Regulatory Compliance Transparency

NJ Labs has been registered and inspected by the FDA since 1978.   We have well-established quality systems and transparent processes in place that demonstrate daily regulatory compliance with the FDA. We follow Title 21 of the Code of Federal Regulations: Food and Drugs (21 CFR). All analyses performed in our laboratory meet strict compliance as described in the Current Good Manufacturing Practices (CGMP).

The FDA’s policies and procedures are published as Good Guidance Practices (GGP’s) to guide companies in developing and issuing polices that are to be practiced as prescribed by the agency. The guidance documents are designed to ensure data integrity in current good manufacturing practice, as required in 21 CFR. All data is expected to be reliable, accurate, traceable, true and complete.  All testing facilities must have written standard operating procedures in place to define the methods, systems and procedures employed in the laboratory. Written procedures are critical to ensure the quality and integrity of the data obtained.

Our Quality Assurance Department inspects the “Data Lifecyle” generated by our laboratory to ensure that these analyses comply with all applicable regulations as described above.  Data Lifecycle refers to how data is generated, processed, reported, checked, used for decision-making, stored and finally discarded at the end of the retention period. NJ Labs also has a comprehensive instrument calibration, preventive and maintenance program to ensure that all instrumentation used are fully qualified for their intended use.