FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Learning / Analytical testing and actual delivered dose · PUB-017

PUB-017 / 1.0

Analytical testing and actual delivered dose

No single test answers every quality question. The strategy selects which attribute needs evidence, by which method and at which stage.

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

Download bilingual PDFJSON

Mass, assay and dose

Equal capsule mass does not establish equal active content. A pooled-sample average does not establish unit uniformity. For a suspension, mean vessel assay does not establish the quantity delivered through a syringe after standing. Sampling must answer the specific question.

Method suitability

Define analyte, matrix, required range, units and acceptable uncertainty. Use suitable extraction/recovery and interference assessment. ICH Q14 principles inform measurement design here within their stated original industrial scope; they do not impose identical testing on all dosage forms.

Stability versus strength

Strength at one time point does not establish retention to BUD. An extension study needs a suitable stability-indicating method and additional physical/microbiological evidence. Low aw does not certify absence of degradants or dose uniformity.

Frequency and limits

F-005 specifies per-batch tests versus process verification, periodic checks or development studies. Limits follow the applicable standard/monograph and risk rationale. Do not apply a universal 90–110% range or omit a critical test because an instrument is unavailable locally.

Failure and documented investigation

For OOS retain data and samples where feasible, assess documented analytical causes and investigate process/other batches. Retesting or resampling needs justification. A new passing value does not automatically erase the original result. FDA principles are adapted as a scientific framework, not asserted as Greek regulatory requirements.

Sources and references

  1. 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
  2. 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
  3. 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
  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. USP — General Chapter <795> FAQsUpdated 1 November 2023; retrieved 14 October 2026Questions 52–66, especially 52, 54–56, 58–59, 61–64Publisher interpretation: optional formula-specific aw testing, initiation-date BUD, stock-component exceptions, exact-formula stability studies and antimicrobial-effectiveness testing. Not Greek law.2026-10-14