Artificial Intelligence writers and chatbots have seen huge success following a boom started by ChatGPT since its launch in November 2022. As ChatGPT grows so…
Itâs unlikely that Bob Dylan was writing about the trial master file in his 1964 hit song, âThe Times They Are a-Changin”. And yet, 59…
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two new Good Distribution Practice (GDP) guidance documents that came into force in Feb 2023 The documents…
The FDA has released its BIMO inspection metrics for year 2022. These metrics give you useful information on inspections performed throughout 2022 and observations raised…
GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate…
The EU is introducing more time to certify certain medical devices under EU Medical Device Regulation (âEU MDRâ). The proposal recognises the challenges in capacity…
Large Language Models (LLMs), including ChatGPT and Bard, offer great potential to mimic human conversation. LLMs only directed toward general purposes and whose developers make…
The ECA has published a new guide to illustrate the generally applicable requirements for the design of GMP equipment and to explain how the connection…
Products classified as medical devices must demonstrate they meet the requirements of UK Medical Devices Regulations. The purpose of these regulations is to ensure the…
The MHRA has published its GCP Inspections Metrics Report covering the period 1st April 2019 to 31st March 2020. Perhaps of interest to HSRAA members are…