SOP-011 · Powders and hard capsules
Non-sterile solid forms with controlled uniformity and exposure.
Template for local scientific review and approval. This is not an approved SOP of a specific laboratory.
SOP-011 · 1.0 · 10.09.2026
Scope
Non-sterile solid forms with controlled uniformity and exposure.
Roles and prerequisites
Responsible pharmacist: approves implementation and release. Trained operator: performs and records work. Reviewer: verifies critical items. Specialist clinician/analytical partner: as specified.
Before implementation complete local document IDs, named roles, suitable equipment, specific specifications and acceptance criteria. Check the applicable framework in your country.
Procedure
Verify active, diluent, shell and dosage-unit suitability. Check that dust can be handled safely.
Record particle-size and powder properties where they affect blending and segregation. Volumetric filling alone does not demonstrate content.
Independently verify calculations and any premix. Apply the documented dilution and blending sequence.
Check cleanliness, setup and capacity of filling equipment. Record losses, unit count and residues.
Perform mass checks and, where required, content-uniformity testing using suitable sampling. Equal mass does not imply equal active content.
Select moisture/light protection from evidence. Reconcile prepared, tested, rejected and supplied units.
Stop criterion
Inadequate uniformity or unreliable weighing/containment: stop.
Related records
Sources
- AEMPS PN/L/FF/001/00 — Cápsulas duras
- AEMPS PN/L/OF/001/00 — Pesada
- NAPRA — Guidance Document for Non-sterile Preparations
These sources inform the original editorial synthesis. Their publishers do not adopt or endorse this SOP.
Local approval
Local version: __________ Effective date: __________
Author: __________ Reviewer: __________ Pharmacist approval: __________
Signatures / dates: __________ Next review: __________