Safety Testing

Question 1

Good Laboratory Practice (GLP)

Answer 1

To ensure the quality and integrity of data relating to non-clinical studies undertaken to demonstrate the health or environmental safety of new chemicals or biological substances.
Relates to: pharmaceuticals, industrial chemicals, cosmetics etc.
Used worldwide and incorporated into national regulations (FDA)

Question 2

QA Accreditation scheme

Answer 2

Ensures that the safety of chemicals and biological substances:
-Is carried out correctly
-Results can be relied upon
-Prevent submission of fraudulent data
-International acceptance of data

Question 3

GLP Regulations

Answer 3

Framework for:
-Planning
-Performance
-Monitoring
-Recording
-Reporting
-Archiving

Question 4

ISO 17025 vs GLP

Answer 4

ISO 17025:
- Testing and calibration; repetitive
-Lab accredited to perform specific tests
-Described in a Quality Manual
-Describes responsibilities in general terms
-Storage requirements to comply with local legal requirements
-Proficiency testing to verify methods
-Documented complaints procedure

GLP:
-Generally Single studies
-Lab accredited but not to specific tests
-Described in SOPs
-Sets out specific responsibilities
-Specific storage, retention and archiving requirements
-No requirement for proficiency testing
-Issues addressed through the Law

Question 5

GLP Grading

Answer 5

Critical deficiency: A deficiency which has resulted or will result in the test facility or part of it, or a study or part of it not being in compliance with the principles of GLP.

Major deficiency: A deficiency if not addressed immediately may lead to a facility, system or study being out of compliance. A failure of one of the basic GLP quality systems.

Other deficiency: A departure from the principles of GLP which is not considered critical or major, or is an isolated incident.

Question 6

Following inspection, what occurs?

Answer 6

The lab is given a verbal summary of the findings, and allowed an opportunity to correct any misunderstandings.
Post inspection within 15 working days.
The Lab responds with an action plan that details:
-Timelines
-The corrective and preventative remedial actions, implemented or proposed to address the deficiencies and prevent them happening again.

Question 7

Regulatory or enforcement action

Answer 7

If there are serious concerns relating to GLP compliance:
-Suspend the membership of the UK GLP compliance programme.
-Disqualify the GLP status of specified studies.