FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
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SOP-003 / 2.1

Training, hygiene and clothing

Staff, visitors and contractors entering the compounding area.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.1Record editorial review date: 2026-10-14

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Procedure

  1. Define permitted tasks for each role. Initial training covers SOPs, calculations, records, cleaning and incident response.
  2. Assess competency through observation and documented practice work. Reassess after significant changes or errors.
  3. Perform hand hygiene before entry, after contamination and when changing activities. Exclude food, drinks and personal items.
  4. Wear clean laboratory clothing and hair covering. Select gloves and eye/respiratory protection from SDS and task risk assessment.
  5. Change gloves and contaminated clothing between incompatible tasks. Gloves do not replace hand hygiene.
  6. Report health conditions or sensitisation affecting safe work confidentially to the designated responsible person. Assign suitable alternative tasks.

Additional detail

F-011 records task-specific training and observed competence: weighing, independent calculation, cleaning, deviation handling and safe PPE removal. Reading an SOP alone does not establish practical competence. Reassess the affected task after a significant change or observed error.

This template selects documented competency reassessment at least every 12 months, with earlier assessment after a critical change or error. This is an adoption policy to be checked against applicable local requirements.

Stop criterion

Untrained staff or unsuitable PPE: no unsupervised compounding.

Related forms

F-011, F-001

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 defaults2026-10-14
  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 revision2026-10-14
  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 certification2026-10-14
  4. Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic regulatory checklist, accessed 2026-09-12pp. 15–16; USP <795> sections 10.1–10.5Temperature conditions and requirements for supported extension; jurisdiction-specific guidance2026-10-14