Covid-19 pandemic has led to different restrictions that may also have an impact on some on-site Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) inspections.
The Q&A recently issued by the European Commission, EMA and the European medicines regulatory network has articulated appropriate measures to address such restrictions and minimize risks of shortages while ensuring that the high standards of quality, safety and efficacy of medicines made available to patients in the EU are maintained.
The measures put in place in order to guarantee the continuous respect of GMP and GDP requirements are the extension of the validity until the end of 2021 for:
- GMP certificates and authorizations to the manufacture and importation of medicinal products (using different approaches for sites located in the EEA and outside the EEA)
- GDP certificates and authorizations to wholesalers and distributors
Some adaptations (always in respect of the GMP requirements) have been introduced also to the role of the Qualified Person (QP), such as:
- remote batch certification
- remote audits of the active substance manufacturer
- remote batch release of investigational medicinal products imported from third countries.
Regulatory Pharma Net team is available to fully support companies for any query.