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Product Development Flowchart PDF

The document outlines a 21-stage process for developing oral solid dosage form generic drugs. It includes stages for literature searches, active ingredient sourcing and evaluation, purchasing innovator products for testing and reverse engineering, developing the formulation, optimizing the manufacturing process, conducting process validation, and submitting an Abbreviated New Drug Application (ANDA). The process aims to develop a generic drug that is bioequivalent to the innovator product and meets all regulatory requirements.

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Atikur Rahman Rony
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760 views2 pages

Product Development Flowchart PDF

The document outlines a 21-stage process for developing oral solid dosage form generic drugs. It includes stages for literature searches, active ingredient sourcing and evaluation, purchasing innovator products for testing and reverse engineering, developing the formulation, optimizing the manufacturing process, conducting process validation, and submitting an Abbreviated New Drug Application (ANDA). The process aims to develop a generic drug that is bioequivalent to the innovator product and meets all regulatory requirements.

Uploaded by

Atikur Rahman Rony
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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TABLETS ORAL D E V E L O P M E N T CHAPTER 2

PRODUCT DEVELOPMENT FLOWCHART


Solid, Dosage Forms

APPROVE
STAGE 1 a minimum of
LITERATURE TWO
SEARCH SUPPLIERS

STAGE 2
ACTIVE SOURCING
Q3A
Impurities cf.
STAGE 3 innovator's profile
Do not evaluate ACTIVE EVALUATION
material while still
in a R&D
STAGE 4
stage.
ACTIVE PURCHASING
USE ONLY
PRODUCTION
ACTIVES
STAGE 5
Active testing

STAGE 6
Innovator Product Purchasing

Purchase a new
STAGE 7
lot number every 3 months
Innovator Product Testing
from the smallest to the
largest pack size
(in each dosage strength)
STAGE 8
Bulk Active Testing

STAGE 9 Q3C - Residual


Solvents Check
DRUG Excipient Evaluation

DEVELOPMENT
21 STAGES STAGE 10
Container Closure
System Choices

STAGE 11
Manufacturing Process Evaluation

STAGE 12
Bulk Active Purchase

Handbook of Pharmaceutical Sect:2


2 . 13 Generic Development
TABLETS ORAL D E V E L O P M E N T CHAPTER 2

PRODUCT DEVELOPMENT
FLOWCHART
Solids Dosage Forms

STAGE 13
Analytical Evaluation

STAGE 14
Process Optimization
PO Batch

STAGE 15.
Prepare full Written SCALE - UP
Protocols for PO
Scale-Up & PQ STAGE 16
Batches PROCESS
(Future Q6A
QUALIFICATION
Requirements will impact
on this development)
STAGE 17
PIVOTAL BATCH
PRODUCTION

STAGE 18
ANDA PRE-SUBMISSION
AUDIT

Review all raw data


STAGE 19 Development & Lab Notebooks
ANDA SUBMISSION Evaluate all interim reports
that form part of the
Product Development Report
19B
PRODUCT
DEVELOPMENT
REPORT
STAGE 20
Process Validation &
Statistics
(3 commercial lots)
STAGE 21
Process Revalidation
after a major change
Process validation lots (Check SUPAC)
signify the first THREE
consecutive production
lots.
(Same Batch Size and
Active Lot No:)

Handbook of Pharmaceutical Sect:2


2 . 14 Generic Development

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