OVERVIEW OF GLP REGULATIONS Mercy Okezue The Birth
OVERVIEW OF GLP REGULATIONS Mercy Okezue
The Birth Of GLP -In the early 1970 s, the FDA investigated a number of cases of poor practice in toxicology laboratories throughout the USA - Results of this investigation in about 40 laboratories revealed many cases of poorly managed studies, insufficient training of personnel, and some cases of deliberate fraud - In 1976, the FDA published a draft regulation on GLP - After the consultation period, the final regulation was published in 1978 - This came into force in 1979 - Many countries introduced their own GLP Regulations - The OECD produced GLP Principles in 1981. These regulations have now become the international standard in the domain
WHAT IS GLP? • Defined in the OECD Principles as: “. . . a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. ”
GLP Aims 1 2 3 To make incidence of False Negatives more obvious To make incidence of False Positives more obvious To promote mutual recognition of study data across international frontiers (False negative : Results demonstrate non-toxicity of a toxic substance) (False positive : Results demonstrate toxicity of a non-toxic substance)
MAIN / FUNDAMENTAL POINTS IN GLP CONSIDERATIONS • Organization, personnel, facilities - building and equipment Resources Rules • Protocols / Study plan, SOPs • concept of the Study Director as the pivotal point of study control • Test items & test systems Characterization • Raw data, final report, archives. Documentation • Independence from study conduct Quality assurance
RESOURCES Buildings: Adequate Separations • Physical separations: üRooms üCabinets / Isolators üAir systems and filters • Separation by work areas üDefined work areas üOne-way systems üDifferent activities in same areas at different times üCleaning between activities üSeparate staff GLP WHO Training manual
CHARACTERIZATION Test Item • GMP is not required for manufacture of GLP batches • Regulatory Authorities require testing to ensure test items suitability for preclinical studies • Use single lot throughout study if possible • Protect test item from cross contamination/pollution • Ensure traceable records for test items What are Test Systems ? • Animals • Bacterial • Cells • Organs • Plants can also be • Analytical equipment
Rules • The protocol (or study plan) which describes how the study is designed and how it is to be conducted, including the expected timeframe of the study • Approval of the Protocol (study director) • Distribution of the Protocol • Protocol Amendments • The standard operating procedures (SOP) which provide detailed instructions about how to actually perform each technical procedure, and how to ensure sound organization of the study, its environment and data
Documentation: Results • Records and recording - The raw data should include: • FINAL REPORT (study director) • Accurate Reporting and Deviations v. Statement of compliance to GLP standards and validity of data Ø“WHAT was done” Ø“HOW it was done” Ø“WHEN the work was performed” Ø“WHO performed What is Archived? the work” • Study data • Personnel data • Systems data • Quality assurance files
Quality Assurance • In summary, the fundamental mission of QA is that of an independent witness to the whole preclinical research process and its organizational framework • To respect GLP Principles, QA must review all phases of preclinical research - from planning to reporting and archiving of the documentation • To be effective, QA must have access to staff documents and procedures at all levels of the organization, and be supported by a motivated top management • the signed QA statement becomes a “release” document (not a GLP compliance statement)
Further Reading proto. ufsc. br/files/2012/03/glp_trainee_green. pdf https: //www. who. int/tdr/publications/documents/glphandbook. pdf
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