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Deteriorated/outdated reagent or solution - NOT USED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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