Documentation in Pharmaceutical Industry Part II

1. DOCUMENTATION IN
PHARMACEUTICAL INDUSTRY
PART-II
PRESENTED BY…..
MR. TARIF HUSSIAN
M.PHARM. (DRA)
GUIDED BY…..
DR. (MRS.) SANJU NANDA
PROFESSOR OF PHARMACEUTICS

2. CONTENTS
• Product Development Plan (PDP)
• PRODUCT DEVELOPMENT REPORT
(PDR)
• CERTIFICATE OF ANALYSIS (CoA)

3. PRODUCT DEVELOPMENT PLAN
(PDP)
• PRODUCT DEVELOPMENT is a set of
activities starting with the perception of a
market opportunity and ending with the
sale of a product.
• Product Development Lifecycle (PDLC)
encompasses every phase of a product,
from the idea to retirement.

5. BASIC
RESEARC
H
• PROVIDE BACKGROUND ON MARKET • PRODUCT
POTENTIAL
CLINICAL
STUDY
• RECOMMEND DEVELOPMENT • DEFINE PRODUCT
PROFILE NEEDS • DEFINE COMPETITORS •
DEVELOP MARKET • DEVELOP STRATEGY
REGULATO
RY
APPROVAL
• INPUT ON PRODUCT LABELING • RECOMMEND
FILING STRATEGY • DEFINE LAUNCH PLAN •
DEVELOP POSITIONING AND BRANDING
PRODUCT
LAUNCH
• FINALIZE STRATEGY • FINALIZE PRICING • FINALIZE
PROMOTION AND BRANDING • IMPLEMENT LAUNCH
CAMPAIGN • FINALIZE FIELD SALES PLANS
• Monitor performance • Adjust strategy and tactics •
Sequence promotion • Manage product life cyclePost launch
Marketing
Product

6. SUMMARY OF THE DEVELOPMENT STRATEGY
TARGET PRODUCT PROFILE
MARKET ASSESSMENT
NONCLINICAL OVERVIEW
CLINICAL DEVELOPMENT STRATEGY
REGULATORY STRATEGY
INTELLECTUAL PROPERTY (IP)
MANUFACTURING STRATEGY
LIFECYCLE MANAGEMENT PLAN
BACK-UP AND FOLLOW-UP COMPOUNDS

7. PRODUCT DEVELOPMENT
REPORT (PDR)
• INTRODUCTION
 Background information, objectives, scope and limitations, relevance of the study,
research questions and thesis structure.
• COMPANY PRESENTATION
(Due sensitive information is not displayed in online version)
 Introduction, operations, company strategy and competitors
• THEORETICAL FRAMEWORK
 Product launch process, Stage-Gate model, Idea generation, scoping and building
business case, development, testing and validation, launch and launching strategy
• FINDINGS AND DISCUSSIONS
 Interview analyse and review of company current launch process, compering the
theoretical review and current activity.
• PRODUCT LAUNCH PROCESS
 Presentation of Launch stage as a separate process (sales and marketing), presentation of
finalized product launch process for Company X (from idea to launch), reliability and validity of
the study, own professional development and learning.
• REFERENCES AND APPENDIX

8. CERTIFICATE OF ANALYSIS (CoA)
• Document is meant to serve as a guide for the preparation
and appropriate use of a Certificate of Analysis (COA) for
Bulk Pharmaceutical Excipients (BPE).
• Certificates of analysis (CoAs) are a tangible, and
important, manifestation of a manufacturer’s
relationship with its suppliers of APIs, excipients, and
the other materials used to make drug products.
• Provided by suppliers to customers as a matter of
course, these documents operate at the point where
materials, laboratory control systems, and
manufacturing intersect.

9. GENERAL GUIDANCE FOR
(CoA)
• Differentiation of Excipient Manufacture
• Preparation and Appropriate Use of a Certificate of
Analysis
• Use of Contract Facilities
DISTRIBUTOR INFORMATION
• General Guidance
• Original Manufacturer and Manufacturing Site
• Certificate of Analysis Data
• USE OF ELECTRONIC SIGNATURES