QSR and GLP What exactly are these Key

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 – You need to understand recognize what these standards are all about • • • Training Management Responsibility Design Control Process Control Inspection, Lot traceability • c. GMP 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