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