Quality by Design Drug Substance: Critical Quality Attributes made easy

Pharmaceutical Quality by Design has been widely discussed for over a decade. This video discusses a practical and pragmatic method for documenting the Critical Quality Attributes of small molecule drug substances. It is the starting point in Pharmaceutical Development and Quality Risk Management in the Pharmaceutical industry. Identifying Critical Quality Attributes of the drug substance was first discussed in ICH Q7 in late 2000. Later, CQA’s for drug product made their debut in ICH Q8. The word “critical” shows up 51 times in Q7 and 21 times in Q8. It became obvious that the industry would be talking about critical for the foreseeable future. Identifying critical variability was reinforced in ICHQ9. ICH Q12 made identifying impact variability on drug substance CQA’s central to the overall discussion. Understanding critical has a large impact on how the facility and equipment is qualified, the process is validated, and manufacturing is executed. The purpose of this series is to bring clarity to these requirements. It all starts with understanding the Critical Quality Attributes.
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