Clinical laboratories that implement web-based software solutions are able to save valuable resources and time but they must be able to demonstrate that their quality systems are safe and effective. The Clinical Laboratory Improvement Amendments (CLIA) were established to regulate and provide quality assurance of human specimens in clinical laboratory environments in order to ensure accurate and reliable test results. Approximately 244,000 laboratory entities are subject to CLIA regulations, which are directed by the Centers for Medicare & Medicaid Services (CMS).
GXP is a general term that refers to Good Practice quality guidelines and standards such as Good Clinical Practice, Good Manufacturing Practice, Good Clinical Practice and so forth. Manufacturers in a variety of industries are acutely familiar with the term and the requirements of GXP quality standards. More and more frequently manufacturers are turning to electronic quality management systems to better meet the demands of GXP regulations and maintain a competitive edge in the global marketplace. Electronic quality management systems can dramatically streamline GXP compliance and subsequently get manufacturers’ products to market sooner.
GAMP® 5 is the most current iteration of the Good Automated Manufacturing Practices defined by the International Society for Pharmaceutical Engineering (ISPE). The principles and procedures set forth in GAMP® 5 help ensure that automation equipment meets quality standards. Quality by design (QbD), one of the fundamental directives of GAMP® 5, advocates that quality should be built into each stage of the manufacturing process. Compliance with GAMP® 5 standards provides an assurance that manufacturers’ machines are designed and constructed within an all-inclusive total quality management system. GAMP 5 compliance requires methodical process steps, rigorous testing and accurate documentation in order to validate specifications.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) unites the pharmaceutical industry with the regulatory authorities of Europe, Japan and the United States for the purpose of coordinating the scientific and technical aspects of drug registration. ICH’s Good Clinical Practice (GCP) guidelines describe the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and institutional review boards (IRBs). The multilateral ICH guideline was finalized in 1996 and covers aspects of monitoring, reporting and archiving of clinical trials.
FDA 510(K) AND PMA SUBMISSIONS
Prior to marketing a medical device, manufacturers must demonstrate to the FDA that the device to be marketed is safe and effective. New devices must be categorized and proven to be substantially equivalent to a legally marketed device that is not subject to premarket approval (PMA). To ensure such conditions are met, Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market such devices at least 90 days in advance. Given these rules, device manufacturers must first implement sufficient quality and change control practices in order to receive 510(k) clearance without any stumbling blocks. Inexact communication about device changes or modifications can have a significant negative impact on product safety and/or effectiveness and will likely slow the time it takes to get the product to market.