Article by BCG Senior Consultant, Michael Trapani, MS, MBA If one takes a close look at the type of Warning Letters issued by FDA over the past twelve months, you may be surprised to learn that approximately 90 letters cited failures of quality systems. Although most of the letters were issued by CDRH citing violations of Quality Systems requirements for medical devices (21 CFR Part 820), CDER and CBER compliance letters notably cited similar concerns regarding quality systems failures from cGMPs specified in 21 CFR Part 211 for drugs and biologics. Why is FDA focusing on quality systems? Since 2002, when FDA unveiled its new initiative to enhance and modernize the regulation of pharmaceutical manufacturing and product quality, it recognized that a well-designed and effectively implemented quality system should reduce or prevent defective products (drugs and biologics) from entering the marketplace while at the same time enabling companies to develop products more efficiently (reduced developmental time and cost.) Modern quality systems models enable companies to have better control of manufacturing process performance by helping to identify and address areas of potential process weaknesses (e.g. sources or quality of raw materials) for continuous improvement and overall better product quality. So, why have FDA compliance inspections resulted in so many Warning Letters? One of the main reasons is that many small or start-up biopharmaceutical or medical device companies do not have the resources or experience in designing modern product development and quality systems. Additionally, they may not have a good understanding of how these systems should be designed for different stages of product development. For example, FDA has different expectations for corrective/ preventive action (CAPA) systems or change controls systems for products in Phase I versus Phase III clinical development. How can BCG help? BCG consultants are experts in the assessment and the development of compliant quality systems. Since our consultants have extensive experience in performing FDA compliance inspections and implementing quality assurance and quality management systems, we are uniquely qualified to assist companies by tailoring the quality system to a particular product and phase of development.
|
