In any analytical laboratory that performs cGMP testing, data review is required. However, to an analytical chemist that prefers benchwork, reviewing the data of a fellow analyst is often deemed an undesirable chore. The data reviewer rarely gets a “Thank you” for pointing out irregularities in documentation. The role of the data reviewer is to ensure that the laboratory analyst’s work adheres to written test methods and established SOPs and that the conclusions are scientifically correct. This is a heavy responsibility that is crucial in protecting a company from significant errors or fraudulent practices in the laboratory.
The review of laboratory data is required by 21 CFR § 211.194(A)(8): “The initials or signature of a second person showing the original records have been reviewed for accuracy, completeness, and compliance with established standards.” This statement does not indicate how data is to be reviewed or the skill set that is required to be capable of reviewing data properly. Common sense dictates that a data reviewer should be a person with the knowledge and experience to fully understand the data that they are reviewing. This “common sense” is supported by 21 CFR § 211.25(a): “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.” When GMP regulations were initially written in the 1970s, the vast majority of laboratory raw data was recorded on paper and it was the paper that represented the evidence of the work performed in laboratory. Data review was then performed by a peer or supervisor.
With the evolution of computerized data acquisition systems and electronic laboratory notebooks over the past few decades, in conjunction with the focus on data integrity, the skill set of data reviewers has had to evolve and become more specialized. For example, data reviewers must have a firm grasp on how to review time/date stamps and audit trails in electronic laboratory notebooks in order to ensure that laboratory documentation was performed in real time. Additionally, data reviewers must be adept in auditing computerized laboratory instrument systems to ensure there is no “extra data” within the system. As the tools to test samples has become more sophisticated, so has the skill set of the effective data reviewer.
Today’s laboratory data reviewer must have the keen instincts of a detective and should not be willing to accept data at face value since, in any instance, there may be trouble looming below the surface of what appears to be acceptable laboratory data. The job of a data reviewer may be viewed as “Thankless” by those assigned the task and considered to be an afterthought by others. However, data reviewers serve a vital role as the safety net of both the analytical laboratory chemists and the company that employs them. To those who review analytical data in a GMP laboratory, I want to extend a big THANK YOU for doing this “Thankless” job.
