects are review

2) Manufacturing Information 3) Phase 3 :-

• Manufacturing information containing • Usually several thousand patients are
- Composition monitored
- Manufacturers • Perform in clinics and hospital
- Stability • Different types and age ranges patients
• This information help in manufacturing of are evaluated
product
Q . 13) NDA (New Drug Application) B) Index
Ans:- • It is table of content
I) NDA • Helpful to find content of Application
• NDA is application which submitted by
manufacturer of Drug to the FDA C) Application Summary
• New Drug Application can be only fill • The summary should contain all aspect of
when drug substance pass through all application
three clinical trials • Summary discuss about
• NDA includes 1) Labeling
1) All human and animal Data 2) Scientific Rational, intended use
2) Data Analysis 3) Foreign marketing history
3) Pharmacokinetic of Drug 4) Non clinical pharmacology
4) Manufacturing and proposed labeling 5) Pharmacokinetics
• Preclinical and clinical reports and risk 6) Bioavailability
benefit are review 7) Microbiology
• Approval of NDA granted within 2 years
• However, it will take 2 month to several D) chemistry , Manufacturing control
years • First technical section of NDA is chemistry
section
II) Goal of NDA • It contain Information about composition,
• The NDA provide enough information to manufacture and specifications of Drug
permit FDA reviewer to reach safety,
efficacy and quality for pharmaceutical E) Clinical Data
production • Section of clinical Data includes
1) The clinical pharmacology section
III) Content Of NDA 2) List of Investigator
3) List of IND
A) Administrative Items 4) List of NDA
1) Application Form 5) Controlled clinical trials section
• Each applicant is required to submit 6) Uncontrolled clinical trials section
signed from FDA 365h 7) Other studies and information section
• Which is published by FDA 8) summary of effectiveness data
• Contains information about sponsor 9) Summary of safety information
2) Patent Information 10) Drug over dosage information
• Require patent information to be
submitted with the NDA IV) Submission of Data
3) Financial Certification 1) Archival copy 2) Review copy
• NDA must contain all financial details and • Submission of electronic Submission
agreements provide many advantage to the applicants
as well as review team
Q. 14) Clinical Research, Clinical research C) Parts of Clinical research Protocol
Protocol and role of Biostatistics in 1) Introduction
pharmaceutical product department 2) Abstract
Ans:- 3) Objective
I) Clinical Research 4) Background
• Research in which study of people and 5) Study Rational
their body parts to understand disease 6) Eligibility Criteria
and health is called as Clinical Research 7) Study Design
• Clinical research is medical research 8) Criteria for Evaluation
involving people 9) Study Treatment
• Two types 10) Clinical Assessment
1) Observational studies 11) Clinical Laboratory measurements
2) Clinical trials 12) Evaluation by visit
• Aim of clinical research is evaluation in 13) Protocol Violation
medical and surgical process 14) Statistical Section
• Carried out by component persons 15) Publication
• Have goal Of Increasing medical
III) Biostatistics in Pharmaceutical product
knowledge
department
• Branch of statistics concerned with
II) Clinical Research Protocols
mathematical facts and data related to
• complete written description of
biological events.
scientific rational for research on human
• Biostatistics covers
- Health
A) Aim Of Clinical research protocol
- Medicine
• To clarify the research question,
- Genetics
• To clarify ethical considerations - Biology
• To formulate a hypothesis and - Nutrition
objectives, A) Branches of Biostatistics
• To apply for funding, 1) Descriptive Biostatistics
• To decide about a study design, 2) Inferential Biostatistics
• To compile existing knowledge,
B) Application Of Biostatistics
B)Component involved in clinical • In physiology and Anatomy
Research Protocol • In pharmacology
• Institutional review board (IRB) • In Medicine
• Healthcare professionals • Modern Medicine
• Policy makers, • Environmental science:
• Systematic reviewers • Preventive Medicine
• Clinical realists, • Biotechnology
• Participants • Clinical Medicine
• Founder’s
Q. 15) Six Sigma Concept Q. 16) Out Of Specifications
Ans:- Ans:-
I) Six Sigma Concept I) OOS
• Six sigma is set of management tools and • OOS is defined as a result that falls
technique design to improve outside the predetermined specifications
manufacturing output by reducing the or established acceptance criteria set by
likelihood of error the manufacturer and the laboratory.
• The term OOS test results includes all
II) Key Features of Six Sigma suspect results that fall outside the
• Six sigma multidimensional structured predetermined Specification
approach
- Improving process II) OOS may be Observed During the
- Lowering Defects analysis of
- Reducing process variability • Stability study
- Reducing costs • Finish API
- Increasing customer satisfaction • Intermediates
- Increase profits • In process
• Raw Materials
III) Benefits Of six sigma • Packing Material
• Generates sustained success
• Sets a performance goal for everyone III) Reason Of OOS
• Enhances value to customers
• Accelerates the rate of improvement A) Laboratory
• Promotes learning and cross-pollination • Method of Analysis
• Executes strategic change • Use of Non Calibrated Instruments
• Error in calculations
IV) Core Principles In Six • Analyst error
• Always focus on the customer • Instrument failures
• Understand how work really happens
• Make the processes flow smoothly B) Process Related
• Reduce waste and concentrate on value • Operator Error
Stop defects through removing variation • Equipment Failure
• Get buy-in from the team through • Quality of Raw materials
collaboration • In process control during manufacturing
• Make efforts systematic and scientific • Deviation from the validated procedure

