Module 18 2021

07/02/2021

Descriptions – e.g. containers and analytical methods

• Describe the container clearly and in detail, but don’t need technical drawings or lots of details • Pictures/photos are helpful for a reviewer • Avoid minor details that may change regularly (eg. …in a bottle with a red plastic cap) • Avoid providing the SOP, or internal method description. • Needs to be a summary of the method • Validation description should also be a summary, not a copy of the validation report. Could use a table format.

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Quick note on Module 3.2.P.2

• Pharmaceutical Development

• NOT part of the “registered” information • Describes how the product was designed and assessed • The formulation • The manufacturing process • Other key attributes that led to selection of the critical features (formulation/processes/controls) ● DESIGN DECISIONS – Investigations that worked and those that did not – Learnings from the data generated – Innovative approaches – Identification of critical parameters

“If you haven’t written it down, you haven’t done it”

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