With the COVID-19 vaccine in the headlines on an almost daily basis and the need to speed up distribution, rivals Merck and Johnson and Johnson will work together to produce the J&J single-dose vaccine. Read more. Compliance within the pharmaceutical field is intense, add a “highly complex” manufacturing process for this vaccine and an outsider […]
In mid- January, a juice production company came under fire by the FDA due to contaminated product. During the inspection, the FDA found that they had “failed to adhere to relevant food safety standards”. Some of the distribution of this juice included school lunch programs. When looking at the importance of compliance, labeling plays a […]
The purpose of the guidance is to allow food manufacturers to use the name “potassium salt” on food labels as alternative to the common name, “potassium chloride”. This salt alternative is formulated to reduce sodium content. This alternate name also makes it more clear the consumer as to what this item is. This guidance supports […]
Here are some examples of the requirements for labeling in Food & Beverage Examples: The FDA’s Food Safety and Modernization Act (FSMA), aimed at preventing food contamination across every step of the supply chain, including use of imports and exports across international boundaries. FSMA also gives the FDA authority to order a mandatory recall of […]
UDI requirements for class 3 and class 2 devices are now behind you, but the compliance standards continue to emerge and you must maintain the ones you have already completed. Maybe your organization is impacted by all three (3) UDI class distinctions, or MDR (European UDI) standards, or you have additional requirements to maintain these […]
Last week we discussed the extension the FDA has granted on the Unique Device Identifier (UDI) Class II Mandates. Similar to the extension there are also exceptions on single use devices that medical manufactures should be aware of. The exception states that if you put a (UDI) on the next higher level of packaging you […]
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 […]