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SOP-019 / 2.1

Microbiological quality and preservative effectiveness

Nonsterile forms and preservation studies in the exact final matrix.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.1Record editorial review date: 2026-10-14

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Procedure

  1. Define route, population, formula, pH, preservation and packaging. Select applicable full compendial methods and limits with the analytical laboratory.
  2. Distinguish enumeration/specified-organism testing from preservative-effectiveness testing. Passing the former does not establish the latter.
  3. Verify method suitability in the matrix, organism recovery and preservative neutralisation/removal. Failed recovery is not reported as absence of microorganisms.
  4. Link challenge testing to complete preservative concentrations, container material and use conditions. A supplier report for another base requires documented applicability.
  5. For BUD extension assess chemical, physical and microbiological evidence together. Record sampling times, results and predefined criteria in F-013.
  6. Specification failure requires quarantine, investigation and review of shared materials/water/equipment. Do not repeat testing merely until a passing result appears.

Additional detail

For an aqueous extension beyond USP default 14/35-day limits, the selected framework requires suitable <51> antimicrobial-effectiveness testing together with a stability-indicating study. Preservation verification covers formula and container/closure system or suitable bracketing; it is not a per-batch test. Enumeration/specified-organism tests do not replace <51>.

Stop criterion

Invalid method or failed critical microbiological criterion: no release.

Related forms

F-005, F-006, F-013

Sources and references

  1. 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 certification2026-10-14
  2. 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 guidance2026-10-14
  3. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007; adopted 20 November 2008; effective 20 May 2009; remains current effective quality version on EMASections 2, 4.1.1, 4.2.4.4, 4.4.3–4.4.5; document pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-10-14
  4. USP — General Chapter <795> FAQsUpdated 1 November 2023; retrieved 14 October 2026Questions 52–66, especially 52, 54–56, 58–59, 61–64Publisher interpretation: optional formula-specific aw testing, initiation-date BUD, stock-component exceptions, exact-formula stability studies and antimicrobial-effectiveness testing. Not Greek law.2026-10-14