ISPE Issues GAMP Electronic Data Archiving Guide
ISPE (Tampa, FL), a not-for-profit association of pharmaceutical manufacturing professionals, has just released its latest technical publication, "GAMP Good Practice Guide: Electronic Data Archiving."
ISPE (Tampa, FL), a not-for-profit association of pharmaceutical manufacturing professionals, has just released its latest technical publication, “GAMP Good Practice Guide: Electronic Data Archiving.” The guide seeks to provide a rational and scaleable approach to electronic data archiving through the development of an archiving strategy. The implementation of this strategy should help organizations achieve and maintain regulatory compliance, and effectively manage electronic records over the long term. This guide is intended as a supplement to the main good automated manufacturing practices (GAMP) guide.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
