Checklist

Radiopharmaceutical Tech Transfer Checklist

A practical operational checklist for radiopharmaceutical technology transfer

Purist Inc.

Radiopharmaceutical
Tech Transfer Checklist

A manufacturing-focused operational checklist for radiopharmaceutical technology transfer, from facility assessment through process validation and commercial readiness.

Technology transfer in radiopharmaceutical manufacturing involves more than transferring a process from one site to another. Success depends on alignment across radiation infrastructure, regulatory approvals, quality systems, radionuclide supply, logistics, personnel qualification, and governance. Unlike conventional pharmaceutical manufacturing, radioactive decay, radionuclide licensing, and radiation safety requirements introduce additional operational constraints that can affect project timelines and readiness. This checklist is intended as a practical operational framework to support transfer planning, risk identification, and readiness assessments.

This checklist was developed based on publicly available regulatory guidance, industry practices, and observations from discussions across the radiopharmaceutical manufacturing, regulatory, quality, and supply chain ecosystem.

Important disclaimer. This checklist is provided for general informational purposes only and does not constitute legal, regulatory, medical, scientific, or professional advice. Applicable laws and regulations vary by jurisdiction and change over time, so consult qualified professionals before making compliance decisions. Purist Inc. and the author make no warranties as to the accuracy or completeness of this checklist and disclaim all liability for outcomes related to its use. Users are solely responsible for ensuring compliance with applicable laws and regulations in their jurisdiction.

Category key

Critical path
Must be completed before the transfer can advance to the next stage.

Regulatory
Requires interaction with or submission to a pharmaceutical or radiation regulatory authority.

Operations
Manufacturing, equipment, logistics, and personnel readiness items.

QC / Analytical
Method transfer, testing, validation, and quality system items.

Stage 01 Radiation Infrastructure and Facility Fit Assessment

	Hot cell shielding specifications reviewed against the emission type and activity levels of the specific radionuclide being transferred Shielding adequacy is product-specific. Confirm against this product's actual radiation characteristics, not the facility's general use case.	Critical path
	Hot cell and isolator qualification status confirmed (DQ / IQ / OQ / PQ) per applicable sterile manufacturing requirements (FDA 21 CFR Part 211, USP <797> / <825>, or EU GMP Annex 1, as applicable by jurisdiction) and the receiving site's Validation Master Plan	Critical path
	Radioactive material license at receiving site confirmed to cover the specific radionuclide, chemical form, and activity levels of the transfer product If coverage is absent or insufficient, initiate amendment or new application immediately. License timelines frequently determine overall project timelines.	Critical path
	Radiation Safety Officer (RSO) appointed, qualified, and formally recognized by the relevant radiation regulatory authority	Regulatory
	Personnel dosimetry program in place: dosimeters assigned, monitoring schedule established, dose records system operational	Regulatory
	HVAC and differential pressure configuration verified as appropriate for radionuclide containment and GMP air quality classification	Operations
	Radioactive waste storage, decay-in-storage procedures, and disposal routes confirmed as compliant with applicable radiation safety regulations	Operations
	Contamination monitoring equipment installed and calibrated; personnel trained on survey and decontamination protocols	Operations
	Radionuclide production or supply source confirmed and qualified for the receiving site	Critical path
	Commercial-scale throughput capability assessed separately from clinical-scale qualification: hot cell capacity, synthesis module count, and batch frequency confirmed sufficient for projected commercial demand A site qualified for clinical-scale production is not automatically equipped for commercial volumes. This should be assessed explicitly and separately.	Critical path
	Synthesis module type, configuration, and software version at receiving site documented and formally compared against the sending site specification	Operations

Stage 02 Decay-Aware Process Documentation and Knowledge Transfer

	Batch records include explicit time constraints relative to End of Bombardment (EOB) or End of Synthesis (EOS) for every critical process step Step timing must be documented as a process parameter, not a guideline. The decay clock governs every milestone.	Critical path
	Radiopharma-specific CPPs and CQAs documented: specific activity, radiolabeling yield, radiochemical purity, radionuclidic purity, and pH at time of release	Critical path
	Synthesis route parameters include target design specifications, bombardment conditions, and recovery chemistry where applicable	Operations
	Precursor and cold kit specifications, supplier qualifications, and approved vendor list transferred and reviewed at the receiving site	Operations
	Radionuclide specification formally transferred: acceptable radionuclidic impurity profile, activity concentration range, and qualified supplier documented Radionuclide source is a critical raw material. A process developed with one supplier source may behave differently when transferred to another. Supplier change controls must be defined.	Critical path
	Product shelf-life specification documented with decay-corrected activity limits at time of patient administration, not only at point of release	QC / Analytical
	Cleaning and decontamination procedures for synthesis module, hot cell, and ancillary equipment fully documented and transferred	Operations
	Environmental monitoring program adapted to the receiving site layout: sampling points, frequencies, and alert and action limits documented	Operations
	Manufacturing, QC, and batch record systems at the receiving site verified to support the transferred process	Operations
	All SOPs and batch record templates reviewed for completeness by both sending and receiving site quality teams before pilot phase commences	Critical path

