The US Food and Drug Administration (FDA) is extending the deadline to comply with unique device identifier (UDI) requirements for certain Class II devices. The first mandate posted was that all Class II devices must be in compliance by September of 2016. Now, FDA says it is extending the compliance date for certain Class II […]
The European Commission (EU) announced its latest revisions to the proposed rule changes for unique device identification (UDI) requirements. The agreement has been in the development stage for the past year and the EU has now developed tighter rules for medical manufactures. These rules center on areas such as trace-ability and are designed to ensure […]
Quality system audit schedules are typically published at the beginning of each year; however, internal auditing personnel may find themselves unprepared when actual audit dates approach. In such instances, companies undertake last minute preparations of checklists and audit questions that generally take months to develop. This can lead to a rushed audit process where corrective […]
The Association for packaging and processing technologies, examined the latest trends impacting the pharmaceutical market. Global sales in 2016 have reached a record high for pharmaceutical sales at $1.1 Trillion, with North America alone generating $574 billion. The greatest influence on growth in the pharmaceutical industry is general economic development. As more people can afford […]
The Drug Supply Chain Security Act – DSCSA (Title II, Drug Quality and Security Act, 2013) has been signed into law, with full implementation phased in over the next 10 years. The next milestone for manufacturers is November 27, 2017; the date by which Pharmaceutical manufacturers are required to print a unique product identification […]
Companies worldwide are challenged with developing and maintaining efficient disciplined product labeling. They are tasked with a wide range of internal requirements, Marketing and Product Branding and external regulatory requirements, such as GHS or UDI compliance requirements. As example, the chemical industry and their respective supply chains are continuously evolving and have as complex a […]
The first compliance date for Unique device identification, UDI, class III was September 2014. Class III medical devices are defined as devices that support or sustain human lives, Class III Medical Devices include implanted pacemakers, heart valves and implanted cerebral simulators. At that time the FDA mandated that labels and packages of class III medical […]
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