Document control and local adoption
Every SOP, monograph, master record and form used in the laboratory.
Stasinos Chr. Sikalias · The science of compounding
Pharmacy laboratory quality system
Procedures connecting evidence, practice and a verifiable outcome.
Template for local scientific review and approval. This is not an approved SOP of a specific laboratory.
16 general procedures and 8 dedicated to allergens. Each SOP includes roles, six steps, a stop criterion, records and references. Product-dependent numerical limits belong in the local master record.
General laboratory procedures
PDF · GR/EN
Request and risk assessment
Before accepting a new preparation or material change. This does not validate sterile compounding.
Training, hygiene and clothing
Staff, visitors and contractors entering the compounding area.
Suppliers, receipt and raw materials
Active substances, excipients, commercial products and packaging materials.
Facility, cleaning and line clearance
Non-sterile compounding area and shared equipment.
Equipment, calibration and maintenance
Balances, thermometers, pH meters, mixers and volumetric equipment.
Calculations and weighing
Batch calculations, units, potency corrections and weighing records.
Master formulation and batch record
Converting a bibliographic monograph into a controlled local master record.
Oral solutions, syrups and suspensions
Non-sterile oral liquids under a specifically approved master record.
Semisolids, emulsions and gels
Non-sterile cutaneous forms; other routes require separate suitability assessment.
Powders and hard capsules
Non-sterile solid forms with controlled uniformity and exposure.
Packaging, labelling and handover
Every finished preparation and its safe-use instructions.
Sampling, QC and release
In-process and finished-product checks before supply.
Stability and BUD justification
Assigning a use period for the exact formula, packaging and conditions.
Deviations, CAPA, complaints and recall
Errors, near misses and problems identified after supply.
External testing, data and change control
Analytical partners, digital records and quality-system changes.
Allergen-specific procedures
Allergist interface and order verification
Laboratory support for individual allergen preparations. This is neither a treatment protocol nor manufacturing authorisation.
Allergen identity and protein basis
Pistachio (Pistacia vera) and peanut (Arachis hypogaea) raw materials, maintained in separate dossiers.
Allergen segregation and staff protection
Storage, weighing, processing and cleaning of allergenic materials.
Controlled processing and protein recovery
Process development and control; no recipe, temperature or time is supplied as a validated setting.
Uniformity, redispersibility and dosing device
Demonstrating consistent concentration in the finished product and delivery device.
Microbiology, packaging and stability
Developing a justified use period for the exact allergenic matrix.
Allergen label and safe handover
Preventing allergen, concentration and dose mix-ups.
Incident, recall and reassessment
Reaction, suspected deviation or change involving an allergen batch.
Practical adoption sequence
- Assess laboratory risks and capabilities.
- Resolve source issues and approve the master record.
- Establish process, equipment and testing suitability.
- Train staff, use controlled batch records and document release.