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OIT-002 · Allergen identity and protein basis

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

Template for local scientific review and approval. This is not an approved SOP of a specific laboratory.

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OIT-002 · 1.0 · 10.09.2026

Scope

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

Roles and prerequisites

Responsible pharmacist: approves implementation and release. Trained operator: performs and records work. Reviewer: verifies critical items. Specialist clinician/analytical partner: as specified.

Before implementation complete local document IDs, named roles, suitable equipment, specific specifications and acceptance criteria. Check the applicable framework in your country.

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.

Stop criterion

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

Related records

Sources

These sources inform the original editorial synthesis. Their publishers do not adopt or endorse this SOP.

Local approval

Local version: __________ Effective date: __________
Author: __________ Reviewer: __________ Pharmacist approval: __________
Signatures / dates: __________ Next review: __________