GLP Principles Implementation in the Biological Testing Laboratory of RAS

Transcription

1 2012/SOM2/SCSC/CON/018 GLP Principles Implementation in the Biological Testing Laboratory of RAS Submitted by: Russian Academy of Sciences (RAS) 9 th Conference on Standards and Conformance in the Field of Innovations and Related Good Practices Kazan, Russia May 2012

2 GLP PRINCIPLES IMPLEMENTATION IN THE BIOLOGICAL TESTING LABORATORY OF BIBH RAS Myrashev Arkadii Nikolaevich Biological testing laboratory Branch of Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry Russian Academy of Sciences GLP STANDARDS INTERNATIONAL STANDARD «OECD Principles on Good Laboratory Practice» (OECD, ENV/MC/CHEM(98)17, 1997.) NATIONAL STANDARDS RF. «Principles on Good Laboratory Practice» (GOST R ) USA. Good Laboratory Practice for Nonclinical Laboratory Studies (FDA, 21 CFR Part 58, 22 of december 1978.) information monitoring 1

3 GLP PRINCIPLES (GOST R ) 1. Test Facility Organization and Personnel 2. Quality Assurance Programme 3. Facilities 4. Apparatus, Material, and Reagents 5. Test systems 6. Test & Reference items 7. Standard operating procedures 8. Performance of the Study 9. Reporting of Study Results 10. Storage and Retention of Records and Materials Test facility / Test site The actual location for conducting of the non clinical testing (individual stages), including Personnel Premises Equipment 2

4 PERSONNEL S RESPONSIBILITIES Personnel must Know the principles of GLP. Have access to the study plan and appropriate Standard Operating Procedures. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the Study Director. Record raw data promptly and accurately. Exercise health precautions to minimise risk to themselves and to ensure the integrity of the study. REQUIREMENTS FOR TEST FACILITIES Size, construction and location of facilities must meet the aims of the study 3

5 HARDWARE REQUIREMENTS Apparatus used in a study should be suitably located and of appropriate design and adequate capacity. Apparatus used in a study should be periodically inspected, cleaned, maintained and calibrated according to Standard Operating Procedures. All performed tests must be accompanied by appropriate records BIOLOGICAL TEST SYSTEM Proper conditions should be established and maintained for the storage, housing, handling and care of biological test systems, in order to ensure the quality of the data. Physical Chemical Biological Social 4

6 TEST SYSTEMS REQUIREMENTS At the experimental starting date of a study, test systems should be free of any disease. SPF Animals (Specific Pathogen Free) Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) AAALAC (American Association for Accreditation of Laboratory Animal Care) was established in created in Nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. Organization s application (Guide for the Care and Use of Laboratory Animals) Report of the results of inspections by AAALAC experts 5

7 ORGANIZATION SCHEME OF TESTING IN LINE WITH GLP Test Facility Management sponsor study director brief description of the study application to the bioethical commission plan (protocol) of the study study plan (protocol) approval Meeting with personnel Study transfer the materials to the archive report Quality Assurance Unit 6

8 THANK YOU FOR YOUR ATTENTION! Myrashev Arkadii Nikolaevich 7