Martine Powell

Expert GMP Inspector

Contamination Control Reminder: Managing Bacillus Risks in Aseptic Processing

Posted by: , and , Posted on: - Categories: Good manufacturing practice

The MHRA’s inspectorate and the Defective Medicines Report Centre (DMRC) are actively liaising with NHS and Specialist Pharmacy Services (SPS), following an increase in reports of Bacillus contamination in aseptic facilities. While no firm link has been identified between these …

Decentralised Manufacturing: emerging considerations

Posted by: , and , Posted on: - Categories: Clinical Trials, Decentralised Manufacturing, Good manufacturing practice, Innovation, Med Regulations, Point of Care

Decentralised Manufacturing (DM) is the overarching term used in the UK to cover the two elements of the new manufacturing and supply framework: point of care (POC) and modular manufacturing (MM). A cross-agency team of Quality and Clinical Trial assessors, …