PUB-005 / v2.0
Ingredient and finished-preparation compatibility
The finished matrix is the object of assessment. Suitable individual materials or commercial products do not alone establish suitability of their combination.
Exact formulation and controlled process
A formulation’s identity includes active chemical form, concentration, excipients, water, preservatives and starting products. Changing a salt, base or tablet type is not merely a naming change. The process specifies addition order, mixing, thermal stages and final volume or mass. The laboratory establishes that its equipment can achieve those conditions.
Compatibility of the final matrix
Mechanical mixing does not establish solubility, uniformity or chemical compatibility. Assess pH, crystallisation tendency, emulsion structure and preservative partitioning. A concentration stated for the original base may change after dilution. The two starting products’ expiry dates do not establish the mixture’s lifetime.
Tests that answer the question
Appearance identifies some failures but does not establish strength, absence of degradants or microbiological suitability. Select method and criterion for the actual dosage form and use. A suspension needs redispersibility and device-delivered-dose assessment; at low strength, uniform mass does not imply uniform API. A critical specification failure requires quarantine and investigation.
Dating with explicit conditions
BUD follows evidence for the actual formula or an applicable default after checking its conditions. A default duration is not a stability experiment. Temperature, container, microbiological condition and component expiries constrain the decision. Numerical rules appear in SOP-014 and PUB-013; record batch rationale in F-006.
Sources and references
- 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
- 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
- USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12