process of development of drug product

1. GENERIC DRUGS
PRODUCT
DEVELOPMENT
AHMED TAHA
M.PHARM 1ST SEM
DEPT. PHARMACEUTICS AL AMEEN COLLEGE OF PHARMACY
SUBMITTEDTO :Mrs. TANUSHREE CHAKRABORTY

2. CONTENT
• Introduction.
• When generic drugs marketed.
• Examples.
• Difference between new branded and generic drug development requirements .
• A generic drug product development process .
• References .

3. GENERIC DRUG
• A drug product that is comparable to brand /innovator drug in :
• Dosage form
• Strength
• Route of administration
• Performance characteristics and intended use .
• Also it should contain same active ingredient as the original formulation .

4. GENERIC DRUGS IN USA AND INDIA
• USA :
MONOPLY IS GIVENTO PATENT HOLDER FOR THE NEW DRUG .
• INDIA :
There were not patent laws till 2005 led to anyone to replicate any drug in India without
legal ramifications
Led to 99.5% of generic branded share .

5. GENERIC DRUGSVS BRANDED DRUGS

6. WHEN GENERIC DRUG MARKETED ?
• A patent and exclusivity protection ends .
• Patent owner waives its rights .
• FDA requirements are met .

9. DIFFERENCE BETWEEN NEW BRANDED AND GENERIC
DRUG DEVELOPMENT REQUIREMENTS
BRAND NAME DRUG NDA
REQUIREMENTS
GENERIC DRUGS ANDA
REQUIREMENTS
1. Labeling Labeling
2. Pharma Pharma
3. Chemistry Chemistry
4 . Manufacturing Manufacturing
5. Controls Controls
6. Microbiology Microbiology
7.Testing Testing
8.Animal studies Bioequivalence
9 . Clinical studies
10 .bioavailability

10. A GENERIC DRUG PRODUCT DEVELOPMENT
PROCESS :
MISSION
STAATMENT
PRODCT
PLANNING
CONCEPT
DEVELOPMENT
SYSTEM
SYSTEM LEVEL
DESIGN
TESTING AND
REFINEMENT
DETAIL
DESIGN
PRODUCTION
RAMP UP
PRODUCT
LAUNCH

11. PRODUCT PLANNING
ITS AFFECTED BY MARKET PULL –SITUATION .

12. MISSION STATEMENT
• IdentifiesTheTargeted Market For the product.
• Provides a basic functional description of the product .
• Specifies the business goal of the effort.
• Results from well executed product planning phase.

13. CONCEPT DEVELOPMENT SYSTEM
• The needs of market are identified .
• Alternative product concepts are generated and evaluated .
• Single development is selected for further development .
• A concept is the description of the :
• Function and features of products .
• Set of specifications and analysis of competitive products .
• An economic justification of the project .

14. SYSTEM –LEVEL DESIGN
• Includes the definition of the product architecture and division of the product into
subsystems and components .
• The final assembly scheme for the production system is usually during this phase .
• The output of this phase usually :
• A geometry layout of the product
• A functional specification of each of the products subsystems
• Preliminary process flow diagram for the final assembly process .

15. DETAIL DESIGN
• Complete specification of the geometry ,materials , and tolerance of all the unique parts
in the product
• 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.

16. TESTING AND REFINEMENT
• The construction and evaluation of multiple pre-production versions of the product.
• Early prototypes are usually bult with production intent parts .
• Later prototypes are usually bult with parts supplied by the intended production process
but may not be assembled using the intended final assembly process .

17. TESTING AND REFINEMENT
• Later prototypes are extensively evaluated internally and typically tested by customer in
their own use environment .
• The goal of the beta prototypes is usually to answer questions about performance and
reliability to Identify necessary changes for final product.

18. PRODUCTION RAMP UP
• Ramp up often occurs when a company strikes a deal with a distributor , retailer or
producer , which will substantially increase product demand .

19. REFERENCES
• https://www.scirp.org/journal/paperinformation?paperid=112370
• https://www.slideshare.net/SachinG19/generic-drugs-product-development-176738668
• https://www.uspharmacist.com/article/generic-drugs-in-the-pipeline-2018-update
• https://www.uspharmacist.com/article/dispelling-generic-drug-myths-and-misconceptions

20. THE END