ORA Laboratory Policies
Food and Drug Administration
5.8.1 Protection of Samples
The laboratory procedure in Volume II, Section 2, ORA-LAB.5.8 Sample Management, describes the receipt, processing, protection, storage, retention and disposal of samples. This procedure addresses the laboratory activities conducted to protect sample integrity.
5.8.2 Identification of Samples
The laboratory has a system for uniquely identifying samples. The sample number is used to track its progress from the time the sample is collected in the field until the analysis is completed and the sample is disposed. The sample number is also used to provide traceability between the sample and the data. The numbering system also provides traceability during transfer of samples within the laboratory and between ORA laboratories in the case of administratively transferred samples. The identification system is described in Volume II, Section 2, ORA-LAB.5.8 Sample Management.
5.8.3 Departures, Additions or Exclusions
Upon receipt of the sample, abnormalities or departures from normal or specified conditions, for example contract specifications, analysis requested, and chain of custody, are recorded according to the FACTS Manual and Volume II, Section 2, ORA-LAB.5.8 Sample Management.
When samples received do not meet established acceptance criteria inVolume II, ORA.LAB.5.8 Sample Management, laboratory personnel consult the customer for further instructions before proceeding. Communication with the customer is documented.
5.8.4 Protection of Samples During Processing and Storage
The procedure in Volume II, Section 2, ORA-LAB.5.8 Sample Management, provides the details for protecting test items from deterioration, loss or damage during storage and processing. The laboratory has arrangements for storage and security that protect the condition and integrity of samples. Sample security arrangements apply both in the laboratory and in the custodial areas.
220.127.116.11 Processing Instructions
Handling instructions provided with the sample are followed, as well as the instructions in Volume II, Section 2, ORA-LAB.5.8 Sample Management.
18.104.22.168 Monitoring of Environmental Conditions
samples are held under environmental conditions specified in the test method, those conditions are maintained, monitored and recorded. Monitoring records are collected according to established procedures. These activities are conducted according to the policies stated inVolume I, Section 5.3 Laboratory Environment.
- Volume II, Section 2, ORA-LAB.5.8 Sample Management.
- Each laboratory has a sample storage Work Instruction established in accordance with ORA system.