Safety testing of drugs can be a contentious issue – testing of non-pharmaceuticals is even more so. Opinions are especially polarised where the test systems are live animals. Understandably, such practices are tightly controlled, and this is where Good Laboratory Practice plays a vital role.
In 1976, the FDA issued the first draft of the regulations that would become known as GLP. This was largely prompted by alarming findings at a US testing lab that, at the time, carried out almost half of the world’s toxicology tests.
The OECD GLP principles came a little later and form the bedrock of toxicology and environmental studies, having been passed into the legislation of many countries. The OECD defines GLP as “…a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.”
The principles are wide ranging – as the work covered varies enormously from those involving chemical tests carried out in a lab to large-scale field trials. Whitehall Training has just published an online training course that deals with each of the following important aspects:
- The History & Purpose of GLP – how the GLP principles were produced and the key role they play…
- Test Facility Organisation & Personnel – organisational processes required, and how the GLP requirements for the responsibilities of various staff can be delivered in practice…
- Quality Assurance – how SOPs, the study plan and master schedule are used to provide an independent audit function…
- Facilities – the requirements for test systems, reference and test item handling and archives…
- Apparatus, Materials & Reagents – the steps need to ensure that apparatus, materials and reagents are all fit for purpose…
- Test Systems – the practical rules governing living and non-living systems especially identification, health and prevention of contamination…
- Test & Reference Items – the methods for the receipt, handling and storage of test and reference items…
- Standard Operating Procedures – what SOPs should cover, how they should be used, and what to do when deviations occur…
- Performance of the Study – the study plan, how to accommodate amendments and deviations, and the requirements for raw data…
- Reporting of Study Results – the content and format of the study report and dealing with requests for additional work…
- Storage & Retention of Records & Materials – submitting to archive, retention periods, disposal and dealing with electronic data…
- Additional OECD GLP Consensus/Advisory Documents & Position Papers – specific rules covering suppliers, field studies, short-term studies, computer systems, sponsors, multi-site studies and in vitro studies
- GLP Programmes – the role of national GLP monitoring programmes and the three inspection types…
- Mutual Acceptance of Data – the MAD programme, intended to reduce unnecessary duplication of testing…
Like all of Whitehall’s training, the GLP course has a multiple-choice exam and a uniquely-numbered, named and dated certificate that can be used to demonstrate training compliance at audit. It has also been accredited with 6 CPD points by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.
About the author…
Roger Chapman is an internationally recognised expert in the interpretation and application of OECD Good Laboratory Practice to the full spectrum of regulatory studies, both in the laboratory and in the field. He also has extensive experience of Good Clinical Practice in the laboratory (GCLP), and Good Manufacturing Practice in the Quality Control laboratory environment.
A long-serving former Senior Quality Assurance Manager in the Contract Research industry, Roger has developed a tremendous depth of experience in compliance problem-solving. He has also led or participated in over 70 regulatory inspections from the MHRA, FDA and EPA, and has developed and maintained GxP quality systems and audit programmes for over 30 years.
Roger is a regular speaker at regional, national and international conferences and an established trainer/facilitator on professional development courses covering Quality, Compliance and Quality Assurance.
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