An outline on significance of quality system in maintenance of Good Laboratory Practices
1.0 Quality system
A documented quality assurance programme should be designed in compliance with good laboratory practices
Quality assurance programme should be designed and carried out by personnel who are directly responsible to management and are familiar with test procedures
The personnel in quality assurance programme shouldn’t be involved in conduct of the study
Quality system should be designed so that the measurements and calibrations comply with the specifications and the methods based on validation protocol are followed
Quality system in laboratory should be effective in assuring the processes or techniques or activities are in compliance with the planned arrangements
It should identify the non-conformities and correct them
Observations made during the internal and external audits should be evaluated and proper corrective actions should be taken
A documented quality policy should be present for an organization
1.1 Personnel
Responsibilities of the personnel in quality system
He should maintain copies of study plans & SOPs
He should have access to updated copy of master schedule
He should verify the information in study plan is in compliance with good laboratory practices and the verification should be documented
He should conduct inspections to check if all the studies are conducted according to good laboratory principles
Inspections done are of three types: they are study based inspections, facility based inspections and process based inspections
Records of the inspection conducted should be maintained
Final reports should be inspected so the methods, procedures, observations are accurate and completely described
If any inspections involves writing to management like study director, principal investigator and the management should be reported
Final report should be signed and it should include study phases and dates of inspection.
1.2 Internal quality system audits
Internal audits ensure integrity of analysis and they should be done periodically with a proper schedule and appropriate checklist
The operations should be in compliance with quality system and regulatory requirements.
Internal quality audits should be done by trained & qualified personnel
Schedule for the audit should be determined by the quality head of laboratory
When any diversion or non- conformities are observed then it should be reported to the quality manager and corrective actions should be initiated.
Quality manager should keep a record of analysis with its date and type of analysis and test system.
1.3 Management review
Top management conducts the quality system review and it should include the following
Internal audit report
Data from previous reviews
External audit reports
Surveillance report
Proficiency testing report
Feedback or complaints from laboratory services users
In house quality control checks details
Amendments made to quality system & Documentation
Training of new staff
Other requirements of laboratory
Quality assurance, good laboratory practices, quality system, internal quality system audits, management review
