In this slide ,explain about GLP I.e Good Laboratories Practices to safe environments ,human and animal health. Which is apply to all laboratories, Pharmaceutical and Cosmetic Industries, Universities etc.Described about different points like 5S,Cleaning,Documentation,Calibration Handling, Training,Induction Precautions,Safety,Hygiene , Test system, Standard Operating Procedure I.e “SOP”etc. According to OECD and WHO guidelines must be followed GLP . Also describe about D&C act and rules 1945. GLP is explain in schedule T of D&C act for Ayurvedic, Siddha and Unani Medicine.

1. GLP
GOOD LABORATORY
PRACTICES
Presented By
Medha Tiwari
M.Pharma ’Ayurveda’ 1st year

2. Definition
• A quality system concern with the organisational process and the
condition under which non- clinical health and environmental safety
situations are planned, performed, monitored, recorded, archived,
reported.
• GLP requirements of premises and equipments are mentioned in
schedule L-1 of Drug and Cosmetic Act (D&C act).

3. History
• GLP is an FDA regulation
• It is formal regulation that was created by the FDA( United States
food and drug administration) in 1978.
• FDA become aware of cases of poor laboratory practices all over the
world and concern about the validity of pre- clinical safety data
submitted to FDA in contest of new drug development ( NDA).
• It yield indications of insufficient planning, documentation, methods,
results that cause animal harm.

4. Quality
assurance
Principal
GLP
Principal
Test facility
and
personnel
Storage and
retention of
records and
materials
Reporting
of study
result
Performance
of study
Facilities
Test
System
Apparatus,
Materials,
Reagents
Test and
Reference
substance
SOP

5. •GLP principal generally apply to :-
MANUFACTURING
LABORATORIES
GOVERNMENT
LABORATORIES
UNIVERSITY

6. 5S
1. Sort
2. Set in order
3. Shine
4. Standarize
5. Sustain

7. Important in GLP
1. General requirements
2. Personnel
3. Facilities
4. Equipment
5. Chemicals and Reagents
6. Storage
7. Safety and Precautions
8. Records and Reports

8. General requirements
Legally authorized.
Carry out testing, calibration,
validation to meet GLP requirements.
Qualified individual as quality
manager
Regular audit for GLP compliance.

9. Personnel
• Each individual in supervision of
non-clinical laboratory study shall
have :-
1. Necessary qualification
2. General and Specific training
3. Adequate experience
4. Health precautions

10. Facilities
• Suitable size, location, construction and design to prevent entry of
insect and rodents.
• Lighting and air ventilation
Example:- HEPA filter, HVAC(heating ventilation air conditioning)
• Drainage system
• Bio medical waste management
• Cleaning and fumigation
Example:- 0.1% teepol and silvicide

11. Equipment
• Lab have adequate space and furnished to carry
out different activities in lab.
• Do calibration and verification at regular interval
of instrument.
• Equipment records contain:-
• Name of Equipment, Manufacturer, Model,
Identification no.
• Date of receiving and condition
• Frequency of calibration and maintenance.
• Log book
• List of authorised users
• List of spares and accessories
• SOP for maintenance
• If defected labelled as “Out-of-Order” till
repaired
• Fume cupboard

12. Chemical and Reagent
• Reagent and Solutions should be labelled
• Volumetric sol. Should be standardised
according to SOP along with raw data
• Container of stock sol. , standard sol.
contain :-
• Name of analytical chemist
• Date of preparation
• Use before date
• Standardisation record
• Reagent and solution store in ambient
temperature

13. Storage
• Storage conditions are maintained and container shall be labelled by
name, batch number
• All the documents, BMR shall be store in document controlled room
in specific pattern
• Paper documents shall not be kept for long periods under high
humidity
• Original documents are stored ensure their security and confidentiality
• Residual sample shall be retained in proper storage condition for
period of one year after final report

14. Safety and Precautions
• General and specific written instructions for
safety
• Poster, Seminar, Display
• SOP for safety, house keeping acc. to rule and
regulation of gov. of India :-
• Safety data sheet
• Eating, drinking rule.
• Wear lab coat, gloves, face mask, eye protection
• First aid kit and fire fighting equipment, Antidote
• Colour identification code
• Collection, Storage and disposal of waste

15. Record and reports
• It have starting and completion dates
• Objective and procedure stated in protocol (change in protocol)
• Description of materials and test methods
• QA program statement
• Storage of specimen, reference items, raw data and final report
• Master copy of records shall be maintained by QAU
• If any change in SOP than must be have change controlled documents

16. Thank you