Principles of Good Laboratory Practice and Reliability Requirements Lecturer: Eliezer Solomon Phone No: Fax No: Cellular No: E-mail: מרצה : אליעזר סולומון M.Sc, טלפון מס': 3104309-77 פקס מס': 3104209-77 פלאפון מס': 050-7820966 דוא"ל: eli_sol@bezeqint.net מומחה לבדיקות אנדוטוקסין ומהנדס איכות. ניסיון של 26 שנות עבודה בתעשייה הביוטכנולוגית. חבר בASQ , ISQ, וIES - . יועץ, מרצה וכותב בתחומי האיכות. Eli.S Lec. No. 1

הכבשה דולי Eli.S Lec. No. 1

פתרון בעייה רפואית ע"י יישום ידע ביולוגי פתרון בעייה רפואית ע"י יישום ידע ביולוגי ננסות ילדים איסוף מידע פתרונות אפשריים תהליך ביוטכנולוגי/כימי בעייה חדשה פתרון הבעייה Eli.S Lec. No. 1 Lect. No. 1 Eli Solomon

Eli.S Lec. No. 1

עריכה ושחבור שינויים שלאחר התרגום Eli.S Lec. No. 1

Eli.S Lec. No. 1

Eli.S Lec. No. 1

Eli.S Lec. No. 1

Eli.S Lec. No. 1

Eli.S Lec. No. 1

What is the GLP ? Eli.S Lec. No. 1

GLP GLP = Good Laboratory Practice OECD Principles on Good Laboratory Practice What is the OECD ? Eli.S Lec. No. 1

OECD = The Organization for Economic Co- operation and Development Intergovernmental organization 30 industrialized countries Meet to co-ordinate and harmonize policies. Discuss issues of mutual concern Work together to respond international problems. Eli.S Lec. No. 1

Industrialized 30 Countries Australia Austria Belgium Canada Czech Republic Denmark Finland France Germany Greece Hungary Iceland Ireland Italy Japan Korea Luxembourg Mexico Netherlands New Zealand Poland Portugal Slovak Republic Spain Sweden Switzerland Turkey UK USA Norway Eli.S Lec. No. 1

מטרת GLP Purposeny The principle of Good laboratory practice (GLP): To promote (( לקדםthe development of quality and validity of test data used for determining the safety of chemicals and chemicals product. Eli.S Lec. No. 1

GLP Definition GLP is 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. Eli.S Lec. No. 1

Why GLP ? Development of quality test data Mutual acceptance of data Avoid duplication of data Avoid technical barriers to trade Protection of human health and the environment Eli.S Lec. No. 1

סוגי מעבדות מחקר Research קליני רפואי (בני אדם) Clinical לא קליני (בעלי חיים) Non Clinical סביבתיות Ecological Eli.S Lec. No. 1

Terminology of a GLP organisation and מושגים ומונחים test facility Test site Multi-site study Sponsor מימון ממשלה, חברת תרופות, אקדמיה, תרומה Study director (SD) מנהל המחקר Principal investigator (PI) חוקר ראשי Quality assurance (QA) Standard Operating Procedures (SOPs) Master schedule of studies לוח זמנים Eli.S Lec. No. 1

סוגי בדיקות הדורשות - GLP Pharmaceutical product Pesticides product Cosmetic product Food additives Industrial chemical Eli.S Lec. No. 1

Type of tests סוגי בדיקות Physico-chemical properties (pH, density, OD) Toxicological studies designed to evaluate human health effects (LD 50) Eco-toxicological studies designed to evaluate environmental effects (Pesticides, Pthalates,  Asbestos PB, Hg) Ecological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation) Eli.S Lec. No. 1

Role of Laboratories in Medicine משמעות המעבדה ברפואה Medical Testing Laboratory patient care clinical drug trial Research Laboratory discovery & development of new drugs / therapy fundamental research / mechanisms of diseases Manufacturing post clinical trials, bulk drugs, cell-based therapy, plasma products, medical device Eli.S Lec. No. 1

Standards for Laboratory involved in Clinical Studies תקנים לעבודת המעבדה Accreditation ((אישור to ISO 17025 - requirements for the competence (הסמכה) of testing and calibration laboratories Accreditation to ISO/IEC 15189 (2002) - expanded from ISO 17025 to include requirements for quality and competence of Medical Testing Laboratories Eli.S Lec. No. 1

GLP - Reference Documents & Links www.fda.gov/cder 21 CFR 58 – Good Laboratory Practice for Non-clinical Laboratory Studies Div. of Scientific Investigations: Good Laboratory Practice www.fda.gov/cder/Offices/DSI/goodLabPractice.htm BIMO Compliance Program Guidance 7348.808A: GLP Program www.fda.gov/ora/compliance_ref/bimo/7348_808A/Default.htm Eli.S Lec. No. 1