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.

1. 1
Documentation in Pharmaceutical Industry
Exploratory
Product Development Brief (EPDB)
Vanshika Gupta
1st sem M.Pharm (RA)
DRW (MRA102T)

2. CONTENT
• Introduction
 Document
 Drug substance
 Drug product
• Exploratory Product Development
Brief
 Goal
 Approach
2

3. 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

4. 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

5. Conti...
• Ensures documented evidence, traceability,
provide records and audit trail for investigation.
• Ensures availability of data for validation, review
and statistical analysis.
5

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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. 13
The three segments of exploratory
product development

14. 14
The iterative approach to exploratory
product development

15. 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

16. THANKYOU