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1. Data Integrity ("DI")
The DI guarantees that the data generated during analytical tests have not suffered any alteration, loss or destruction, either accidentally or intentionally. This is to ensure the quality and reliability of the results, as this is a priority for regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These agencies have published guidelines on data integrity and compliance with Good Manufacturing Practices that are easily accessible to any laboratory analyst or technician.
In parallel, DI is closely related to the ALCOA+ concept, which is why it has become quite common in recent years within the pharmaceutical industry. It should be noted that despite all the efforts that have been made to implement data integrity, violations and observations are still frequently found in pharmaceutical companies. Even though these faults may be due to the use of non-validated computerized systems when talking about systems with electronic records, many of them may also be due to the lack of education and awareness regarding the DI identified by the analysts during the generation of results.
2. Use of personal protective equipment and following safety protocols
All personnel involved in laboratory operations should keep in mind that, within the laboratory and regardless of the field to which it is directed, chemical, physical and biological hazards can be detected. Therefore, it is necessary to use relevant safety equipment to prevent diseases and accidents that can alter the health of workers. Although the risk is difficult to eliminate, protective equipment and the establishment of adequate safety protocols can reduce it, but this requires the participation and attitude of responsibility of all laboratory personnel, which today is identified as a company culture.
3. Following Standard Operating Procedures
All tests and procedures performed in a laboratory must be documented through the Standard Operating Procedures (SOPs). It is basic for the work as a laboratory technician or analyst to carry out the procedures as found in the SOPs, as these have already gone through a validation process, which ensures the ability to reproduce the results consistently when the steps are followed to the letter.
In conclusion
For the reasons previously described, it is a priority that laboratory personnel receive training prior to the performance of their activities and are kept up to date. This will allow these practices to be adopted as a culture and better-quality products will be manufactured.
