TABLETS ORAL D E V E L O P M E N TD E V E L O P M E N T CHAPTER 2

HHandbook of PPharmaceutical Sect:22. 13 GGeneric DDevelopment

PRODUCT DEVELOPMENT FLOWCHARTSolid, Dosage Forms

STAGE 1LITERATURE

SEARCH

STAGE 2ACTIVE SOURCING

STAGE 3ACTIVE EVALUATION

STAGE 4ACTIVE PURCHASING

STAGE 5Active testing

STAGE 6Innovator Product Purchasing

STAGE 7Innovator Product Testing

STAGE 8Bulk Active Testing

STAGE 9Excipient Evaluation

STAGE 10Container Closure

System Choices

STAGE 11Manufacturing Process Evaluation

STAGE 12Bulk Active Purchase

APPROVEa minimum of

TWOSUPPLIERS

Do not evaluate material while still

in a R&Dstage.

USE ONLYPRODUCTION

ACTIVES

Purchase a newlot number every 3 months

from the smallest to thelargest pack size

(in each dosage strength)

DRUGDEVELOPMENT

21 STAGES

Q3C - ResidualSolvents Check

Q3AImpurities cf.

innovator's profile

TABLETS ORAL D E V E L O P M E N TD E V E L O P M E N T CHAPTER 2

HHandbook of PPharmaceutical Sect:22. 14 GGeneric DDevelopment

PRODUCT DEVELOPMENT FLOWCHART

Solids Dosage Forms

STAGE 13Analytical Evaluation

STAGE 14Process Optimization

PO Batch

STAGE 15.

SCALE - UP

STAGE 16PROCESS

QUALIFICATION

STAGE 17PIVOTAL BATCH

PRODUCTION

STAGE 18ANDA PRE-SUBMISSION

AUDIT

STAGE 19ANDA SUBMISSION

STAGE 20Process Validation &

Statistics(3 commercial lots)

STAGE 21Process Revalidationafter a major change

(Check SUPAC)

19BPRODUCT

DEVELOPMENTREPORT

Process validation lotssignify the first THREEconsecutive production

lots.(Same Batch Size and

Active Lot No:)

Review all raw dataDevelopment & Lab Notebooks

Evaluate all interim reportsthat form part of the

Product Development Report

Prepare full WrittenProtocols for POScale-Up & PQ

Batches(Future Q6A

Requirements will impacton this development)