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QSR and GLP

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

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QSR and GLP

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  1. QSR and GLP What exactly are these?

  2. 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 clinicallab 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

  3. QSR • See the standard handout • 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

  4. 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

  5. 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

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