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SOP-020 / SOP v1.0

Stability-study applicability and BUD extension

Acceptance of published or commissioned studies for an exact monograph.

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Procedure

  1. Identify the full study, authors, version, DOI/URL and corrections. An abstract or promotional claim is insufficient for complete method appraisal.
  2. Compare active/salt, concentration, starting product, all excipients/preservatives, process, container/closure and temperature. Record every difference and its relevance.
  3. Determine whether the assay separates API from degradation products and whether recovery suits the matrix. Assess physical attributes and dose delivery, not only percentage API.
  4. For aqueous extension assess required microbiological evidence, preservation and actual opening conditions. Explicitly state missing relevant data.
  5. Set the maximum supported period only within the applicable framework. The public USP implementation allows up to 180 days with a suitable study; a specific USP–NF monograph is assessed in its full current text. No general Greek legal applicability is asserted.
  6. The reviewer approves F-013 and transfers period, temperature and restrictions to F-006 and the label. Changing a critical feature prevents automatic reuse of the decision.
Stop criterion

Unresolved critical mismatch or inadequate study: no extension beyond an applicable default.

Related forms

F-013, F-006

Sources and references

  1. Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic regulatory checklist, accessed 2026-09-12pp. 15–16; USP <795> sections 10.1–10.5Temperature conditions and requirements for supported extension; jurisdiction-specific guidance2026-09-12
  2. USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
  3. PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12