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.
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
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
