In its biosimilars advice document, the EMA answers 43 questions about the process for approving biosimilars. Part of this process includes biosimilar GMPs (good manufacturing practice) as well as inspection requirements in Europe. For facilities located outside of the European Economic Area (EEA), the EMA typically does GMP compliance inspections if more than three years have passed since their last regulatory visit. For these situations, the EMA wants these facilities to send an early warning inspection request to avoid delays. Also, the EMA has created a fast-tracks process which means that the inspection will take place within three months of receiving the early warning inspection request. To read more click here. To view the biosimilars advice document, click here. For help with your GMP quality system or auditing services, contact Pearl at contact@pearlpathways.com.
