The laboratory or Quality organization management should establish, implement and maintain a quality management system appropriate to the scope of its activities, including the type, range and volume of testing and/or calibration, validation and verification activities it undertakes.
The laboratory management should ensure that its policies, systems, programmes, procedures and instructions are described to the extent necessary to enable the laboratory to assure the quality of the test results that it generates.
The documentation used in this quality management system should be communicated, available to, and understood and implemented by, the appropriate personnel. The elements of this system should be documented, e.g. in a quality manual, for the organization as a whole and/or for a laboratory within the organization.
Note: Quality control laboratories of a manufacturer may have this information in other documents than a quality manual.
The quality manual should contain as a minimum:
- a quality policy statement, including at least the following:
- a statement of the laboratory management’s intentions with respect to the standard of service it will provide,
- a commitment to establishing, implementing and maintaining an effective quality management system,
- the laboratory management’s commitment to good professional practice and quality of testing, calibration, validation and verification,
- the laboratory management’s commitment to compliance with the content of these guidelines,
- a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the documentation concerning quality and
the implementation of the policies and procedures in their work;
- the structure of the laboratory (organizational chart);
- the operational and functional activities pertaining to quality, so that the extent and the limits of the responsibilities are clearly defined;
- outline of the structure of documentation used in the laboratory quality management system;
- the general internal quality management procedures;
- references to specific procedures for each test;
- information on the appropriate qualifications, experience and competencies that personnel are required to possess;
- information on initial and in-service training of staff;
- a policy for internal and external audit;
- a policy for implementing and verifying corrective and preventive actions;
- a policy for dealing with complaints;
- a policy for performing management reviews of the quality management system;
- a policy for selecting, establishing and approving analytical procedures;
- a policy for handling of OOS results;
- a policy for the employment of appropriate reference substances and reference materials;
- a policy for participation in appropriate proficiency testing schemes and collaborative trials and the evaluation of the performance (applicable to national pharmaceutical quality control laboratories, but may be applied by other laboratories); and
- a policy to select service providers and suppliers.
The laboratory should establish, implement and maintain authorized written SOPs including, but not limited to, administrative and technical operations, such as:
- personnel matters, including qualifications, training, clothing and hygiene;
- the change control;
- internal audit;
- dealing with complaints;
- implementation and verification of corrective and preventive actions;
- the purchase and receipt of consignments of materials (e.g. samples, reagents);
- the procurement, preparation and control of reference substances and reference materials (8);
- the internal labeling, quarantine and storage of materials;
- the qualification of equipment (11);
- the calibration of equipment;
- preventive maintenance and verification of instruments and equipment; (l) sampling, if performed by the laboratory, and visual inspection;
- the testing of samples with descriptions of the methods and equipment used;
- atypical and OOS results;
- validation of analytical procedures;
- cleaning of laboratory facilities, including bench tops, equipment, work stations, clean rooms (aseptic suites) and glassware;
- monitoring of environmental conditions, e.g. temperature and humidity;
- monitoring storage conditions;
- disposal of reagents and solvent samples; and(t) safety measures.
- The activities of the laboratory should be systematically and periodically audited (internally and, where appropriate, by external audits or inspections) to verify compliance with the requirements of the quality management system and to apply corrective and preventive actions, if necessary.
- The audits should be carried out by trained and qualified personnel, who are independent of the activity to be audited. The quality manager is responsible for planning and organizing internal audits addressing all elements of the quality management system. Such audits should be recorded, together with details of any corrective and preventive action taken.
- Management review of quality issues should be regularly undertaken (at least annually), including:
- reports on internal and external audits or inspections and any follow-up required to correct any deficiencies;
- the outcome of investigations carried out as a result of complaints received, doubtful (atypical) or aberrant results reported in collaborative trials and/or proficiency tests; and corrective actions applied and preventive actions introduced as a result of these investigations.