GLP
Statistical Procedures
Laboratory certification
Quality Assurance
Instrument Validation
Requirement for Document Records
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General Idea
Equipment records
by SAMM (Skim Akreditasi Makmal Malaysia)
Equipment & manufacturer name
Model or type
Serial number
based on ISO/IEC 17025
Certification of Facilities
Date equipment was received
Specimen & Sampling Tracking
Copy of manufacturers operating instruction
Certification of Analyst
Objectives
Not simply chosen from textbook
to provide a credible accreditation service to testing and calibration laboratories including medical testing laboratories
Acceptable proof of satisfactory training or competence .
Practitioners adopt certain standards which are acceptable.
Regulatory agencies describe acceptable statistical procedure.
Reagent / material certification
Criteria of evaluation
To assure reagents used are specified in the SOP
Adequate space
Storage
Documentation and Records
Ventilation
Hygiene
Necessary for any analytical laboratory
What was done
Data produced by faulty instruments may give appearance of valid data
How it was done
Quality Assurance Unit
When the work was performed
Who performed the work
Equipment need to be inspected, cleaned and maintained
Equipment for assessment of data need to be tested, calibrated and standardized
conduct of the technique, including the results of the observation or meas- urement, and demonstrating that the actions required by the protocol were carried out
The data should indicate that they were collected and recorded in accordance with the methods set out in the SOPs and Protocol
compliance with the schedule defined in the protocol. This is done by recording the date and, if necessary, the time that the procedure was conducted.
When instrument’s performance is outside the “control limits”, report must be discontinued
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Purchasing and testing
Handled by quality assurance programme
A group of people that ensure the proper GLP requirement is followed
REQUIREMENT
Responsibilities
Include the date opened
Stored : ambient temperature
Deteriorated/outdated reagent or solution - NOT USED
Expired date
Labeled
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Access to the updated study plans and SOP’s.
Documented verification of the compliance of study plan to the GIP principles.
. Inspections to determine compliance of the study with GLP principles.
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Three types of inspection.
Inspection of the final reports for accurate and full description.
Report the inspection results to the management.
Statements.
Accountability
person who was responsible for carrying out the procedure and recording the data.
Study-based inspections.
Qualification
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Facility-based inspections.
establish accountability for laboratory results.
Process-based inspections.
education
Training
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Experience
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- allows the possibility of identifying more quickly and easily the source(s) and error(s)
Can be done manually by hand with paper files or by computer with modern bar-coding technique
-taking corrective action to maintain acceptable quality of laboratory data.
Must be recorded to ensure all material are easily found and trace
vary from different laboratories
Specific laboratory procedure
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