V) Key Elements C) Sample Homogeneity

• Customer • Sampling error
• Processes • Handling samples
• Employees • Pooling of sample
Q.17) ISO 9000 Q.18) ISO 14000
Ans:-
I) ISO 9000 I) ISO 14000
• ISO 9000 is a set of internationally recognized • ISO 14000 is a family of standards related
standards for quality assurance and management
II) Purpose of ISO 9000
to environment management that exists
• To sell in the European Union market to help organizations.
• To compete in domestic markets
• To improve the quality system II) Features
• To improve subcontractors’ performance • better environment management
• flexible and applicable to all nations
III) Elements Of ISO 9000
• scientific
1) Management responsibility
• practice and useful
• To define, document, implement a policy for
quality.
2) Quality system: III) Object
• To establish, document, and maintain a quality • Minimize operations which harm to
system which includes a quality manual, system environment
procedures, and quality planning. • comply with applicable laws and
3) Contract review: regulation
• To establish and maintain documented • Continue improve in the above
procedures for contract review
4) Document and Data control
IV) ISO 14000 Entails five aspects
• To establish and maintain document procedures
to control all documents and Data as standard 1) Environmental Management System
5)Design control 2) Environmental Auditing and related
• To establish and maintain documented investigations
procedures to control and verify the design of the 3) Environmental Labels and Declarations
product to ensure conformance to specified 4) Environmental Performance Evaluation
requirements. 5) Life Cycle Analysis & Terms and
III) Benefit of ISO 9000
Definitions
• ISO 9000 continues work on improvement
- Improve control V) Benefits Of ISO 14000
- Improve discipline • Cost savings in waste, recycling and
- Improve procedure consumption
- Improve Documentation • Management of environmental risks
- Customer satisfaction • Can reduce insurance cover costs

