Resource library

Radiopharmaceutical Resources

Radiopharmaceutical resources for production windows, material lots, available and pending QC results, accountable review and software evaluation.

Guides: 3 guides
Glossary: 3 glossary entries
Checklist: 9 buyer questions

PET Manufacturing Reference

This US PET-drug regulation is not a universal rule for radiopharmacy, research or other markets. Your regulatory team determines applicability.

GuideRadiopharmaceutical Manufacturing Readiness — runs and dispatchDistinguish released stock, finite production and QC calendars, review capacity and actual shipment handover.Read the guide
Guide21 CFR 212 PET Drug cGMP ReadinessFollow material controls, master and batch records, laboratory evidence, human release decisions and recipient follow-up.Open
Glossary21 CFR Part 212 — definitions and release provisionsSeparate material release, final-release procedures, sterility follow-up and malfunction-based conditional final release.Open
GuideRadiopharmaceutical Release Before All Tests FinishAssemble batch and QC evidence, distinguish available, pending and failed results, and record the authorised decision, distribution and follow-up.Open
GlossaryDecay Correction — Reference-Time ActivityTranslate a known activity to another reference time, with uncertainty and model limits kept explicit.Open
GlossaryParametric Release — EU Terminal-Sterilisation ComparisonAn EU GMP concept for terminally sterilised products, shown for contrast; it is not a US PET release authorisation.Open
Reference21 CFR Part 212 — current PET drug CGMP regulationOfficial eCFR text covering PET-drug production, laboratory controls and release provisions.Read the reference

Software Pages

Compare the production workflow and laboratory information with your own site requirements.

Evaluate the software

Work through these questions with your production and quality teams, then use them to plan an evaluation with your own records.

Product, Site and Market ScopeAre we evaluating PET manufacture, radiopharmacy preparation or research, and which product and market rules has our regulatory team identified?

Precursor and Consumable IdentityCan we follow the actual precursor, cassette and vial lots, certificates and material-use decisions for one run?

Run and dispatch windowsHow will our planning team distinguish a planned dispatch window from actual preparation, sampling, review and handover times?

Approved Preparation InstructionsCan we identify the instruction revision used and reconstruct who performed and confirmed each preparation step?

Available versus pending QCWhich system owns samples and results, and how will outstanding tests remain visibly separate from entered and reviewed results?

Accountable Review AuthorityWho is authorised to decide for this product, which evidence must they review, and how will the decision and unresolved conditions be recorded?

Follow-up after dispatchWhere applicable under our approved procedure, who tracks later results, escalates a failure and records the customer notification and investigation?

Equipment and System ReadinessWhat calibration, maintenance, training, configuration and intended-use testing must our team verify before using the workflow?

Dispatch Handover and TraceabilityCan we connect the actual dispatched product and handover record back to the run and its material lots without implying a transport qualification service?

The existing operations guide remains email-gated. Discuss its product and market scope with your quality team; printing is available in the reader. Open the existing guide offer.

Explore the workflow

The illustrated five-step workflow follows material receipt, planning to a dispatch window, hot-cell preparation, available and pending QC results, and accountable review and dispatch.

Explore the radiopharmaceuticals workflow