Markus Junior Maring, product manager, Filtration Consumables, and Marine Cannuel, manager of validation services, examine how specialised validation services can help manufacturers strengthen Annex 1 compliance.
FUJIFILM Biotechnologies held a ribbon‑cutting ceremony to mark the opening of its new, 2,000‑square‑meter (m2) quality control (QC) laboratory at its Hillerød, Denmark, commercial‑scale manufacturing site.
Megha Sinha, founder and CEO of Kamet Consulting Group explains why the systems most manufacturers use to manage post-approval changes are no longer fit for purpose, and what a viable alternative looks like in the AI age.
Since the introduction of formal GMP regulations in the 60's and 70's, the batch record has been a cornerstone of how pharmaceutical manufacturing operates. David Margetts, group executive director of Factorytalk and BatchLine discusses.
Ampacet, a specialist in masterbatch solutions, has announced the achievement of ISO 13485 certification, a benchmark for quality management systems in the medical device sector.
Martin Kühn, managing director, and David Kötterheinrich, head of marketing at ERWEKA shares how pharmaceutical quality control and research laboratories, dissolution testing remains one of the most critical, and regulated, analytical processes.
John Donahue, vice president of sales, Scientific Safety Alliance discusses how a single contaminated batch triggers a chain of events that manufacturing teams may spend weeks, sometimes months, unraveling.
Contract research organisation Broughton has achieved Good Manufacturing Practice (GMP) accreditation at its Oak Tree House facility in Lancashire, following an inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA).