IV) Disadvantages VI) Elements Of ISO 14000

• Not all countries accept ISO registrars
1) Environmental policy
• Mainly for exporting firms
2) Planning
• Barrier to trade
3) Implementation
• Time consuming
• Costly
4) Management review
5) Continuous improvement
Q. 19) Explains Total Quality 3) Packaging
management (TQM) • packaging processes should be defined
Ans:- and controlled
I) Total Quality Management • ensure that correct materials are packed
• labels should be durable
• Total Quality Management is defined as a
• labels must provide correct information
customer-oriented process and aims for
continuous improvement of business
operations. 4) Facilities and Equipment
• common goals of TQM is • The location, design, and construction of
- Improve product quality buildings should be suitable for
- Improve service quality manufacturing
• Equipment should be clean and
- Improve production process
- Improve manufacturing process
5) Sterile area
- Improve process of rendering of
• the sterile area was free form
services.
contamination
• Smoking, eating, drinking, avoid in
II) Advantages of TQM Production areas
1 Improves reputation, faults and problems
2 Higher qualified employees 6) Labelling
3 Lower cost • label should be clean clear and durable
4 Decrease waste • label should contain sufficient information
5 Fewer defective products
6 Quality control inspector 7) Computerised System
• Computer systems should be designed To
III) Disadvantages Of TQM store data
• Initial introduction cost
• Benefit may not be seen for several years V) Elements of TQM
• Workers may be resistant to change
1) Management Commitments to Quality
IV) Importance of TQM in Pharma Industry 2) Customer Satisfaction
3) Measurement of Quality
1) Handling 4) Continuous improvement:
5) Training
• open the container carefully
6) Corrective action for root cause
• open container by approved manner 7) Recognition of High Quality
2) Storage 8) Involvement of Employees
• store product in air tights containers
• storage area must be clean
• storage materials should be best quality
Q.20) Write a detailed note on QBD Q. 21) ICH Guidelines
Ans:- Ans:-
I) Quality By Design :- I) ICH Guidelines
• A systematic approach to development A) ICH stands for International Council For
that begins with predefined objectives Harmonization.
and emphasizes product and process B) It’s for the technical requirements for
understanding and process control, based pharmaceutical for human use
on sound science and quality risk C) Unique in bringing together the regulatory
management authorities and pharmaceutical industry.
• Quality by design is emerging the D) Ensure that safe, effective, high quality
Assurance of safe , effective drug supply medicines are developed
to the customers
• Also offers promise to significantly
II) They are categorized into 4 types.
improve manufacturing quality
performance.
A) Quality
II) QBD model consists following steps.. • Relating to chemical and pharmaceutical
1) Establish the project design targets and Quality assurance
goals • Q1A Stability
2) Define the market and customers that will • Q2 Analytical validation
be targeted • Q3A Impurities
3) Discover the market , customers, and • Q4 Pharmacopoeias
societal needs
4) Developed the feature of the new design B) Safety
that will meet the needs • Relating to in vitro and in vivo pre-clinical
5) Develop or redevelop the processes to studies.
produce the feature • Toxicity Testing
III) Elements of QBD.. • Reproductive Toxicology
1) Quality target products profile and define • Biotechnology Products
critical quality attributes • Pharmacology Studies
2) Product design and understanding &
identification of critical material attributes C) Efficacy
3) Design and implement a control strategy • Relating to clinical studies in human
4) Manage products life cycle including subject.
continues improvement • Good clinical Practice
• Clinical safety
IV) Advantages of QBD
D) Multidisciplinary
• Better understanding of the process .
• Less batch failure • Cross-cutting topics which do not fit
uniquely into one of the above categories.
• Return on investment / cost saving
Q. 22) write short note types and scope of COPP ( 5 Marks )
Ans:-
I) COPP
• COPP stands for Certificate of Pharmaceutical Products.
• This certificate is strictly recommended by the World Health Organization (WHO)
• It is mandatory for the countries importing goods or medicines
• It was first developed in 1975.
• Since then it has been revised in 1988, 1992and in 1997.

II) Types of COPP

1) WHO 1975 type COPP

2) WHO 1988 type COPP
3) WHO 1992 type COPP

III) Scope of COPP

• COPP allow to manufacturing company to sell there products

• COPP demonstrate question about safety quality efficacy of medicine to allow
marketing
• It also demonstrate that it follows correct guidelines of GMP
• Increase level of quality and safety of product
• COPP is needed when product is intended for regeneration or its renewal
• Certification can be recommended By WHO to maintain quality of product
Q. 23) Explain in details about structure and function of CDSCO
( 10 Mark)
Ans:- I) CDSCO
• CDSCO stands for Central Drugs Standard Control Organisation
• It is National Drug Regulatory Authority of Government of India.
• CDSCO has control on the
- quality of drugs, cosmetics
- medical devices in the country.
• It is works under the Drugs and Cosmetics Act.

