EMA: New Q&A for Co-Processed Excipients
The EMA has published new Questions & Answers on co-processed excipients (CoPEs) used in solid oral dosage forms, introducing a harmonised, risk-based regulatory approach applicable to human and veterinary medicines.
What are co-processed excipients?
Co-processed excipients are combinations of two or more Ph. Eur. excipients
processed together using a physical process (e.g. spray-drying), without
formation of covalent bonds. They provide specific functionalities that cannot
be achieved by simple blending. CoPEs are not considered novel excipients nor
intermediates.
What are the risks?
Compared to single excipients, CoPEs may introduce additional risks, including:
- increased material variability
- impact on critical quality attributes (CQAs) such as dissolution, stability or bioavailability
- higher complexity in analytical control and manufacturing robustness
Risk categories and risk assessment
The EMA defines three risk categories:
- Category A – high risk
- Category B – medium risk
- Category C – low risk
Classification is based on a comprehensive risk assessment, considering:
- function of the CoPE in the finished product
- impact on CQAs and critical process parameters
- number of excipients in the CoPE
- proportion of the CoPE in the formulation
Risk assessment should follow ICH Q9 principles. For human medicines, alignment with the Formalised Risk Assessment (FRA) for ascertaining the appropriate good manufacturing practice for excipients is expected. The FRA does not need to be submitted in the dossier but should be available to inspectors during GMP inspections.
Source:
EMA: Questions and answers regarding co-processed excipients used in solid oral dosage forms
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