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 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