1. Principles of Good Laboratory Practice and Reliability Requirements
Lecturer: Eliezer Solomon
Phone No: Fax No:
Cellular No:
מרצה : אליעזר סולומון M.Sc,
טלפון מס':
פקס מס':
פלאפון מס': דוא"ל:
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

2. הכבשה דולי
Eli.S
Lec. No. 1

3. 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

4. Eli.S
Lec. No. 1

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

6. Eli.S
Lec. No. 1

7. Eli.S
Lec. No. 1

8. Eli.S
Lec. No. 1

9. Eli.S
Lec. No. 1

10. Eli.S
Lec. No. 1

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

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

13. 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

14. 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

15. 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

16. 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

17. 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

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

19. 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

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

21. 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

22. 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

23. 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 (2002)
- expanded from ISO to include requirements for quality and competence of Medical Testing Laboratories
Eli.S
Lec. No. 1

24. 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
BIMO Compliance Program Guidance A: GLP Program
Eli.S
Lec. No. 1