FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
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SOP-001 / SOP v2.0

Document control and local adoption

Every SOP, monograph, master record and form used in the laboratory.

Download individual SOP · PDF

Procedure

  1. The responsible pharmacist assigns a document owner, author and independent reviewer. Downloading from this site is not local approval.
  2. Record the identifier, version, source, access date and applicable requirements. Check references, units and unresolved monograph issues.
  3. Complete F-001 with the local implementation: facility, equipment, responsibilities, tests and acceptance limits. Justify every departure from the template.
  4. Approve with signatures and an effective date before use. Train staff and document competency assessment.
  5. Provide one controlled active version at the workstation. Withdraw obsolete copies while retaining historical batch records.
  6. Set a review date and trigger an unscheduled review after source, material, equipment or incident changes. Assess affected batches.

Edition-specific detail

Each document carries a unique ID, revision, effective date, author, reviewer and approver. Activate a new version after withdrawing obsolete printed copies and training affected users. Annual system review is this template’s chosen local policy; a critical change or incident triggers earlier review.

Stop criterion

Without local approval, training or resolution of critical ambiguity: study use only.

Related forms

F-001, F-002

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 defaults2026-09-12
  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 revision2026-09-12
  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 certification2026-09-12