Guide
Your manufacturing is changing site, scale or supplier: how does the marketing authorization stay valid?
When a process moves to another site or to a larger scale, transfer, supplier qualification, validation, variation and batch release depend on each other. This page shows the stages in their order and links each one to the expert page with the details.
Typical triggers
- A product moves to another manufacturing site, within the company or to a contract manufacturer.
- A process goes from pilot scale into commercial production.
- A critical supplier drops out or gets a second, qualified source alongside it.
Last updated: October 19, 2026
The path in 5 stages
Stage 1
Plan and manage the transfer
At the end stands the transfer plan with milestones and a defined variation route, derived from the gap analysis between the sending and the receiving site. The approval path starts in parallel with the technical transfer, not behind it.
Stage 2
Qualify the supplier or CDMO
The new supplier or contract manufacturer is part of your quality system after a risk-based initial assessment, quality agreement and audit, and is monitored on an ongoing basis. Where needed, a second source is qualified.
Stage 3
Validate process and systems
Equipment and process are qualified and validated at the new location, documented in the validation report and followed up through continued process verification. If GMP-relevant IT systems change along with it, they are validated, scaled to the risk class.
Stage 4
File the change with the authority
The change is classified and filed; the classification decides when you may implement it. Because the authority has a review time, the filing is prepared in parallel with transfer and validation. In the US, supplements under 21 CFR 314.70 apply, for biologics under 21 CFR 601.12.
Stage 5
Release the batches
At the new site, a Qualified Person certifies the batches. If there is no QP on site yet, or the QP is not yet familiar with the product, an external QP bridges the gap; notification to the authority and onboarding should be in place before the first certification.
How we work with you
How we work with you in the stages is set by the format: Strategy, Hybrid or Operational Consulting.
Frequently asked questions
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