EMA Clarifies “Novel or Complex Manufacturing Process” Definition
In its Quality of Medicines Q&A – Part 1, the EMA has clarified how “novel or complex manufacturing processes” should be interpreted for variation categories Q.II.b.1 (new/replacement finished product manufacturing site) and Q.II.b.4 (change in batch size).
Such processes involve technologies that pose specific risks during site transfer or scale-up, potentially affecting product quality and thus requiring a Type II variation. Not all “non-standard processes” qualify as complex - aseptic processing, for example, is not considered complex for this classification, but as it is a non-standard manufacturing process, production scale process validation data is required.
Examples of complex processes include:
- ATMPs, liposomal and nanoparticulate preparations,
- Parenteral modified-release products,
- Metered-dose inhalers and DPI,
- Multilayer tablets.
Examples of novel processes include:
- Continuous manufacturing, decentralised manufacturing,
- Decentralised manufacturing
- Additive manufacturing,
- Use of process models,
- Personalised medicine production.
Applicants submitting a Type IB variation must justify why the process is not novel or complex. If the justification is rejected, authorities may request withdrawal and resubmission as Type II. Pre-submission consultation and the use of Post Approval Change Management Protocols (PACMPs) can help ensure correct categorisation.
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