FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Quality system / Master formulation and batch record · SOP-008

SOP-008 / 2.1

Master formulation and batch record

Converting a bibliographic monograph into a controlled local master record.

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

Download bilingual PDFJSON

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.

Additional detail

Master record F-002 holds approved instructions and limits. F-003 holds actual lots, weights, times, temperatures, losses and results for each batch. Assess base, container or concentration changes before reusing a previous BUD. A bibliographic monograph PDF is not a completed production record.

Record the date/time of the first compounding manipulation separately from completion/filling. BUD runs from initiation, not release or handover.

Stop criterion

Missing critical entries or untraceable batch: do not release.

Related forms

F-002, F-003

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. 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