Module 5 Presentations

05/07/2024

Quality Module Headings - Placebo

Placebo Module P.1 - Description and Composition P.2 - Pharmaceutical development P.3 - Manufacture P.4 - Control of excipients P.5 - Control of Placebo P.7 - Container Closure System P.8 - Stability

Comments • Drug product module only with abbreviated headings (see guideline) • Cross referring possible (e.g. if manufacturing process same minus addition of active) • Limited data (e.g. batch analysis, stability) may be acceptable

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Stability Protocol

• Stability protocol advised in guideline, reduce maintenance burden • Stability protocol: – Covers the maximum planned shelf-life (i.e. 24 months shelf-life claim requires 24 months testing in the protocol) – Frequency of testing (normally per ICH) – Analytical procedures/specifications applied – Plans for extension and any proposed extrapolation plans – Statement that in the event of a significant trend the sponsor will inform the competent authority • Statement confirming intention to proceed with extension as per described protocol unless

NCE Stability Protocol & Extrapolation

Stability Available

Extrapolation Permitted

Limit

<6 months 6 months

Up to 4x

Up to 12 months only

Up to +12 months

+12 months max

Other scheme? Possible – justify in application

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