Analytical Laboratory KPIs: Turnaround Time (TAT) Test Completion Rate: Accuracy and Precision: Instrument Uptime: Sample Rejection Rate: Quality Control KPIs: Out-of-Specification (OOS) Rate: Out-of-Trend (OOT) Rate: Deviation Rate: Corrective Action/Preventive Action (CAPA) Effectiveness: Read also: Resource Person: Rajesh Jain
This time we focus on a drug manufacturing facility in South Korea, issued a Warning Letter on June 12, 2024 Inadequate Validation of Manufacturing Processes The facility failed to adequately validate manufacturing processes for their over-the-counter (OTC) drug product. This includes insufficient data to demonstrate process validation and equipment qualification. Corrective Actions –…
FDA Adverse Event Reporting System (FAERS) monitors the safety of drugs & biologic products, contains reports of AE & medication errors that have been submitted to the FDA & to take appropriate action, such as updating drug labels/issuing safety communications. Bioequivalence (BE) Recommendations for Specific Products provides guidance on BE studies that helps applicants seeking…
The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies. The following is a list of traditionally recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.(including) Foods Drugs Biologics Medical Devices Cosmetics…
The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation. Company’s website or in commercial promoting a product or treatment some marketers may say their products are “FDA approved.” But how can you…
A Waring Letter (#659142) issued to a US based compounding facility for several serious cGMP violations, including: Several other violations were listed for non-HEPA filtered air, lack of validation of aseptic processes, inadequate cleaning and disinfection, issues with facility design, inadequate environmental monitoring, lack of final product testing and an inadequate stability program. …
Put together an Inspection Team that will be responsible for dealing with the inspection when the FDA is on the premises. The inspection team should consist of: Responsible Person — Select a high-level officer or manager, someone with ultimate responsibility for the company’s compliance. This person could be as high level as the CEO…
If you are a manufacturer or a processor of FDA-regulated products, sooner or later, you can expect a visit from FDA. The purpose of this visit is to verify compliance with all relevant regulations — most commonly referred to as an “FDA inspection.” But not all inspections are created equal. FDA Inspections The four…
