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EPDB - Exploratory Product Development Breif

The document outlines the importance of documentation in the pharmaceutical industry, emphasizing good documentation practices to ensure accuracy, traceability, and compliance with regulatory standards. It discusses the definitions of drug substance and drug product, and critiques traditional phased-and-gated product development processes for being slow and inflexible. The document proposes an exploratory product development approach aimed at reducing uncertainty and risk through an adaptive system that responds to changing market and technology conditions.

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Risk Evaluation• Regulatory Affairs• Drug Development•
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1 Documentation in Pharmaceutical Industry Exploratory Product Development Brief (EPDB) Vanshika Gupta 1st sem M.Pharm (RA) DRW (MRA102T)
CONTENT • Introduction  Document  Drug substance  Drug product • Exploratory Product Development Brief  Goal  Approach 2
INTRODUCTION DOCUMENT • A DOCUMENT is a piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record. WHY DOCUMENTATION • Documents and products are produced in pharmaceuticals but regulatory bodies are interested to see documents first. • Due to the importance given to documentation in pharma "good documentation practices" is required. 3
Conti... • Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents. • Clearly written documents prevent errors of various activities in Pharma. PURPOSE OF DOCUMENTATION: • Defines specifications and procedures for all materials and methods of manufacture and control. • Ensures that all personnel knows what to do and when to do it. • Ensure that authorized persons have all information necessary for release of product. 4
Conti... • Ensures documented evidence, traceability, provide records and audit trail for investigation. • Ensures availability of data for validation, review and statistical analysis. 5
Conti... Drug substance : • Drug substance is an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient. 6
Conti... Drug product : • Drug product is a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. 7
Exploratory Product Development Brief • Many companies today utilize some form of a traditional phased-and-gated product development process, which originated more than 50 years ago. It hasn’t changed substantially since then. • A phased-and-gated system creates multiple batches that slows down the overall speed of a product development project. 8
Conti... • When companies try to maintain a traditional phased- and-gated process in a changing environment, the product development team is unable to manage to the scope, timeline and budget approved at the outset. • The result usually includes changing product requirements, unexpected problems, rework, schedule delays, breaking the budget and commercial failure. 9
GOAL • Develop Exploratory PD® (ExPD), which help companies achieve growth and improve product development success through an adaptive system. • The primary goal of ExPD is to reduce uncertainty and risk by reducing the unknown. • When organizations adapt quickly to the changing environment (market, technology, regulations, globalization, etc.), they reduce uncertainty and risk leading to product success. 10
APPROACH • The product development team needs an approach that allows them to adapt to change in customer needs, markets, competition, technology and more. • ExPD proposes a new approach to developing products, using a two-pronged solution: 1) Treating product development from a comprehensive systems perspective, and 2) Fundamentally reworking the development process to focus on lowering project risks and uncertainties 11
Conti... • It is an adaptive approach that responds quickly to changes in internal and external factors. • This process helps project teams identify, evaluate, and prioritize uncertainties and risks throughout a project. • It then helps the team determine how and when to resolve the uncertainty or when it is appropriate to kill a project. 12
13 The three segments of exploratory product development
14 The iterative approach to exploratory product development
REFERENCE 1. Maitreyi Zaveri, Documentation in pharma industry 2. A Textbook of Pharmaceutical Quality assurance by Mr. Sanjay A. Nagdev, Mr. Mayur R. Bhurat, Dr. Md. Rageeb Md. Usman Dr. Krishna R. Gupta, Dr. Upendra B. Gandagule 3. https://www.exploratorypd.com/ 4. https://en.everybodywiki.com/Exploratory_prod uct_development 5. https://www.exploratorypd.com/pitfalls-of-the- phased-and-gated-process/ 15
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