QSR and GLP

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
• 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 whats 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