Technology transfer for pharma and biotech: analytical methods and manufacturing processes moved between sites with the charter, RACI chart, project plan and Process FMEA on one record

The QLogix Tech transfer module moves a product's analytical methods or manufacturing process from a sending team or site to a receiving one, within a company or between companies, on audited, signed records. A transfer starts with its project charter, its team and RACI chart in Operational excellence and its project plan in Project management, then holds the bill of materials with the equivalence of every material, the methods with their transfer approach, acceptance criteria and measurement system analysis, or the unit operations with the critical quality attributes and the critical process parameters tied to them under the Process FMEA, the transfer package, the risk register, the readiness actions and the runs from the engineering batch to the PPQ batches. The AI drafts the registers from the description, the documents and the linked records; the team settles them, approves the plan with signatures, executes, and closes the transfer with its outcome and lessons learned.

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What the module does

  • Two transfer types. An analytical method transfer lists every procedure with its transfer approach (comparative testing, co-validation, revalidation or a justified waiver), its acceptance criteria and the measurement system analysis the receiving laboratory must demonstrate: repeatability, reproducibility between analysts, instruments, days and laboratories, and accuracy against the sending laboratory's results. A manufacturing process transfer names its platform and lists every unit operation with the sending and receiving equipment and scale.
  • Two platforms for a process transfer. A small molecule process runs from API compounding through fill and finish or lyophilization to packaging and labeling; a biopharmaceutical process from the drug substance unit operations (upstream and downstream) through drug product formulation, filling and final packaging and labeling.
  • The starting points of a transfer, before anything else is approved: a project charter (purpose, objectives, success criteria, deliverables, assumptions, constraints, sponsor, dates), the transfer team by role on both sides, the RACI chart started in Operational excellence from that team and the activities of the transfer, the project started in Project management from a built-in template seeded with the charter, and a risk register scored for probability and impact with a mitigation and an owner for every High risk.
  • The bill of materials: every input material at the sending site and its equivalent at the receiving site, rated identical, equivalent with its evidence, to qualify or a gap, each gap carried by a readiness action.
  • The critical quality attributes with their acceptance criteria and the critical and key process parameters of every unit operation, each tied to the CQAs it affects, with the Process FMEA in Risk assessment as the reference: the FMEA's failure modes are pulled in as parameters, and each parameter names the failure modes that carry its effect.
  • The transfer package: the documents the sending site hands over and the receiving site adopts, from the transfer protocol to the master batch records, methods, specifications, validation and development reports, with the receiving site's own document reference recorded on adoption.
  • Readiness actions with owners and due dates: supplier qualification, equipment changes and qualification, scale-down studies, documents written for the receiving site, training assigned from the action in the Training module, the regulatory variation and supply, each done with its evidence.
  • Runs tied to their records: an engineering, demonstration or PPQ batch to its executed batch record in the MES, comparative testing to its LIMS samples, with the record's disposition, deviations and OOS results read on the transfer and the outcome they suggest.
  • AI drafting of every register from the scope and intent, the description, the attached documents, the linked records and the guidance (ICH Q2(R2), Q14, Q8 to Q11, EU GMP Annex 15, the FDA process validation guidance, USP <1224>); rows the team settled survive a redraft.
  • Transfer plan approval as a signed milestone, execution, then a signed closure with the outcome, the closure summary and the lessons learned, and the whole dossier exported as a locked PDF.

How it fits the platform

A tech transfer runs on the modules around it. Project management holds the transfer project with its phases, tasks, milestones, resources, baseline and forecast, and the project's health is read on the transfer. Operational excellence holds the RACI chart and the improvement records the transfer starts: an action plan for the readiness actions, an A3 for a gap or a failed run, change management for the receiving site's organization, a kaizen event. Risk assessment holds the Process FMEA that references the CPPs and CQAs. The MES and the LIMS carry the batches and the samples the runs are tied to. The Training module carries the assignments started from the readiness actions. Document management indexes every transfer, reads the controlled documents at their effective version and offers to start a transfer.

Q Intelligence lists and reads tech transfers, with their type, platform, parties, connected records, materials and operations open, methods passed and failed, CPPs, package, actions open and overdue and runs, and can open one from a conversation with the form prefilled for a person to review and create. Q Agent proposes opening or drafting a transfer as an action that waits for approval. Alert rules tell the right people when a readiness action is overdue or a method transfer failed, and the lessons learned of a closed transfer join the Operational excellence lessons page.

Where people decide

The AI reads and drafts: the team, the risks, the materials and their equivalence, the methods and their criteria, the unit operations, CQAs and parameters, the package and the readiness actions. The team settles every row with a reason where the rules ask for one, names the people, agrees the RACI chart, assesses each material and operation on evidence, classes each parameter and ties it to its CQAs, passes each method on its measurement system analysis, records each run's outcome and decides the closure. The approvers sign the plan and the closure.

Questions about Tech transfer

What is a technology transfer in pharma?

A technology transfer moves a product's manufacturing process or its analytical procedures from the team or site that developed or ran them to the one that will run them from now on: from development to commercial manufacturing, from one site to another, or to a contract manufacturer or laboratory. ICH Q10 describes it as the transfer of product and process knowledge; EU GMP Annex 15 and the FDA process validation guidance set what the receiving site must demonstrate. In QLogix the transfer is one record that holds the knowledge, the plan and the evidence.

Why do the RACI chart, the charter and the project plan come first?

Because most transfers fail on responsibilities and planning before they fail on science. QLogix starts the RACI chart in Operational excellence from the transfer team and the activities of a transfer of that type, starts the project in Project management from a built-in template seeded with the charter, and does not route the plan for approval until both exist and the charter states the objectives, the success criteria, the deliverables, the sponsor and the finish.

How does the module handle the CPPs and CQAs of a process transfer?

The critical quality attributes are listed with their acceptance criteria, and every process parameter of every unit operation is classed critical, key or non-critical and tied to the CQAs it affects. The Process FMEA in Risk assessment is the reference: its failure modes can be pulled in as parameters, each parameter names the failure modes that carry its effect, and the plan is not approved while a CPP has no CQA or no range.

What is the measurement system analysis of an analytical method transfer?

The demonstration that the receiving laboratory measures as the sending one does: repeatability under the same conditions, reproducibility between analysts, instruments, days and laboratories, and accuracy against the sending laboratory's results on the same lots or against a reference. Each method carries a criterion, a result and an outcome for the three characteristics, and is passed only when every one meets its criterion or is justified as not required.

Can the AI draft the transfer?

Yes. From the scope and intent, the description of the process or the methods, the attached documents (master batch records, methods, validation and development reports, specifications) and the linked records, including the Process FMEA, the AI drafts the team, the risk register, the bill of materials, the methods or the unit operations, CQAs and parameters, the transfer package and the readiness actions, and searches the guidance where a judgment rests on it. The team settles every row; rows it settled survive a redraft.

How are the runs recorded?

Each feasibility run, comparative testing study, engineering, demonstration or PPQ batch is a run with its reference and date, tied to the executed batch record in the MES or the LIMS samples that carry it. The transfer reads the record's disposition, deviations and OOS results and the outcome they suggest; the team records the outcome, with a reason where the rules ask for one. Closure needs at least one conforming run.

How is it licensed?

Per user per month, on its own or with other modules, ordered by purchase order from the client portal. AI use is included in the licence. There is no card payment or self-serve plan.

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