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 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

3. 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

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