Good Laboratory Practices and Requirement of premises and Equipment's
- General Requirements:-
a) The laboratory or the the organization of which it is a part must be an entity that is legally authorized to function and can be held legally responsible.
b) Management ensures that the laboratory carry out its testing, calibration, validation, and all other technical activities in such a way as to meet Good Laboratory Practices (GLP) requirements.
c) The Quality manger shall prepare a schedule for technical audit of the laboratory for GLP compliance by an expert or experts appointed by the top-management other than the in-charge of the laboratory and shall ensures the maintenance of documented quality systems as per quality manual.
- Premises:-
a) The laboratory shall be designed, constructed and maintained so as to prevent entry of insects and rodents besides cross contamination.
b) Wall, floor and ceilings ( interior surface) shall be smooth and free from cracks and permits easy cleaning and disinfection.
c) Provision is made for space and equipment's to carry out necessary tests but also for utilities like power, water and gases.
d) The lab shall be provided with adequate lighting and ventilation to maintain satisfactory temperature and relative humidity that will not adversely affect the testing and storage of drugs or the accuracy of the functioning of the laboratory equipments or instruments.
e) The drainage system facilities shall be such as to facilitate proper maintenance and prevent water logging in the laboratory.
f) The tabletops are constructed by acid, alkali and solvent resistant material and smooths and free from crevices as possible.
g) All biomedical laboratory waste shall be destroyed as per the provision of the Bio-medical waste.
h) Adequate space and proper storage condition shall be provided for keeping Reference and working standards. SOP for the maintenance of reference standards and evaluation of working and secondary standards shall be prepared by the laboratory.
i) Air circulation is maintained in the area where sterility test is carried out.
- Personal:-
a) Staff in the laboratory shall possess necessary qualification, training and shall have adequate, experience for assigned duties.
b) A training record of all the personnel shall be maintained.
c) Head of laboratory must be high professional standing with experience in drug analysis and laboratory management.
- Equipment's
a) The laboratory shall be furnished with all type of equipments as may be necessary for carrying out the different activities with the laboratory.
b) The analytical instruments shall be housed in dust-free environment and whenever required, condition of temperature and humidity be made and recorded.
c) The instrument's, instrument bench and surrounding area shall be kept cleaned and tidy at all times.
d) Instruments required calibration shall be calibrated at regular intervals and records of such calibration or maintenance be maintained and there shall be written instruction in the for of SOPs for the operation, maintenance and calibration of instruments.
e) Equipment record shall maintained and such records shall contain the following information
I) name of equipment or machine or apparatus.
II) Manufactures name, model number and type of identification
III) serial number
IV) date on which equipment was received in lab.
V) current location.
VI) condition when received (e.g. new, used, re-conditioned)
VII) copy of manufacturing operation instructions
VIII) frequency of calibration
IX) frequency of maintenance
X) log book (day to day entry including status of the equipment)
XI) responsible staff for monitoring the calibration and maintenance status
XII) calibration records
XIII) list of authorized users or operators, if any
XIV) history of any damages, malfunction, modification or upgradation, repair and calibration.
XV) list of spares and accessories, if any
f) A progress register for non-functional equipment and action for procurement of spares and accessories, monitoring thereof, shall be maintained.
g) A standard operating procedure for preventive maintenance of machine or equipment or apparatus shall be prepared by the laboratory.
h) other equipment such as burettes, pipettes, volumetric flasks, weight boxes, thermometers etc. shall be thoroughly checked for accuracy of calibration before acceptance for use.
i) Maintenance procedure in the form of standard operating procedure must be prepared and regular servicing must be performed by the maintenance engineer or specialist.
j) Equipment instruments giving anomalous results or defective must be labeled as "out of order" till they are repaired and after instruments is repaired it should be calibrated before use.
k) The maintenance of equipment for services like electricity, gas, water, steam, and compressed gas shall be handled by competent person.
l) Autoclaves must meet the requirement described for operation, safety and validation procedure and the validation carried out by the laboratory shall be recorded.
m) Fume cupboard; work involving the evolution of harmful and obnoxious vapours shall be carried out in a fume cupboard. The exhaust system of the fume cupboard shall be checked frequently to ensure that it is in order. There should be water drainage system inside the fume cupboard and shall be checked frequently to ensure that there is no water logging and it is in order.
