EMA: Updated Q&A on GMP/GDP Topics

The European Medicines Agency (EMA) answers frequently asked GMP/GDP questions discussed in the GMP/GDP Inspectors Working Group in its Guidance on good manufacturing practice and good distribution practice: Questions and answers. The document is continuously revised, as last in October 2022. The answers are intended to provide additional clarification to the current EU GMP and GDP regulation.

This new question regarding the nature of check at the reception of veterinary medicinal products as layed down in Art. 23 (3) of regulation 2021/1248 requirement relating the nature of check at the reception of veterinary medicinal products before being transferred to saleable stock was incorporated in October:

• What kind of proof of release to the market could be requested and controlled by the staff of WDA holder for ensuring that recived veterinary medicinal products coming from another Member State be transferred to saleable stock?

In February this year, these seven questions regarding the requirements for active substances used as starting materials in veterinary medicinal products were added:

• Do active substances used as starting materials in veterinary medicinal products have to comply with Good Manufacturing Practice ("GMP") for active substances?
• Are there any new obligations for active substances used as starting materials in veterinary medicinal products under the Veterinary Medicines Regulation?
• How is a GMP certificate issued?
• Is a GMP certificate mandatory for manufacturing sites?
• Can manufacturers of active ingredients used as starting materials for veterinary medicinal products apply for a GMP inspection on a voluntary basis?
• Can manufacturers of active substances used as starting materials for veterinary medicinal products imported or manufactured in the Union be inspected by an EU authority?
• Can inspections conducted by the competent authorities of a third country competent authorities be considered whern  deciding whether a Union inspection should be triggeret?

Source:

EMA: Guidance on GMP and GDP: Q&A