1. נמטוציטים משושנת ים
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2. GLP Concerns as Per Schedule Drugs & Cosmetics הדרישות במעבדה
Storage and Archival
General Requirements
Premises
Raw Data
Personal
Protocols and
Specifications Archive
Equipments
GLP
Chemicals and Reagents
Standard Operating
Procedures
Good House Keeping
and Safety
Management Review
Maintenance, Calibration,
and
Validation of Equipments
Internal Quality
System Audits
Reference Materials
Quality System
Microbiological Cultures
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3. GMP GMP Concerned with Production הדרישות בייצור
Buildings and Facilities
Warehouse Facilities
Sampling & Dispensing
Manufacturing Areas
IPQC areas
Records and Reports
Process Controls
Cleaning
Process Validation
SOPs
Reworks
Ingredients controls
Training
Investigations
Lab Controls
Utilities
Stability Programs
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4. Investigational New Drug Application (IND) שלבים במחקר ופיתוח תרופה חדשה
Application to start clinical trials requires 3 main sections:
CMC (manufacturing information)
Preclinical and toxicology information
Clinical protocol and investigator information
Animal data must show drug is likely to be reasonably tolerated in humans
(Show file 2019)
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5. FDA Organization CBER - Center for Biologics Evaluation and Research
Office of Cellular, Tissue, and Gene Therapy
Office of Vaccines Research and Review
Office of Blood Research and Review
CDER - Center for Drug Evaluation and Research
CDRH - Center for Devices and Radiological Health
CFSAN – Center for Food Safety and Applied Nutrition
CVM – Center for Veterinary Medicine
NCTR – National Center for Toxicological research
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6. FDA = Food & Drug Administration
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7. Basic Disciplines of Drug Development המגמות בפיתוח תרופה
Chemistry, Manufacturing, and Controls (CMC)
(Pre) Nonclinical
Clinical
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8. Office of New Drug Chemistry (ONDC) חשיבות המחקר הכימי
To ascertain the: identity, strength, quality & purity of the new drug product
 includes evaluation of manufacturing process
 stability program
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9. What’s Important from a Chemistry Perspective?
Drug Substance (DS) can be quantitatively assayed in the Drug Product (DP).
(drug product = drug substance + excipients)
impurity profile of the DS:
be determined
be determined in the DP
be qualified by Pharm. / Tox. reviewer
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10. What’s Important from a Chemistry Perspective? (Cont’)
Stability of the DP be determined.
i.e., the physico-chemical properties of the DP have not changed over shelf-life period / clinical trial.
Analytical test procedures and acceptance criteria are indicative of product quality.
Batch-to-batch variations are minimized by compliance with cGMP.
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11. QUALITY SYSTEMS
Broad systems of regulations, standards, or policies that ensure the quality of the final product
GMP / GLP / GCP are examples of quality systems
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12. GMP is actually Good Common Sense
Quality Management
Quality Assurance
GMP
Production and Quality Control
E. Solomon M.Sc,
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13. QA, GMP & QC Inter-relationship
QC / GLP
E. Solomon M.Sc,
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14. WHAT IS PRODUCT QUALITY מהו איכות המוצר הביוטכנולוגי
What is a “good” product in Biotechnology
That depends… Consider biotech:
Research labs
Testing labs
Production facilities
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15. QUALITY PRODUCT: RESEARCH LAB.
Research lab, knowledge is product:
Knowledge of nature (basic research)
Understanding of technology (applied research, R&D)
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16. QUALITY SYSTEMS IN RESEARCH LAB
Quality system in research
Ensure meaningful data
has been around a long time
It is called: DOING GOOD SCIENCE
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17. “DOING GOOD SCIENCE” Less formalized than other quality systems
No laws to obey
But it exists
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18. INFORMAL SYSTEM
Consequences of poor quality product not life-threatening so
Government seldom involved in monitoring research quality
Oversight not generally by outside inspectors or auditors
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19. Oversight is by experts
THERE IS OVERSIGHT
Oversight is by experts
Grant review
Publications
Reputation
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20. Good Laboratory Practices
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.
GLPs are regulations published in the Code of Federal
Regulations (21CFR part 58)
The OECD Principles of Good Laboratory Practice
GLPs are not guidelines, they have the force of law.
GLP’s are not “watered down” GMPs!
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21. GLP - General Requirements
Appropriately qualified personnel
Adequate resources
Appropriate procedures for:
Sanitation, health precautions, clothing
Test protocol development, test methods
Data analysis, report development
Appropriately qualified study director
Quality assurance function
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22. Priority Essential Medicines
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23. 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
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