Stage 03 Dual Regulatory Alignment

	Pharmaceutical regulatory filing requirements assessed: IND/CTA amendment, marketing authorization variation, or new submission, as applicable by jurisdiction	Regulatory
	Radiation regulatory requirements assessed: radioactive material license amendment, new license, or facility inspection, as applicable Initiate at Stage 1, not here. Radiation licensing timelines frequently exceed pharmaceutical filing timelines.	Critical path
	Regulatory lead designated with expertise in both pharmaceutical regulation and radiation regulatory compliance, or two leads with clearly defined interface responsibilities	Regulatory
	Regulatory timelines for pharmaceutical and radiation tracks mapped to the overall project plan with critical path dependencies identified	Regulatory
	CMC documentation updated to reflect receiving site: synthesis module, equipment, and process parameters, including radionuclidic data, dosimetry, and decay specifications in relevant CTD modules	Regulatory
	Pre-transfer regulatory communication prepared for pharmaceutical authority where process changes trigger reporting or prior-approval obligations	Regulatory
	Pharmaceutical and radiation inspection schedules coordinated; inspection readiness documentation prepared for both frameworks independently	Regulatory
	Authorized user (AU) and qualified person (QP) designations confirmed at receiving site per applicable jurisdictional requirements	Regulatory

Stage 04 Decay-Constrained Validation and Analytical Method Transfer

	Validation protocol designed for the decay-constrained environment: batch scheduling, decision windows, and acceptance criteria calibrated to the product's usable shelf life Conventional pharma validation timelines do not apply without explicit adaptation for radioactive decay constraints.	Critical path
	Engineering and non-GMP pilot batches planned to identify process differences between sites before GMP validation batches commence	Operations
	Equipment bridging studies defined where synthesis module type, configuration, or target design differs from the sending site. Equivalency must not be assumed.	Operations
	Full QC method transfer package completed: radiochemical purity (iTLC / HPLC), radionuclidic purity, specific activity, sterility, bacterial endotoxins, pH, and visual appearance	QC / Analytical
	Rapid release testing methods validated at the receiving site under the same time constraints as product shelf life. QC must execute within the release window, not be planned around it.	Critical path
	Reference standards for radiochemical and radionuclidic purity testing qualified at the receiving site	QC / Analytical
	Process performance qualification (PPQ) batches executed per validated protocol; all CQA acceptance criteria met across all required batches	Critical path
	Stability program initiated or bridged to existing data; real-time and accelerated stability samples placed at the receiving site under appropriate storage conditions	QC / Analytical
	Process validation report authored, reviewed, and approved by quality at both sending and receiving sites before commercial production begins	Critical path

Stage 05 Supply Chain and Logistics Integration

	Transport container validated for the specific radionuclide, activity levels, and expected transit duration Must comply with IATA Dangerous Goods Regulations (Class 7) and all applicable national transport regulations.	Critical path
	Shipping time studies conducted under realistic routing conditions; product confirmed to meet release specifications on arrival at the point of distribution	Operations
	Production schedule designed backward from required release and distribution timing, not forward from manufacturing convenience	Operations
	Backup logistics routing validated and documented; contingency procedures defined for flight delays, customs holds, or transport failures	Operations
	For theranostic programs: diagnostic and therapeutic supply processes validated and coordinated simultaneously. Both arms must be transfer-ready in parallel, not sequentially.	Critical path
	Import and export licenses and customs documentation assessed for each international distribution lane; pre-clearance arrangements established where possible	Regulatory

Stage 06 Personnel Qualification and Training

	All manufacturing personnel trained and qualified in both GMP requirements and radiation safety protocols specific to the product being transferred	Critical path
	Radiochemists and nuclear pharmacists at the receiving site hold appropriate professional qualifications and, where required, specific regulatory authorizations	Regulatory
	Aseptic technique qualification completed for all personnel in sterile preparation steps, including aseptic process simulation (media fill) within the shielded environment	Operations
	Training records satisfy both GMP documentation requirements and radiation safety authority requirements. These are separate obligations and separate documentation systems.	Regulatory
	Cross-functional transfer team formally constituted with defined owners across CMC, quality, radiation safety, regulatory affairs, manufacturing, and logistics	Operations

Stage 07 Commercial Release and Post-Transfer Monitoring

	Batch release procedure established: batch record review, QC results review, and qualified person or authorized release function formally designated at the receiving site	Critical path
	Continued process verification (CPV) program established: critical parameters trended across commercial batches, control charts maintained, review frequency defined	QC / Analytical
	Ongoing personnel radiation exposure monitoring reviewed against regulatory limits at defined intervals; escalation protocol in place for approaching or exceeding dose limits	Operations
	Post-transfer technical support period agreed with sending site: duration, scope, escalation contacts, and knowledge-sharing obligations formally documented	Operations
	Deviation, OOS, and CAPA procedures adapted for the radiopharma context: investigation timelines account for product decay; batch disposition decisions executable within the available window	QC / Analytical
	Annual product review (APR / PQR) process established at the receiving site for ongoing GMP compliance and continuous improvement	Operations
	Formal transfer acceptance criteria defined and documented: transfer is not considered complete until sign-off achieved at each governance gate, including validation acceptance and commercial readiness approval Transfer completion should be a documented decision, not an assumption. Governance gates should require explicit approval from quality, regulatory, and manufacturing leadership.	Critical path
	Technology transfer agreement and quality agreement executed between sending and receiving sites, defining roles, responsibilities, data ownership, and escalation pathways	Operations
	Change control procedure operational: post-transfer changes to synthesis module, precursor supplier, QC methods, or process parameters subject to formal impact assessment before implementation	Critical path

Leila Safavi Purist Inc.
Radiopharmaceutical Tech Transfer Checklist Version 1.0 puristinc.com

Radiopharma CMC Tech Transfer

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