Updates on GMP inspections, regulatory guidelines and enforcement actions that matter to medicines manufacturers and regulators.
A quiet week for regulation, but not for public health: Nigeria’s confirmed imported Ebola case tests the operational readiness of every organisation running trials, laboratories or supply chains in West Africa.
Software linked to medicines, corporate network performance, safety-data lineage and post-market responsibilities are all moving further into the Quality leadership agenda.
Regulators are placing greater weight on the trustworthiness of evidence, lifecycle governance of AI and demonstrable Quality oversight, even as regulatory pathways become faster and more proportionate.
The MHRA has published its 2015 GMP inspection deficiency data, with quality system findings topping the list of critical and major deficiencies.
WHO has set up 160 disease detection sites in north-eastern Nigeria, where 3.7 million people urgently need health services.
WHO’s draft umbrella guideline on process validation runs to 21 pages and is expected to replace Annex 4 of WHO Technical Report Series No. 937.
The FDA warned Corden Pharma Latina over cracked, dirty floor tiles in the aseptic area and inadequate cleaning procedures.
A data integrity warning letter explicitly asks for a CAPA plan, an investigation and a risk assessment, which may signal a trend.
