Product realisation

Quality from programme to supply.

A viable medicine needs a product route that can deliver consistent quality and dependable supply. Manufacturing requirements are considered early, with responsibilities defined clearly when specialist partners are involved.

Early feasibility

Feasibility starts with the product.

The dosage form, process, controls and supply route must work together before a programme can move forward.

Product requirements

Define the ingredient, strength, dosage form, presentation and critical quality attributes.

Technical route

Test formulation, process complexity, analytical needs, material availability and the evidence required to control the product.

Practical scale

Consider capacity, packaging, storage and distribution so the proposed route is workable beyond development batches.

Quality responsibilities

Quality runs through the lifecycle.

Responsibilities need to remain visible from development and transfer through routine manufacture and continuing supply.

Define

Set suitable specifications, methods, controls and acceptance criteria for the product and its stage.

Qualify

Assess whether proposed organisations, sites, suppliers, materials and services fit the product and intended markets.

Control

Plan validation, release, deviation handling and change control with clear responsibilities and escalation routes.

Review

Use product, process, stability, supplier and supply information to identify issues and guide appropriate action.

Partnered manufacture

Partnerships need clear ownership.

When external manufacturing expertise is involved, capability, responsibilities and decision rights should be matched to the product and stage.

01
Assess fit
Review technical capability, quality history, capacity, materials and the requirements of the intended markets.
02
Assign responsibility
Define oversight, information access, decisions, escalation and each organisation's obligations in clear agreements.
03
Transfer knowledge
Share the process, methods, materials and development learning through a controlled plan with agreed acceptance criteria.
04
Verify and maintain
Evaluate transfer results, resolve differences and carry the knowledge into validation, routine manufacture and later changes.

Continuity of supply

Supply resilience is product-specific.

A dependable route accounts for the whole supply chain, not only the manufacturing batch.

Planning should consider lead times for active ingredients, excipients, components and packaging, alongside capacity, testing, release, storage and distribution. Single sources and long replacement timelines need particular attention.

The right safeguards depend on volume, shelf life, technical transferability and available alternatives. They may include suitable inventory, additional qualification, contractual commitments, alternate routes or a defined response plan.

Manufacturing partnerships

Have a development, manufacturing or packaging capability that fits a defined product need?

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