In our most recent GMP Trends Report Issue #1176, simple labeling gaps revealed deeper weaknesses in procedural discipline and data defensibility.
In this highlighted 483, FDA noted a failure to follow procedures governing the control and usage of reagents, solvents, and solutions utilized in the Quality Control Laboratory.
The nuance in this observation is important: the firm did not follow its own requirements for how internal QC solutions must be labeled. The procedures were set, but they were not followed.
Per the firm’s procedure, all solutions in the QC laboratory were required to be labeled with specific identifying information, including: solution name, preparation date, notebook reference, preparer’s name, and use-before date.
During the walkthrough, FDA observed beakers of buffer solutions used for meter calibrations stored in the lab. Each beaker was covered and labeled, but the label only stated the strength of the solution. No other required identifying information was present, in conflict with the designed SOP.
A beaker labeled only with “strength” can feel harmless, especially in a working lab where analysts may believe everyone “knows” what the solution is and what it’s used for. But FDA’s attention here points to a broader compliance concept: In regulated systems, materials used to generate QC results are expected to be controlled, traceable, and verifiable, especially when they support calibration activities.
When investigators see that a firm has defined requirements, but lab practice routinely falls short, it can raise uncomfortable but necessary questions such as:
- Are procedures functioning as enforceable controls, or as theoretical documents?
- Is QC supervision detecting routine procedural drift?
- Are internal audits capturing basic lab control behaviors?
FDA specifically tied these unlabeled buffers to calibration activity. Because calibration sits upstream of routine testing, when investigators observe weaknesses around calibration inputs and the solutions used to establish instrument accuracy, it naturally pulls attention toward:
- how the lab ensures reliability of measurements
- whether records can support traceability of calibration activities
- the firm’s ability to defend results if questions arise later
This observation illuminates the intersection of laboratory practices, documentation discipline, equipment reliability, and data integrity expectations. FDA did not cite the absence of a written procedure. Rather, FDA cited failure to follow procedures.
Thank you for reading today’s GMP Trends Newsletter. We are grateful to have you as a reader. The 483 referenced in this newsletter is below:
….. The responsibilities and procedures applicable to the quality control unit are not fully followed.
Specifically, you failed to follow your procedures for the control, usage and storage of reagents, solvents and solutions used in your Quality Control Laboratory. Your procedures require all solutions in the Quality Control Laboratory to be labeled indicating specific information, such as the solution name, preparation date, notebook reference if required, preparer’s name, and use before date. During a walkthrough of the Quality Control Laboratory, … beakers of buffer solutions used to perform … calibrations of your… meters were observed stored in the laboratory covered with … Each beaker was only labeled with the strength of the solution. The labels on each beaker did not include any other identifying information as required by your procedures.
