GLP (Good Laboratory Practice) is a quality system that sets rules for how laboratory research and testing should be done, especially in pharmaceutical and medical industries. Think of it like a strict recipe book that scientists must follow to ensure their work is reliable and safe. When companies mention GLP in job descriptions, they're looking for people who understand and can follow these important safety and quality rules. This system helps make sure that when medicines are developed, all the testing is done properly and can be trusted by regulatory agencies like the FDA.
Conducted drug safety studies following GLP guidelines
Managed GLP compliant laboratory operations for preclinical testing
Led team of scientists in GLP regulated research facility
Implemented Good Laboratory Practice (GLP) standards in research protocols
Typical job title: "GLP Scientists"
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Q: How would you handle a significant GLP compliance deviation in a critical study?
Expected Answer: A senior professional should explain the process of documenting the deviation, assessing its impact, implementing corrective actions, and possibly notifying regulatory authorities if required. They should also discuss preventive measures for the future.
Q: How do you ensure GLP compliance across multiple research teams?
Expected Answer: Should discuss developing standard operating procedures, training programs, regular audits, documentation systems, and methods for maintaining consistency across different teams and projects.
Q: What documentation is required for GLP compliance?
Expected Answer: Should be able to explain the importance of standard operating procedures (SOPs), study protocols, raw data records, final reports, and personnel training records.
Q: How do you maintain equipment calibration records in a GLP environment?
Expected Answer: Should describe the system for tracking equipment maintenance, calibration schedules, documentation requirements, and the importance of proper record-keeping.
Q: What are the basic principles of GLP?
Expected Answer: Should be able to explain basic concepts like proper documentation, following protocols, equipment maintenance, and the importance of accuracy in record-keeping.
Q: How do you properly document changes or corrections in GLP studies?
Expected Answer: Should explain the proper way to make corrections (single strikethrough, initial and date, reason for change) and why maintaining data integrity is important.