GLP PPT.ppt
- 2. SCOPE Scope of this Presentation is to cover Good Laboratory Practice (GLP) required for Pharmaceutical Products also known as “Drug Product”
- 3. DEFINATION & IMPORTANCE The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system concerned with the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, reported and archived The GLP plays an important to ensure safety, quality and uniformity of Pharmaceutical products.
- 4. MAIN FEATURES OF GLP Laboratory Safety Accuracy Reliability Reproducibility Documentation Training Review/Check
- 5. OBJECTIVES OF GLP GLP makes sure that the data submitted are a true reflection of the results that are obtained during the study. GLP also makes sure that data is traceable. Promotes international acceptance of tests.
- 6. MISSION OF GLP Test systems Archiving of records and materials. Apparatus, material and reagent facilities. Quality assurance programs. Performance of the study. Reporting of study results. Standard operating procedures (SOP) Personnel and test facility organization
- 7. STANDARD OPERATING PROCEDURES (SOP) Written procedures for a laboratories program. They define how to carry out protocol-specified activities. Most often written in a chronological listing of action steps. They are written to explain how the procedures are suppose to work
- 8. INSTRUMENTATION VALIDATION This is a process necessary for any analytical laboratory. Data produced by “faulty” instruments may give the appearance of valid data. The frequency for calibration, re-validation and testing depends on the instrument and extent of its use in the laboratory. Whenever an instrument’s performance is outside the “control limits” reports must be discontinued
- 9. REAGENTS AND SOLUTIONS Requirements: Reagents and solutions shall be labeled Deteriorated or outdated reagents and solutions shall not be used Include Date opened Stored under ambient temperature Expiration date
- 10. LABORATORY SAFETY It is very important to be safe when working in a laboratory. Wear Personal Protective Equipment (PPE) such as Goggles & Gloves Avoid exposure to Hazardous Material by planning all procedures before starting any laboratory work.
- 11. BEFORE LAB WORK, GET TO KNOW: Hazards of materials & agents and their prescribed safety procedures
- 12. ALSO GET TO KNOW: Emergency spill procedures, use of adsorbents and disinfectants Designated escape route and alternate Location of fire ext., eye wash, shower, first aid, and spill kits
- 13. WHILE WORKING IN THE LAB: Shoes with full coverage and good grip soles Restrain long hair, loose clothing and jewelry Use appropriate eye, skin, and hand protection
- 14. EYE PROTECTION Protects against risk of flying objects or dust particles, splashes of hazardous materials or harmful rays
- 15. GOGGLES Work with significant risk of splash of chemicals or projectiles Can be worn over prescription glasses
- 16. HAND PROTECTION Protects against risk of cuts, abrasions, burns, or exposure to hazardous materials. Requires selection of the appropriate chemical resistant gloves
- 17. WHILE WORKING IN THE LAB: Handle volatiles in a chemical fume hood Contain bioaerosols in a biological safety cabinet
- 18. WHILE WORKING IN THE LAB: Authorized persons only Identify EVERYTHING! No food, beverages, tobacco products, or application of cosmetics
- 19. BEFORE LEAVING THE LAB: Turn off: Gas Water Power supplies Vacuum lines Compression lines Heating apparatus
- 20. TRAINING Requirements for training of Lab. Colleagues: Certification of Analysts Job competency standards Job descriptions Continuing education programs and annual refreshers are fundamental for GLP Compliance.
- 21. WHAT ARE THOSE GOOD LABORATORY PRACTICES? CHEMICAL LABORATORY: All analytical data generated by an Analysts must be counter check by second analyst with full signature and date. All the documents must carry the name of the products and batch# and date. Use of Blanco or other similar correction fluid must be prohibited in the Lab. Correction can be done by simple cross once and sign. Testing must be done as per approved Method or SOP. No manual correction should be done on already approved method or SOP. If any such method need correction, then proper procedure of such revision must be in place. All raw data must be available for review and check. All the instrument must be calibrated as per procedure and frequency defined. Handling and storage of Reference Standard both Primary and Secondary.
- 22. CONCLUSION: The result of GLP is that the performance of a laboratory is improved and its working effectively controlled. This results in an improved reputation for the laboratory (and for the institute as a whole). In short, the message is: - say what you do - do what you say - do it better - be able to show what you have done
- 23. Thank You