Regulatory Compliance

New Jersey Laboratories has been registered and inspected by the FDA since 1978. The Food and Drug Administration (FDA) is an agency that is responsible for “protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”

We have well-established quality systems to reflect daily regulatory compliance. 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 Unit inspects the “Data Lifecyle” generated by the laboratory to ensure that these analyses comply with all applicable regulations. 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. New Jersey Laboratories also has a comprehensive instrument calibration, preventive and maintenance program to ensure that all instrumentation used are fully qualified for their intended use.