- Chemical and Reagents:-
a) The storage and handling of chemicals and reagents shall be done in a manner considering the physicochemical properties of these substance and the hazards involved in their use.
b) All reagents and solutions in the laboratory shall be properly identified with a label.
c) A standardization register shall be maintained by the laboratory along with the raw data and standard operating procedure for preparation and standardization on stock solution, standard solutions, volumetric solution must be prepared for the guidance of staff.
d) containers of stock solutions and of standards solutions shall bear the following details;
i) name of analytical chemist who prepared the solution.
ii) date of preparation
iii) each volumetric solution shall have "use before date" depending upon the stability of the solution and
iv) standardization records.
e) The transfer of hazardous chemicals and regents from one container to another container shall be carried out with suitable equipment by taking the care of safety and no make-shift or hazardous methods must be resorted to.
- Good House keeping and safety:-
a) General and specific written down instruction for safety shall be circulated to each staff member and the instruction be revised periodically as appropriate.
b) Safety data sheet must be available to staff before testing is carried out
c) drinking, eating and smoking shall not be permitted in the laboratories, food for human consumption shall not be kept in working or storage area.
d) food meant for test animal shall be handle by the workers under the guidance of a veterinary doctor or qualified person. In the animal house the facilities for collection and disposal of animal waste or safe sanitary storage of waste before removal from testing be provided.
e) staff must wear laboratory coats or other protective clothing including gloves and face mask and eye protection wherever required.
f) laboratory must have adequate first aid kit and fire fighting equipments located at right places. staff must familiar and trained for the usages of fire fighting equipment including fire extinguishers, fir blankets and gas masks.
g) Chemist carrying out sterility tests shall wear sterilised garments including headgear, face masks and shoes;
h) Water showers shall be installed at appropriate placed in the laboratory
i) Rubber suction bulb must be used on manual pipettes and siphons.
j) Appropriate facilities for the collection, storage, and disposal of wastes shall be made available.
- Maintenance, Calibration and validation of equipments:-
a) All equipment and other devices used in the laboratory shall be use appropriate methods and procedures for all tests and calibration and they shall be regularly calibrated and validated. The frequency of calibration may differ from instrument to instrument.
b) The original equipment manufacturers recommendation along with the experience of the laboratory staff and the use of equipment per day may also be considered while fixing the frequency of calibration.
c) Most of the equipment and instruments, standard operating procedure for calibration and calibration schedule be prepared by the laboratory and a logbook shall also be prepared by each laboratory for proper documentation of calibration results.
- Reference material:-
a) Reference material are necessary for the testing and/or calibration, validation or verification of a sample of equipment, instrument or other devices and all such materials shall be traceable to agency authorised by Govt. bodies.
b) The laboratory shall prepare working standard by comparing with the reference standards and shall be routinely checked for their purity by selecting parameters such as identity, loss on drying or on water, impurity and assay etc.
c) Whenever, any new reference materials is received by the laboratory a code number shall be assigned an this code number shall be quoted on the laboratory note book and analytical work sheet.
d) A register pertaining to reference and working material must be maintained by the lab.
* source of supply
* code number of reference material.
* date of receipt
* batch number or identification number of the supplying agency
* details like assay, water content or any other information provided
* storage condition of the material
* data of expiry, if any and date of manufacturing if possible
e) All working standards shall be checked at appropriate intervals or before use to ensure that it has not deteriorated or decomposed during storage. These observation be recorded in a register. All reference and working standards shall be stored at appropriate storage condition.
- Microbiological cultures:-
a) A SOP for maintenance of microbial culture and sub-culture must be prepared by the laboratories.
b) If the cultures have become non-viable or mutant, proper procedure shall be followed to destroy these cultures by autoclaving under an authorized personnel for biological testing.
c) All activities be carried out in a aseptic area by authorized person
- Quality system:-
a) The measurement and calibration shall fully conform to the compendial requirement and the methods demonstrably based on the validation protocols are followed.
b) It shall be effective in providing necessary assurance that the activities or process or techniques or practices comply with planned arrangements.
c) Remedial action on the observation by internal and external audit are taken appropriately and
e) It shall have a documented quality policy for the organization.
- Internal quality system audit:-
a) Internal audits are done to assure the integrity of the analysis and such audits shall be conducted periodically with a predetermined schedule and procedure with appropriate checklist, to verify that the operation continue to comply with the requirement of quality system.
b) The periodicity of quality audit shall be fixed by head of the lab. so that each activity is audited at least once in a year.
c) Head of the laboratory will be responsible for initiation of the corrective action arising from audit and verification or corrective action.
d) The quality manager shall maintain all the records of the analysis being conducted which includes test system, the type of analysis, date on which analysis is done etc.
- Management Review:-
a) Quality system review shall be conducted by the top management atleast once in every twelve months.
Superb
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