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Agency official: Q1/Q2 sameness, pH adjusters, ophthalmic deviations require careful justification
Summary
The presenter said deviations in Q1/Q2 sameness, inactive ingredient limits, or differences in pH adjusters (for injectables, ophthalmics, OTIX) can be major deficiencies and may require waiver requests and supporting documentation rather than BE waivers.
Discussing drug-product composition the official warned that using inactive ingredients above database limits without justification or failing Q1/Q2 sameness requirements can be major deficiencies. For ophthalmic and injectable products, the presenter reiterated that deviations meeting regulatory exceptions still should satisfy PSG recommendations and may require in vivo BE studies.
The speaker singled out pH adjusters as non-exception excipients for injectables, ophthalmics, and OTIX and said differences from the RLD require a specific waiver plus supporting documentation rather than a BE waiver. He advised applicants to refer to the guidance that explains the waiver request process and documentation requirements.
