FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Quality system / Water quality, receipt and use · SOP-025

SOP-025 / 1.0

Water quality, receipt and use

Water as an ingredient in nonsterile preparations and cleaning water; does not validate a sterile-water system.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 1.0Record editorial review date: 2026-10-14

Download bilingual PDFJSON

Procedure

  1. The responsible pharmacist defines required water quality from the formula and use. Where purified water is specified, select corresponding compendial quality.
  2. Record supplier/system, lot, container, CoA or approved testing programme, dates and receipt conditions. Drinking bottled water is not automatically purified water.
  3. Review required chemical and microbiological evidence before acceptance. For an on-site system define outlets, sampling, maintenance and limits from the applicable specification.
  4. Define protected handling, in-use/hold time and storage from source evidence or a specific study. Do not invent a universal period for all waters.
  5. Link water used to every F-003. Distinguish final-rinse water from potable wash water and assess residue/microbial risk.
  6. Failure or unknown critical quality triggers water quarantine and review of all linked batches through F-007.
Stop criterion

Unknown identity/quality or unacceptable storage: do not use water as an ingredient.

Related forms

F-019, F-017, F-003, 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 defaults2026-10-14
  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