SOP-001
Document control and local adoption
Every SOP, monograph, master record and form used in the laboratory.
Read and PDF →QUALITY / EVIDENCE
Laboratory quality system
36 bilingual documents in this edition.
SOP-002
Request and risk assessment
Before accepting a new preparation or material change. This does not validate sterile compounding.
Read and PDF →SOP-003
Training, hygiene and clothing
Staff, visitors and contractors entering the compounding area.
Read and PDF →SOP-004
Suppliers, receipt and raw materials
Active substances, excipients, commercial products and packaging materials.
Read and PDF →SOP-005
Facility, cleaning and line clearance
Non-sterile compounding area and shared equipment.
Read and PDF →SOP-006
Equipment, calibration and maintenance
Balances, thermometers, pH meters, mixers and volumetric equipment.
Read and PDF →SOP-007
Calculations and weighing
Batch calculations, units, potency corrections and weighing records.
Read and PDF →SOP-008
Master formulation and batch record
Converting a bibliographic monograph into a controlled local master record.
Read and PDF →SOP-009
Oral solutions, syrups and suspensions
Non-sterile oral liquids under a specifically approved master record.
Read and PDF →SOP-010
Semisolids, emulsions and gels
Non-sterile cutaneous forms; other routes require separate suitability assessment.
Read and PDF →SOP-011
Powders and hard capsules
Non-sterile solid forms with controlled uniformity and exposure.
Read and PDF →SOP-012
Packaging, labelling and handover
Every finished preparation and its safe-use instructions.
Read and PDF →SOP-013
Sampling, QC and release
In-process and finished-product checks before supply.
Read and PDF →SOP-014
Stability and BUD justification
Assigning a use period for the exact formula, packaging and conditions.
Read and PDF →SOP-015
Deviations, CAPA, complaints and recall
Errors, near misses and problems identified after supply.
Read and PDF →SOP-016
External testing, data and change control
Analytical partners, digital records and quality-system changes.
Read and PDF →SOP-017
Water activity measurement
Selecting water-activity evidence and, when needed, measuring the exact nonsterile matrix.
Read and PDF →SOP-018
Hazardous materials and volatile solvents
Operations creating exposure, dust, droplets or flammable vapours.
Read and PDF →SOP-019
Microbiological quality and preservative effectiveness
Nonsterile forms and preservation studies in the exact final matrix.
Read and PDF →SOP-020
Stability-study applicability and BUD extension
Acceptance of published or commissioned studies for an exact monograph.
Read and PDF →SOP-021
Storage and transport temperature
Maintaining the conditions supporting the BUD.
Read and PDF →SOP-022
Cleaning verification for actives and allergens
Shared equipment and surfaces at risk of residue carryover.
Read and PDF →SOP-023
Clinical excipient and dose review
Assessing order suitability for the actual patient.
Read and PDF →SOP-024
Sources versions and scientific publication
Updating compounding.gr and the controlled collection.
Read and PDF →OIT-001
Allergist interface and order verification
Laboratory support for individual allergen preparations. This is neither a treatment protocol nor manufacturing authorisation.
Read and PDF →OIT-002
Allergen identity and protein basis
Distinct food-allergen raw materials in separate dossiers: pistachio, peanut, cashew and, where a specific project is approved, milk/egg proteins.
Read and PDF →OIT-003
Allergen segregation and staff protection
Storage, weighing, processing and cleaning of allergenic materials.
Read and PDF →OIT-004
Controlled processing and protein recovery
Process development and control; no recipe, temperature or time is supplied as a validated setting.
Read and PDF →OIT-005
Uniformity, redispersibility and dosing device
Demonstrating consistent concentration in the finished product and delivery device.
Read and PDF →OIT-006
Microbiology, packaging and stability
Developing a justified use period for the exact allergenic matrix.
Read and PDF →OIT-007
Allergen label and safe handover
Preventing allergen, concentration and dose mix-ups.
Read and PDF →OIT-008
Incident, recall and reassessment
Reaction, suspected deviation or change involving an allergen batch.
Read and PDF →SOP-025
Water quality, receipt and use
Water as an ingredient in nonsterile preparations and cleaning water; does not validate a sterile-water system.
Read and PDF →SOP-026
Self-audit and quality-system review
Nonsterile laboratory system: documents, personnel, premises, equipment, materials, compounding, QC and handover.
Read and PDF →SOP-027
Suitability for an enteral feeding tube
Pharmaceutical assessment of the actual order/form before tube administration; does not set a therapeutic dose.
Read and PDF →SOP-036
Water activity, stability evidence and BUD assignment policy
Local policy and proposed laboratory design for local adoption. No tests have been performed in this project.
Read and PDF →