ORA Laboratory Policies
Food and Drug Administration
5.5.1 Laboratory Equipment
The laboratory has sample preparation, measurement and test equipment for the correct performance of the tests and calibrations. The laboratory also has ancillary equipment for processing samples and for processing data.
The laboratory or other ORA component, i.e., Office of Regulatory Science, purchases the equipment used by the laboratory. Maintenance contracts are established as needed. In those cases where the laboratory leases equipment it has direct control concerning its use. Leased equipment is managed in the same manner as purchased equipment according to the management system requirements.
ORA laboratories maintain an equipment inventory of all laboratory equipment used to perform regulatory testing.
5.5.2 Equipment Capability
Equipment and its software used for testing are to achieve the accuracy expected and comply with specifications of the testing concerned. Laboratory equipment that has a significant effect on the results has a calibration schedule. The equipment performance is verified and verification records are maintained. Equipment is to meet the laboratory's testing parameters and conform to standard specifications before being placed into service.
5.5.3 Authorized Operation
Personnel are authorized to operate equipment according to Volume I, subsection 5.2.5 Management Authorization. Authorization is based on work assignment, training, experience and demonstrated proficiency. Equipment manuals and maintenance procedures are maintained and supplied to laboratory personnel as described in Volume I, subsection 4.3.1 GeneralandVolume II, Section 2, ORA-LAB.5.5.1 Instrument and Equipment Documentation and Records.
5.5.4 Equipment Identification
Each item of equipment used for testing has an FDA property number or an identification number that is unique to each instrument.
5.5.5 Equipment Records
Records are maintained of each item of equipment and its software significant to the tests or calibrations performed according to the procedure in Volume II, Section 2, ORA-LAB.5.5.1 Instrument and Equipment Documentation and Records.
The records include at least the following items:
- identity of the item of equipment and its software;
- manufacturer’s name, type identification, and serial number or other unique identification;
- performance checks that equipment conforms to testing parameters and acceptance criteria;
- location of the equipment;
- manufacturer’s instructions;
- dates, results and copies of reports and certificates of calibrations, adjustments, acceptance criteria, and the due date of next calibration;
- maintenance plan and maintenance carried out to date; and
- any damage, malfunction, modification or repair to the equipment.
5.5.6 Management of Equipment
The laboratory has a procedure in Volume II, Section 2, ORA-LAB.5.5 Equipment for the safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and to prevent contamination or deterioration.
126.96.36.199 Out of Service
Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, is taken out of service. It is isolated to prevent its use or clearly labeled or marked as being “Out of Service” to prevent its use until it has been repaired and shown by calibration or test to perform correctly.
188.8.131.52 Retesting and Calibration
Laboratory personnel examine the effect of quality control analyses that indicate the defect or departure from specified limits on previous tests according to Volume I, Section 4.9 Control of Non-conforming Work.
5.5.8 Calibration Status
Equipment under the control of the laboratory and requiring calibration is labeled or coded to indicate the calibration status, including the date when last calibrated and the date due for recalibration. Alternatively, equipment calibration status may be identified in an associated record to indicate the status of calibration.
5.5.9 Equipment Leaving the Laboratory
If for any reason equipment leaves the direct control of the laboratory, the function and calibration status of the equipment is checked upon return and shown to be satisfactory before the equipment is returned to service.
5.5.10 Calibration Confirmation
Intermediate calibration confirmation checks are performed to maintain confidence in the calibration status of the equipment. These checks are conducted according to the procedure in Volume I, Section 5.9 Assuring the Quality of Test Results.
5.5.11 Correction Factors
Where calibrations give rise to a set of correction factors, these factors are communicated to users.
Test and calibration equipment, including both hardware and software, are safeguarded from adjustments that would invalidate the test or calibration results. Safeguards are provided using access control to the laboratory.
- Volume II, Section 2, ORA-LAB.5.5 Equipment
- Volume II, Section 2, ORA-LAB.5.5.1 Instrument and Equipment Documentation and Records
- Each ORA laboratory has established equipment maintenance schedules in accordance with the ORA system.