Introduction To ASTM E3263-20:
By Andrew Walsh, Ralph Basile, Ovais Mohammad, Stéphane Cousin, Mariann Neverovitch, and Osamu Shirokizawa
Part of the
series
Visual inspection has been widely used for many years by the pharmaceutical, biologics, and medical device industries after cleaning to release manufacturing equipment and devices. However, visual inspection has never been demonstrated to be an effective, reliable, or safe method to use for these inspections. Recently, the European Medicines Agency (EMA) issued a Q&A
1 to its guideline on determining health-based exposure limits (HBELs) that describes what criteria have to be met for visual inspection to be acceptable to the EMA for release of manufacturing equipment. Some form of guidance or a standard has been needed to guide these industries on how to meet these criteria and demonstrate that operators/QA inspectors are capable and qualified to accurately assess the absence or presence of residues on manufacturing equip
IFC, Jordan partner to open new markets for food, pharmaceutical companies
By JT - Dec 23,2020 - Last updated at Dec 23,2020
AMMAN IFC, a member of the World Bank Group, partnered with Jordan’s Food and Drug Administration to help Jordanian farmers, food producers and pharmaceutical companies increase exports and expand into foreign markets.
The partnership is designed to create jobs and support economic growth, according to a statement posted on the IFC website.
IFC will advise Jordan’s FDA on improving its inspection regime, adopting international food safety standards, creating harmonised manufacturing standards for medicine and strengthening national guidelines governing the food and pharmaceutical industries.