SIKALIAS

Methodology & Evidence Hierarchy

How to assess, verify and document formulas from the bilingual compounding formulary.

Evidence hierarchy

  1. Current official pharmacopoeia or national formulary source.
  2. Recognised peer-reviewed stability and compatibility evidence.
  3. Product-specific analytical, microbiological and packaging data.
  4. Documented professional risk assessment where evidence remains incomplete.

Before adopting a formula

  • Confirm the patient, prescription and clinical intent.
  • Verify calculations, potency, solubility, pH, excipient compatibility and dosage-form suitability.
  • Qualify ingredients, packaging and equipment.
  • Define process controls, in-process checks and release requirements.
  • Establish a justified BUD and storage instruction.
  • Complete the master formula and individual compounding record.
Do not use a historical or dependency record as a current instruction without verification.