GUIDLINES FOR GOOD LABORATORY PRACTICES [GLP]

headings covered under this topic are:-
INTRODUCTION
OBJECTIVES
PRINCIPLES
FUNDAMENTS
REGULATIONS
BENEFITS
DO'S
REFERENCES

1. GOOD LABORATORY PRACTICES Presented By:- Sakshi Srivastava M. Pharm 1 st year (Pharmacology) [GLP]

2. INTRODUCTION [1] GLP is an FDA regulations. GLP is a set of rules, operating procedures and practices established by an organization to ensure the quality and accurate results in a laboratory practice GLP i.e. Good Laboratory Practices was introduced for the non-clinical safety studies in 1976 . It has been introduced due to the poor and dishonest practice in laboratory. 1

3. OBJECTIVES OF GLP 2

4. PRINCIPLES OF GLP PRINCIPLES OF GLP Safe operating procedures SOPs Recording system Trained personnel Validated equipment Validated reagents Predetermined study design Correctness of result 3

5. FUNDAMENTS OF GLP [2] 4

6. REGULATIONS OF GLP [3] 5 The area or premises should be free from smoke, smell, dust, etc. It should have good ventilation and proper illumination. It should Prefer natural light. It should have air conditioned lab with humidity control. It should have enough space for measuring and testing instrument. There should be proper arrangement of testing. It should have clean floors, walls as well as ceiling. There should be proper storage areas.

7. 7 BENEFITS OF GLP Provide guidelines for performing testing and measurements in details. It will give better image of the company. Provides tips for analysis of data and prevent uncertainty. Provide guidelines for maintenance of instruments. Preservation of test records.

8. 8 DO’S FOR GLP Prepare location list and display it. DO’S FOR GLP Put ladders for things stored on top. Follow “FIFO”. Store heavy things at bottom. Give name of location to everything. Keep things at it’s location after use.

9. REFERENCES Dr. Kumar K.P. Sampath, Dr. Bhowmik Debjit, Bhanot Rishab, Goswami Shambaditya; “A text book of industrial pharmacy-II”, published by Nirali Prakashan, 1 st edition (June 2020), page no. 4.24-4.27. “Good Laboratory Practice (GLP) Training Manual”, Dr. kioy Deborah, Pre-clinical Coordinator, TDR/WHO; ISBN 978 92 4 154757 4. Akyar , Isin . "GLP: Good laboratory practice." Modern Approaches To Quality Control (2011): 37-56. 6