FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
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SOP-013 / 2.1

Sampling, QC and release

In-process and finished-product checks before supply.

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

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Procedure

  1. Before the batch define critical attributes, method, samples, limits and responsibilities. Do not set retrospective limits to fit results.
  2. Design sampling representative of location, time and container. Maintain sample identity and transport conditions.
  3. Record actual results, units, instrument and raw data. An “OK” entry alone is inadequate for a quantitative test.
  4. Link external analysis to the exact batch and method. Assess laboratory and method suitability for the specific matrix.
  5. Investigate an out-of-specification result before repeating. Do not test repeatedly to select only a passing result.
  6. The authorised pharmacist reviews the record, deviations, label, QC and BUD together. Record release, quarantine or rejection with reasons.

Additional detail

Before analysis define method, sample, units and criteria from the applicable specific standard. Do not use a universal 90–110% or 95–105% range for all forms. Critical identity, strength, uniformity or microbiological failure precludes release. The reviewer examines raw data and deviations, not only a pass certificate.

The approved plan separates per-batch checks, initial method/process verification and periodic studies. A universal full analytical panel is not imposed on every preparation. For OOS retain original samples/data where possible; invalidation needs a specific documented cause, not merely a passing retest.

Stop criterion

Pending critical testing or unresolved OOS: quarantine, not provisional release.

Related forms

F-005, 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
  4. FDA — Investigating Out-of-Specification Test Results for Pharmaceutical ProductionGuidance for Industry, May 2022, Revision 1Sections III–V; chemistry-based tests, investigation, retesting, resampling and reportingIndustrial chemistry-test guidance; scientific investigation principles adapted to pharmacy QC. Not biological-assay validation or automatic Greek regulatory requirements.2026-10-14
  5. EMA/ICH — Q14 Analytical procedure developmentStep 5, effective 14 June 2024; 4 April 2025 error corrections; current EMA PDF checked 14 October 2026Sections 1.2, 2–3, 5–6; glossaryCommercial drug analytical development guideline, used as an explicitly scoped scientific method-design framework; does not impose a universal assay panel or pharmaceutical registration obligations on a pharmacy.2026-10-14