<span class="archive__title-prefix>Posts Categorized:</span> Blog

Cell and Gene Therapy (CGT) is one of the fastest-growing areas of research and development in the healthcare sector internationally. Some of the resulting products have been touted as miracle cures and demonstrated to provide transformative results for some patients. CGT products have been developed to treat a wide range of rare and debilitating diseases […]

Evaluating FDA compliance actions like warning letters and Form 483s is a good way to determine agency expectations and to focus internal evaluations of manufacturing facilities and quality systems. FDA warning letters to finished dose manufacturers include numbered paragraphs with a reference to the specific CFR that is being cited, followed by examples that support […]

The biopharmaceutical and medical device industries are some of the most highly regulated industries in the world. Staying within regulatory compliance can take a lot of work regardless of a company’s maturity or size. As your company expands to the global market, staying compliant and aware of the changing landscape becomes increasingly important for product […]

Are your laboratory practices enabling good data integrity when it comes to your equipment? The following are additional questions submitted following the May 24, 2022 webinar, “Are Laboratories Perpetuating Data Integrity Problems?”, that featured presenters Paul Smith from Agilent Technologies and Consultant Bob McDowall. These questions specifically address laboratory instrumentation. A portion of the Q&A […]

How does FDA decide whether to conduct a biologics manufacturing inspection in person or perform a remote assessment? At the GMP by the Sea annual conference in Cambridge, Md. in August 2022, FDA Office of Pharmaceutical Manufacturing Assessments (OPMA) deputy director Derek Smith explained that the agency makes decisions based on a variety of risk […]

ALCOA(+) – a gift from FDA’s Stan Woolen that continues to add value The following is a guest article by ERA Sciences’ Eva Kelly. BSc Ph.D. FICI. Author’s Note: This article, focuses the data integrity lens on original and accurate data. Also described is the ALCOA+ acronym for readers new to the data integrity topic. […]

Insights from Peter Baker at the 46th International GMP Conference An investigation into data integrity (DI) issues is “almost inevitable” for every company in the industry within about two years, says Peter Baker, former FDA investigator and president of Live Oak Quality Assurance.  Speaking at the 46th International GMP Conference in March, Baker painstakingly detailed […]

What are the current and future anticipated states of biologics inspections regulated by CDER? At the annual GMP by the Sea conference in Cambridge, Md. in August, FDA Office of Pharmaceutical Manufacturing Assessments (OPMA) deputy director Derek Smith provided insight into the inspection landscape of biologics regulated by CDER. [Related: Download our latest report that […]

During the recent pandemic, conducting in-person biologics manufacturing facility inspections has been a challenge and has forced FDA to look for innovative ways to maintain the quality of its oversight of drug manufacturing. In addition to remote assessments and other non-traditional methods to ascertain the quality and compliance of manufacturing facilities, the agency further explored […]

What are the GMP quality and compliance issues FDA leaders are most concerned about? Why is my site undergoing a surveillance inspection only months after a pre-approval inspection? And when should I expect to receive an EIR? In conjunction with Quality Week, Redica Systems is releasing our latest report, “Insights on Quality from FDA Leaders,” […]