Generic Drug Product Development Introduction

GENERIC DRUG PRODUCT
DEVELOPMENT
GENERIC DRUG
DEFINATION:
• A drug product that is essentially identical comparable

to brand/innovator drug in dosage form , strength ,
route of administration , quality and performance
characteristics , and intended use.
• It should contain the same active ingredients as the
original formulation.
When and How Generic Drug company come into play ?
Drug Development and Approval Process (Innovator Product)
Generic Approval Process
Generic Approval Process
Generic Drug ANDA Requirements
The generic drug manufacturer needs to
consider
• The lead time that is needed to make the product and
submission of an Abbreviated New Drug Application (ANDA) to
the U.S.FDA for approval.
• Moreover, there is a financial incentive to being the first
generic drug product filed and approved by FDA.
• 180-days exclusivity, is given under certain conditions, for the
generic manufacturer who is to file first.
• Formulation considerations for generic drugs include:
 The availability of raw materials, chemical purity, polymorphic
form.
 Particle size of the active pharmaceutical ingredient.
 Any patents that the innovator company has filed, including
patents for the synthesis of the active pharmaceutical
ingredient and composition of the dosage form
GENERIC DRUG APPROVAL PROCESS:
• The FDA’s office of Generic Drugs is responsible for
reviewing the ANDA and approving the drugs products
marketing.
• The FDA’s Office of Generic drugs has a website
http//www.fda.gov.org that provides additional information
for manufactures of generic drug products that includes flow
chart presentation of ANDA review process.
• And it also describes how FDA determines the quality,
safety, and efficacy of generic drug products prior to the
approval for marketing.
• Generic drug application reviewers focus on bioequivalence
data, chemistry and manufacture quality ,microbiology data
where relevant, requests for plant inspection, and drug
labeling information.
• The ANDA for generic drug product approval is based on bioequivalence
to the brand name product, appropriate chemistry and manufacturing
information, and appropriate labeling.
• Generic drug sponsors do not have to perform the nonclinical animal
toxicity studies or expensive clinical efficacy and safety studies that are
included in the new drug application.
• NDA which is submitted to the FDA for market approval of the brand
name drug product.
• The ANDA contains data which is then submitted to FDA’s Center for drug
evaluation and research for the generic drugs.
• FDA approved generic drugs must meet the same rigid standards as the
innovator drug.
• To obtain FDA approval, a generic drug product must- contain same active
ingredient as an approved drug product the inactive ingredients may vary.
• Be identical strength, dosage form ,route of administration, same
indications , bioequivalent, meet the batch requirements.
• The FDA’s Approved Drug Products with Therapeutic Equivalence
Evaluations and lists of the all approved products, both innovator and
generic are included in the orange book.
Generic Drug Product Development
PRODUCT: A product is something sold by an enterprise to its customers.

PRODUCT DEVELOPMENT: Product development is the set of activities
beginning with the perception of a market opportunity and ending in the production,
sale and delivery of a product.
THE PRODUCT DEVELOPMENT PROCESS
• A process is a sequences of steps that transforms a set of inputs into a set of
outputs
• A product development process is the sequence of steps or activities that an
enterprise employs to conceive , design , and commercialize a product.
• Some organizations define and follow a precise and detailed product
development process. While others may not even be able to describe their
processes
Generic Drug Product Development Cont’d…
THE PRODUCT DEVELOPMENT PROCESS

• We will consider here a generic product development that can be used in a
market pull- situation.
• The input of the process is a mission statement and the output of the process is
the product launch
MISSION STATEMENT: Identifies the target market for the product, provides a
basic functional description of the product, and specifies the business goals of the
effort; results from well executed product planning phase
PRODUCT LAUNCH: Occurs when the product becomes available for purchase
in the market place
Generic Drug Product Development Process
CONCEPT DEVELOPMENT
• The needs of the target market are identified, alternative product concepts are
generated and evaluated, and a single development is selected for further
Development
• A concept is the description of the form, function and features of a product
and is usually accompanied by a set of specifications, an analysis of
competitive products, and an economic justification of the project
SYSTEM – LEVEL DESIGN
• Includes the definition of the product architecture and the division of the
product into subsystems and components
• The final assembly scheme for the production system is usually defined during
this phase
• The output of this phase is usually a geometric layout of the product, a
functional specification of each of the products subsystems , and a preliminary
process flow diagram for the final assembly process
DETAIL DESIGN
• Includes the complete specification of the geometry, materials, and tolerance

of all the unique parts in the product and the identification of all the standard
parts to be purchased from suppliers.
• A process plan is established and tooling is designed for each part to be
fabricated within the production system
• The output of this phase is the control documentation for the product.
TESTING AND REFINEMENT
• Involves the construction and evaluation of multiple pre – production versions of the
product.
• Early prototypes are usually built with production intent parts [parts with the same
geometry and material properties as intended for the production version of the product
will work as designed and whether or not the product will work as designed and
whether or not the product satisfies the key customer needs
• Later prototypes are usually built with parts supplied by the intended production
process but may not be assembled using the intended final assembly process
• Later prototypes are extensively evaluated internally and are also typically tested by
customers in their own use environment
• The goal of the beta prototypes is usually to answer questions about performance and
reliability in order to identify necessary changes for the final product.
PRODUCTION RAMP - UP
• PRODUCTION RAMP UP –The purpose is to train the work force

and to work out any remaining problems in the production process.
• Ramp up is a term used in economics and business to describe an increase in
firm production ahead of anticipated increases in product demand.
• Alternatively, ramp up describes the period from completed initial product
development to maximum capacity utilization, characterized by product and
process experimentation and improvements.
• Ramp up in the first sense often occurs when a company strikes a deal with a
distributor, retailer, or producer, which will substantially increase product
demand.
THANK YOU

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GENERIC DRUG PRODUCT

• A drug product that is essentially identical comparable

PRODUCT: A product is something sold by an enterprise to its customers.

THE PRODUCT DEVELOPMENT PROCESS

• Includes the complete specification of the geometry, materials, and tolerance

• PRODUCTION RAMP UP –The purpose is to train the work force

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