QSR and GLP What exactly are these?

Key Terms QSR: Quality System Regulations Standard produced by the FDA which companies MUST follow Include standards such as training, document control, process control, design control GLP: Good Laboratory Practices Prescribes practices for conducting non clinical lab studies that support or are intended to support applications for research or marketing of regulated products. Required for research applications to be submitted to the FDA Intended to assure the quality and integrity of safety data filed Does not include human studies or clinical studies

QSR See the standard handout cGMP and QSR are essentially the same You need to understand and recognize what these standards are all about Training Management Responsibility Design Control Process Control Inspection, Lot traceability cGMP and QSR are essentially the same Mandated by FDA; only in US ISO is very similar except it is …. Voluntary and is recognized worldwide

Good Laboratory Practice 21 CFR PART 58 Intended to support applications for research or marketing permits for products regulated by the FDA Including food and color additives Including animal food additives Including toxic drugs Including medical devices for human use Including biological products and.. Including electronic products Not used for basic research

Examples of what’s included Good lab practices Labeling reagent bottles w/ proper info. Reagent name, date, initials or name of who prepared it Equipment monitoring Calibrated, cleaned and verification logs Written procedures Filled out, reviewed by QA, and maintained Personnel should be qualified or at least knowledgeable