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An Apotex Research facility in Bangalore, India was cited for non-compliance with GMP requirements after an inspection in November by the UK’s Medicines and Healthcare products Regulatory Agency revealed non-sterile conditions, packaging issues, and inadequate testing. Read More
The FDA flagged facilities in Italy, India and China for noncompliances including inadequate testing, complaint handling, and quality data, among other violations. Read More
The FDA issued warning letters to eight drug manufacturers for adulterated products, misbranding and unapproved drug products, among other violations. Read More
The FDA released a draft guidance for the development of drugs that use nanomaterials, emphasizing that quality, efficacy and safety of products containing nanomaterials can be sensitive to the production environment and manufacturing process. Read More
ORA and CDER officials provided an update last month on the agency’s Concept of Operations initiative in a panel discussion at the FDLI Enforcement Litigation and Compliance Conference in Washington D.C., detailing the next steps in implementing the concept. Read More
In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More
Quality experts and FDA officials predict 2018 will bring more streamlined FDA inspections and a greater focus on digital records and data integrity, as the agency implements its ambitious Concept of Operations initiative. Read More