II) Structure CDSCO

III) Function of CDSCO
1) Approval of new drugs and clinical trials.
2) Import Registration and Licensing.
3) Licensing of Blood banks, LVPS, Vaccines, Pie-DNA products etc.
4) Amendment to D and C Act and Rules.
5) Banning of drugs and cosmetics.
6) Grant to Test license, Personal License, NOC’S for export.
7) Testing of drugs by Central Labs.
8) Publication of Indian Pharmacopoeia.
9) Monitoring adverse drug reactions.
10) Guidance on a technical matter.
Q. 24) write Short Note on organization and Responsibilities of SLA ( 5 Mark)
Ans:-
I) SLA
• SLA stands for State licensing Authority
• authority created for the purpose of regulating & controlling the licensing of:-
- cultivation manufacture,
- distribution and sale of medical marijuana in the state.

II) Structure of SLA

III) Function of State Licensing Authorities

• Licensing of drug manufacturing
• Licensing of sales establishments
• Licensing of drug testing laboratories.
• Approval of drug formulations for manufacture.
• Monitoring of quality of Drugs & Cosmetics
• Administrative actions.
• Pre- and post- licensing inspection
• Recall of sub-standard drugs.
IV) Responsibilities of State Authority
• licensing for Manufacturing of drugs
• Approving drug formulations for manufacture
• Carrying out pre- and post-licensing inspections
• Overseeing the manufacturing process for drugs
• Licensing for sale and distribution of drugs
• Recall of substandard drug
Q.25) Write a Note in Regulatory requirements & approval procedure
for new drugs
Ans:-
A) Regulatory requirements:-
• Currently different countries follow different Regulatory requirements for approval for
new drugs.
• In India following Regulatory requirements approved for new Drugs.

1. Drug Discovery:- Drugs undergo laboratory and animal testing to answer basic questions
about safety. Drugs are tested on people to make sure they are safe and effective.

2. Drug Development & Manufacturing:- The process of bringing a new pharmaceutical

drug to the market

3. Clinical Trials on Humans:- Clinical trials are research studies performed in people that
are aimed at evaluating a medical, surgical, or behavioural intervention.

4. Marketing Application:- An application, submitted to a Regulatory Authority in any

jurisdiction, Commercialize a product as a drug.

B) New Drug approval procedure:-

• A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists
reviews the company's data and proposed labeling. If this independent and unbiased
review establishes that a drug's health benefits outweigh its known risks, the drug is
approved for sale.
• Schedule Y deals with import, manufacture & obtaining Marketing approval for new
drug in India.
• Rule 122 A- Application FIR permission to import new Drug
• Rule 122 B- Application for permission to manufacture new Drug
• Rule 122 D- Application for permission to import/manufacture FDC
• Rule 122 DA- Application for permission to conduct clinical trails
• Rule 122 E- Definition Of new drugs
• New substance having therapeutic indication
• Fixed dose combination
• Considered new drug for 4 years from date Of First approval.
1) Pilot Plant Scale up for Solid Dosage form
2) Technology Transfer Protocols
3) SUPAC
4) Platform technology
5) QRM (Quality Risk Management)
6) Technology Transfer and WHO Guidelines
7) Technology Transfer Agencies in India
8) Steps Involved in Technology Transfer
9) Regulatory Affairs

10) Various Approved Bodies and Agencies of

Technology Transfer

11) Quality Management System

12) IND ( Investigational New Drug)
13) NDA (New Drug Application)
14) Clinical Research, Biostatistics
15) Six sigma Concept
16) OOS ( Out of Specifications )
17) ISO 9000
18) ISO 14000
19) TQM ( Total Quality Management)
20) QBD (Quality By Design)
21) ICH Guidelines
22) COPP
23) CDSCO
24) SLA