This article is the second in a two-part series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems. Part 1 discussed the importance of “top-down” quality management and “bottom-up” communication of compliance risks and concerns. Here in Part 2, we turn our attention to the input data for an effective QMR.
This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Over the last several months, we’ve heard of far too many incidents of sexual harassment or worse coming to light. In the event you’re not familiar with the terms, #MeToo is a hashtag used in social media to demonstrate the prevalence of sexual assault and harassment. It went viral as victims started to post their own stories, showing how widespread the problem actually is. Founded by Hollywood celebrities in response to several high-profile sexual harassment and assault cases in the entertainment industry, the Time’s Up initiative champions change in these behaviors and works to establish fair treatment for all.
FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.
Success in developing a drug product, medical device, or drug substance requires navigating the tradeoffs and decisions of today’s complex global regulatory realm. Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action.
Artificial intelligence (AI) has truly moved from concept to reality in the pharmaceutical industry. Many companies are already using AI to pour through mountains of scientific data in an effort to speed and improve the drug discovery process. And the technology is starting to find new applications in areas as diverse as regulatory/compliance, clinical trials, manufacturing, and supply chain.