Questions and answers regarding co-processed excipients used in solid oral dosage forms

This Q&A applies to human and veterinary medicines.

The document outlines the quality requirements for co-processed excipients (CoPE) used in solid oral dosage forms in both human and veterinary medicinal products. The use of CoPEs in pharmaceutical formulations is considered to have a higher degree of risk than using individual excipients due to several factors: for example complexity of composition, quality control, formulation development and stability issues. The Q&A aims to harmonise and quality clarify dossier requirements for CoPEs using a risk-based approach. It defines three risk categories for the CoPE and the risk factors the MAH/applicant should consider to identify the adequate risk category, and the related quality dossier requirements, which need to be provided by the MAH/applicants as part of new MAA or variations. 

Keywords: co-processed excipients, dossier requirements, risk categories

Documents

Questions and answers regarding co-processed excipients used in solid oral dosage forms (H & V)

Draft: consultation closedConsultation dates: 11/09/2024 to 31/12/2024Reference Number: EMA/CHMP/CVMP/QWP/422493/2024Summary:

This Q&A outlines the quality requirements for co-processed excipients (CoPE) used in solid oral dosage forms in both human and veterinary medicinal products. The use of CoPEs in pharmaceutical formulations is considered to have a higher degree of risk than using individual excipients due to several factors: for example complexity of composition, quality control, formulation development and stability issues. The Q&A aims to harmonise and quality clarify dossier requirements for CoPEs using a risk-based approach. It defines three risk categories for the CoPE and the risk factors the MAH/applicant should consider to identify the adequate risk category, and the related quality dossier requirements, which need to be provided by the MAH/applicants as part of new MAA or variations. 

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