FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
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SOP-005 / SOP v2.0

Facility, cleaning and line clearance

Non-sterile compounding area and shared equipment.

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Procedure

  1. Define receiving, quarantine, clean-material, compounding and finished-product zones. Arrange workflow to limit mix-ups and cross-contamination.
  2. Before each job remove materials, labels and documents from the previous batch. Record line-clearance verification.
  3. Use an approved cleaning procedure for each surface and residue. Define agent, concentration, contact time and rinsing from suitability evidence.
  4. Record scheduled and exceptional cleaning, operator, materials and outcome checks. Disinfection does not replace removal of chemical residues.
  5. For potent substances or allergens use specific residue controls and demonstrated cleaning suitability. Visual cleanliness is insufficient.
  6. Monitor temperature, humidity or other conditions where product quality depends on them. Record excursions and risk-appropriate waste management.

Edition-specific detail

Line clearance covers residual materials, previous labels/documents, clean equipment and the correct next formula. Record cleaner, concentration, contact time and final rinse. Visual cleanliness does not establish absence of potent drug or allergen; use SOP-022/F-015 when quantitative assessment is required.

Stop criterion

Residue, unknown previous material or undocumented cleaning: do not use the workstation.

Related forms

F-004, F-007

Sources and references

  1. NAPRA — Model Standards for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 4–9Risk, personnel, facilities and QA; its historical BUD table is not used for current USP defaults2026-09-12
  2. 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
  3. PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12