FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Semisolids, emulsions and gels

SOP-010 / SOP v2.0

Semisolids, emulsions and gels

Non-sterile cutaneous forms; other routes require separate suitability assessment.

Download individual SOP · PDF

Procedure

  1. Verify base identity, emulsion type and compatibility of active, pH and preservative. Do not assume commercial bases are interchangeable.
  2. Define required comminution, wetting or dissolution. Choose compatible aids without arbitrarily adding a new excipient.
  3. Follow the phase temperatures and addition sequence of the specific method. Record actual thermal history.
  4. Define mixing and cooling to control heterogeneity, air entrapment or destabilisation. Equipment changes require assessment.
  5. Check appearance, agglomerates, separation, yield and, where required, pH/rheology/assay using suitable methods.
  6. Fill a compatible container and check net quantity and closure. Assess the effect of jar versus tube use on BUD.

Edition-specific detail

Record emulsion type, phase order, actual phase temperatures and cooling profile. Rpm without impeller geometry and volume does not establish process transfer. Report a diluted-sample pH together with its dilution; do not present it as direct pH of an anhydrous ointment or external oil phase.

Stop criterion

Incompatibility, irreversible separation or unknown base: no release.

Related forms

F-003, F-005, F-006

Sources and references

  1. NAPRA — Model Standards for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 4–9Risk, personnel, facilities and QA; its historical BUD table is not used for current USP defaults2026-09-12
  2. NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-09-12
  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