Annex 1 of the European Union GMP document provides specific guidance on the production of sterile medicinal products, covering various aspects such as facilities, equipment, validation, environmental monitoring, and personnel. Its aim is to establish a harmonized approach to ensure the highest quality standards throughout the manufacturing process.
Definition of Day zero or consideration of Day Zero in cases where the Company uses third party call center to perform intake of complaints from the open channel for a toll free number, fax, Web email
Webinar - Complaint Handling - Best Practices Some regulatory inspectors interpret response as an action finding and not a simple acknowledgement of receipt. Are we seeing a trend in one direction?
Webinar - FDA Off-Label Promotion Guidelines