The international standard of GLP or Good Laboratory Practice is a data and quality management system used to promote the quality and validity of test data. GLP has been created to guarantee the quality, consistency and reliability of data which has been generated and accumulated through laboratory studies. It embodies a set of principles (OECD, FDA, EPA) that provide a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived.
On completing this Good Laboratory Practice (GLP) training course, the participant will:
- Become familiar with the principles and significance of GLP, and
- Be able to apply these principles successfully in a laboratory setting so that the laboratory in question is GLP compliant,
- Be able to correctly analyse, interpret and report laboratory data (provided during the 2 day course only).
This course is based on the OECD GLP Principles, which are recognized as the international standard for Good Laboratory Practice. All GLP texts, irrespective of their origin, stress the importance of the following five points:
- Resources. Management, Personnel, Facilities: Buildings and Equipment,
- Characterization. Test and reference items, and Test systems to which the test and reference items are to be administered,
- Rules. Protocols (Study Plans), Standard Operating Procedures (SOPs),
- Results. Raw data, Final Report, Archives,
- Quality Assurance. Audit/ Inspection, Training, Advice.
Each of these five points will be discussed in detail during the course as they relate to Good Laboratory Practice. Analysis of laboratory data will include calculation of measurement uncertainty and statistical analysis. Similarities and differences between GLP and the international standard ISO/IEC 17025:2005 used in the accreditation of commercial testing and calibration labs will be discussed. Throughout the course, worked examples and practical case studies will be used to help delegates apply GLP requirements and responsibilities with regards to personnel, facilities, equipment, test systems and record storage.
Laboratory Managers/Supervisors, Analysts, Technicians, Research Scientists, Post-graduate Students, Quality Assurance staff, Auditors, Technology Transfer Officers, and anyone who wishes to increase their understanding of Good Laboratory Practice.
The 2-day Implementation of ‘Good Laboratory Practice’ course promoted by Biologic was extremely useful to our company. Last May, we started to run an in-house microbiology laboratory. Prior to that, the company had a lot of analytical chemistry being done in-house, which then continued to be done with the microbiology. Although the results produced by the lab were satisfactory, the demand for results increased, and with that, the data, protocols and routines needed to be managed and retrieved. We needed to control this information and routines in a more systematic way. From our first contact with Douglas and Karine we got good explanations about how the GLP training would help us to achieve this aim.
Our training took place in October 2014. Our expectations were all met during the course which was well-structure and comprehensive. We received, for example, definitions of both GLP and ISO 17025:2005 and also recommendations to which category our lab fitted better. We were able to bring doubts in how to improve/correct our current management system. We discussed how to keep control of orders and reagents, equipment, and how to organise a myriad of relevant documentation, and also how to lead technical staff, etc. The knowledge of GLP also helped us to improve our feedback to our managers as regards the need of certain approaches needed in the laboratory.
Douglas offered us a customised and interactive training, which we appreciated.
I would certainly recommend it to laboratory/scientific leads in industry working to generate reliable results.
Dr. Ana Carolina M. de Almeida – Compliance Officer/Head of Microbiology – RainSafe Water