Module 3 - Strategic case studies in practice

Pharmaceutical Development

Appendix 2. Illustrative Examples

A. Use of a risk assessment tool.

For example, a cross-functional team of experts could work together to develop an Ishikawa (fishbone) diagram that identifies potential variables which can have an impact on the desired quality attribute. The team could then rank the variables based on probability, severity, and detectability using failure mode effects analysis (FMEA) or similar tools based on prior knowledge and initial experimental data. Design of experiments or other experimental approaches could then be used to evaluate the impact of the higher ranked variables, to gain greater understanding of the process, and to develop a proper control strategy.

Ishikawa Diagram

Drying

Analytical

Temp

RH

Sampling

Air Flow

Method

Shock Cycle

Water Content Tablet

Drug Substance

Precompressing

Water

Main Compressing

Age

Temp/RH

Binder

P.S. Process Conditions

Operator

Feeder Speed

Temp

LOD

Press Speed

Training

Spray Rate

Diluents

Punch Penetration Depth

Spray Pattern

Tooling

P.S.

Plant Factors

Feed Frame

P.S.

Scrape Down

LOD

Other

Chopper Speed

Compressing

Lubricant Disintegrant

Mixer Speed

Raw Materials

Endpoint

Binder

Granulation

Power

Time

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