Good Laboratory Practices (for Non-Clinical Laboratories)

Aims:
To provide an introduction to the regulations and Codes of Practice that govern facilities engaged in toxicology and product safety testing, primarily in animals and biological test systems, and to develop a broad understanding of the scope of Good Laboratory Practices and Quality Management Systems.

Outline Syllabus: 

• GLP Principles
• History of GLP
• International GLPs
• The responsibilities and functions of management, Study Director, Principal Investigator
• The responsibilities and functions of the Quality Assurance Unit
• Standard Operating Procedures
• Study Plans and Protocols
• Facilities and Equipment
• Test articles and test systems
• Records and Reports, Archiving
• Working with CROs
• Regulatory Audits

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• List the scope of FDA control.
• Describe the regulatory review process for registrations and GLP/GMP compliance.
• Describe the role of the QA Unit in a GLP laboratory
• Understand the content and intent of 21CFR 58 and OECD Good Laboratory Practices.
• Compare and contrast the requirements of 21CFR 58 and OECD Good Laboratory Practices
• State the required contents of a study protocol.
• State the required contents of a study report.
• State the requirements for securing and protecting data.

(2) Discipline skills

• Prepare Study Protocols
• Audit study protocols and reports against GLP requirements
• Prepare SOPs that comply with GLP requirements