1 / 5

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

Download Presentation

QSR and GLP

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related