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The FDA is offering drugmakers the opportunity to become involved in an agency effort to find ways to evaluate quality management maturity (QMM) by using a prototype assessment protocol. Read More
The FDA launched a new search function on its website, designed to help users search for pharmaceutical quality-related guidances, compliance programs and manuals of policies and procedures (MAPP). Read More
Despite overall industry support for the FDA’s development of a voluntary Quality Management Maturity (QMM) program for establishments manufacturing drugs, stakeholders raised concerns about a lack of details and the level of transparency of report findings. Read More
The manufacturer of eye drops linked to more than 80 adverse reactions, including 14 cases of blindness and four deaths, received a 15-page FDA warning letter calling the company out for lack of product sterility as well as inadequate product formulation, data integrity lapses and more. Read More
With the quality metrics movement resurfacing and CDER’s quality maturity model publication in the news, lately I have been giving much thought to what quality culture means and how to recognize a strong culture of quality in a pharmaceutical facility. Read More
While it might seem obvious, achieving effective corrective and preventive action (CAPA) plans requires diligence and consistent application of three core elements. Read More
Eli Lilly has filed lawsuits against 11 online pharmacies that are importing, selling and distributing products purported to contain the active ingredient Lilly’s blockbuster glucagon-like peptide-1 (GLP-1) receptor agonist Mounjaro (tirzepatide), a type 2 diabetes drug that’s expected to be approved soon for weight loss. Read More