This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.
The clinical trials enterprise has long assumed that when it comes to ensuring trial quality, data is king and more is better. Not only was it considered essential to gather detailed data on every aspect of a clinical trial, but that data had to be double-entered, checked, queried, cleaned, and validated.
On-site cGMP audits are an important part of creating and maintaining a compliant, reliable, and secure supply chain that safely provides high-quality clinical and commercial drug products when and where needed. An important auditing decision is whether to use an individual or pooled audit.
This article will address the expected roles of quality control and quality assurance, how these roles are related and how they are different, and how they must work together to create a sound quality management system (QMS).
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.
In today’s fast-paced environment, everything needs to be done right the first time. This is especially important when releasing pharmaceutical and biological products to the market. To accomplish this, firms employ a special group of quality professionals, called the batch review/release group, to review executed batch records and be that all-important final sign-off for release to market. This is no easy task. Much of the time, these executed batch records are many pages long with complex information and data to review for accuracy. Effective and efficient management of this review process is the key to a successful process.
This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements.
Developing products in the life sciences industries is complex. Basic quality tools can be used to bring the complexity into focus and help streamline the development strategy. These tools can help identify your primary goals and assess potential risks and failure modes to enable agile thinking early in development, where experimental outcomes often indicate the need to alter your development strategy.
Despite quality audits and third-party oversight, contamination of prescription and over-the-counter (OTC) pharmaceutical products is still prevalent. This is despite the adoption of cGMP practices, SOPs, risk mitigation methods, and metrics such as key performance indicators. We evaluated various emerging practices to overcome contamination issues. Novel batch concentration tests and dedicated capacity utilization have proven to overcome the source of contaminants. For technology adoption in continuous manufacturing, which is unclear in terms of compliance, the FDA Emerging Technology Team could be used for advisory oversight.