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PHARMACEUTICAL
DEVELOPMENT

CHAPTER I:

Product Development For

OSD Generic Medicines

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Market survey (IMS) and market value

Brand procurement
Literature search + patent search
Several lots (300 - 500 tablets or
capsules)

Define API (polymorph/salt, etc.)

Raw material source of supply
Identify source (+ alternate if possible)
Devise formulation strategies Samples (3 lots) + open DMF + order

Manufacturing and analytical equipment availability and procurement including necessary facilities
Tablet press, blenders, HPLC systems, low humidity rooms, containments suites, etc.

TO PAGE 2

FROM PAGE 1

Preliminary and preformulation studies

Raw material characterization

Physical and chemical Analytical method
Related substances/impurities
Stability indicating assay
Brand characterization Dissolution method development
Product pack description Residual solvents and OVI
Dissolution testing Cleansing method develop/validate

Trade dress decisions

Tooling order

TO PAGE 3

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FROM PAGE 2

Formulation development studies

Formulation development Packaging material specification

Pack development
Method of manufacture

Analytical method develop/validate

1. Related substances impurities
2. Assay
Prototype production and testing
3. In vitro test methods

Preliminary stability Prototype selection Drug product specifications

Range studies
Development pharmaceutics report

Raw material order

TO PAGE 4
5

FROM PAGE 3

Documents for exhibit batch manufacture

Master manufacturing documents Qualification protocol

Master packing documents Cleaning validation protocol

Stability protocol

TO PAGE 5

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FROM PAGE 4

Exhibit batch manufacture, randomization and packaging

Testing/release Bio samples packaging

Stability testing
3 months accelerated and actual time Report Bio assessment
point ongoing

Dossier compilation/submission
1. Data collation
2. Regulatory documents preparation
3. In-house data review
4. Submission

TO PAGE 6

FROM PAGE 5

Regulatory agency review

Approval to market

Scale-up and technical transfer Post-marketing surveillance

Commercial production
Pharmacovigilance
and validation

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REFERENCES/SOURCES

Chapter I:

Leon Shargel, I. K. (2014). Generic Drug Product Development: Solid Oral Dosage Forms, Second
Edition. Florida: CRS Press.