What Are The Contents Of The 21 Cfr Part 58 For Glp?

1.	What Are The Contents Of The 21 Cfr Part 58 For Glp?
Answer» Scope Definitions Applicability to studies performed under grants and CONTRACTS Inspection of a testing facility Personnel Testing facility management Study director Quality assurance unit General Animal care facilities Facilities for HANDLING test and control articles LABORATORY operation areas Specimen and data storage facilities Equipment design Maintenance and calibration of equipment Standard operating procedures Reagents and solutions Animal care Test and control article characterization Test and control article handling Mixtures of articles with carriers Protocol Conduct of a non-clinical laboratory study Reporting of non-clinical laboratory study results Storage and retrieval of records and data Retention of records Purpose Grounds for disqualification Notice of and opportunity for HEARING on proposed disqualification Final order on disqualification Actions upon disqualification Public disclosure of information regarding disqualification Alternative or additional actions to disqualification Suspension or TERMINATION of a testing facility by a sponsor Reinstatement of a disqualified testing facility.

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