FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Allergen identity and protein basis

OIT-002 / SOP v2.0

Allergen identity and protein basis

Pistachio (Pistacia vera) and peanut (Arachis hypogaea) raw materials, maintained in separate dossiers.

Download individual SOP · PDF

Procedure

  1. Qualify the specific source and material: species, nut fraction, processing, milling, defatting and additives. A trade name does not establish equivalence.
  2. Record lot, dates, conditions and possible other allergens. A roasting or supplier change is a critical change.
  3. Define with the analytical partner what the test measures: total protein, a specific allergen or another attribute. These quantities are not interchangeable.
  4. Assess method suitability for the matrix and processing. A nutrition panel or generic conversion factor does not establish this lot’s concentration.
  5. Set hygiene/microbiological and relevant contaminant specifications based on risk. Food-grade quality alone does not establish suitability for the intended therapeutic use.
  6. Release raw material only with reviewed evidence and complete linkage to finished batches. Retain a reference sample where the approved plan requires it.

Edition-specific detail

Declare the measurement basis as food mass, mg total protein or an identified analyte, with reference standard and matrix. For extract products assess the relevant protein profile and major allergens. Cross-species transfer needs specific scientific comparability; taxonomy or cross-sensitisation alone is insufficient.

Stop criterion

Unconfirmed species, unknown processing or insufficient critical protein data: quarantine.

Related forms

F-008

Sources and references

  1. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007, 2008Sections 2, 4.1.1, 4.2.4, 4.3, 4.4.3–4.4.5; pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-09-12
  2. Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Abstract and published guideline recommendations; DOI 10.1111/all.16345Specialist clinical recommendations; not stability evidence for local syrups or suspensions2026-09-12
  3. FDA — PALFORZIA prescribing informationUS prescribing information, July 2024 revision, accessed 2026-09-12Sections 1, 2.3, 4, 5 and 16Specific authorised product only; no equivalence with pharmacy-made peanut preparations2026-09-12
  4. 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