FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
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SOP-016 / 2.1

External testing, data and change control

Analytical partners, digital records and quality-system changes.

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

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Procedure

  1. Agree in writing with the external laboratory on matrix, analyte, range, method, criteria, turnaround and deviation reporting.
  2. Check technical competence and, where relevant, accreditation scope. A general certificate does not establish suitability for every test.
  3. Maintain sample identity, conditions and receipt records. Link reports to the batch, method and raw data where needed.
  4. Restrict records by role. Keep change history, secure backups and restoration checks; do not upload patient details to the public website.
  5. Before material, method, source or equipment changes assess effects on strength, stability, exposure and previous batches. Define required comparisons.
  6. Approve changes only after testing, document updates and training. Monitor initial batches after implementation.

Additional detail

The external-laboratory agreement defines matrix, analyte, concentration range, method validation/verification, critical LOQ, sample transport and raw data. Assess the relevant accredited scope, not merely a general certificate. Document source-edition or base-manufacturer changes in F-013/F-016 before release.

State which attribute a method measures and which it does not cover. Laboratory/matrix verification of an established compendial or published method differs from developing and fully validating a new method. ICH Q14 is used here as a scientific framework, not a claim of industrial regulatory compliance.

Stop criterion

Untraceable data or uncontrolled critical change: do not use for release.

Related forms

F-005, F-007, F-013, F-016

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. EMA/ICH — Q14 Analytical procedure developmentStep 5, effective 14 June 2024; 4 April 2025 error corrections; current EMA PDF checked 14 October 2026Sections 1.2, 2–3, 5–6; glossaryCommercial drug analytical development guideline, used as an explicitly scoped scientific method-design framework; does not impose a universal assay panel or pharmaceutical registration obligations on a pharmacy.2026-10-14