SOP-008 · Master formulation and batch record

SOP-008 · 1.0 · 10.09.2026

Scope

Converting a bibliographic monograph into a controlled local master record.

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

1. Select the exact monograph and edition. Review formula, dependencies, unresolved issues and source status before adoption.

2. In the master record define materials, specifications, batch size, equipment, stages, critical parameters and checks.

3. Justify packaging, label, storage conditions and BUD. Link each numerical limit to a specific source or local study.

4. Issue a blank batch record with a unique number linked to the active master version. Do not reuse a completed previous batch record as a new one.

5. Record actions and measurements when performed. Correct while preserving the original entry, reason, date and signature; never reconstruct invented data.

6. The reviewer reconciles materials, labels, yield, QC and deviations before signing release. Archive with access and retention defined by local requirements.

Stop criterion

Related records

• F-002 · Master formulation record
• F-003 · Blank batch record

Sources

• NAPRA — Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018; clarification 2022)
• AEMPS PN/L/PG/001/00 — Elaboración de procedimientos

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: __________