Our Quality Mission

All manufacturers of finished products, packaging, and raw material ingredients are required by law to adhere to strict compliance testing requirements.  Yet, the FDA often finds deficiencies in laboratory testing procedures that cut corners or are otherwise lacking transparency – leading to potential violations of compliance law.  Such oversights can potentially cost customers millions in submission delays, approvals, product recalls or manufacturing interruptions.

NJ Labs got its start in 1936 by promoting quality in dairy & food production and over time as we’ve expanded to other industries, we’ve also been building a culture of quality ever since.  We are certified by the US Food & Drug Administration, the Drug Enforcement Administration, and New Jersey Controlled Substances and we are unique in our broad range of industry expertise.

We know how to work with the FDA but more importantly, how to conduct ethical analytical testing under strict CGMP requirements that comply with regulatory law.We invite you now to learn more about our Quality Assurance Program and how we promote Regulatory Compliance Transparency.   Our mission is to be recognized by our customers and regulatory bodies as the compass that points to quality.

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Our Quality Assurance Program

Since our beginning, NJ Labs (New Jersey Laboratories) has earned a reputation for quality and integrity by providing our clients with accurate and reliable chemical & microbiology testing services. NJ Labs has a Quality Assurance department responsible for maintaining a comprehensive and effective Quality Assurance Program, ensuring that data generated by our laboratories are scientifically valid, defensible, and within known acceptable parameters of accuracy. Quality at NJ Labs means full compliance with all requirements. Every aspect of our Quality Assurance Program is designed to ensure that client and regulatory requirements are met.The objectives of our Quality Assurance Program (QAP) are to:

  • Define both client and regulatory requirements

  • Train our staff to meet both sets of requirements.

  • Monitor our performance for adherence to requirements

Our QAP includes a quality assurance manager, quality assurance documentation, a strong training program, quality assessments, GMP audits, and a corrective action process. The Quality Assurance program is managed by the QA Manager who reports directly to the CEO.

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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 policies 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.

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Laboratory Instrumentation

 

The following is a comprehensive list of our laboratory instrumentation equipment.  NJ Labs also has a comprehensive instrument calibration, preventative and maintenance program to ensure that all instrumentation used are fully qualified for their intended use.

 

  •  Amino Acid Analyzer (post column derivitization)

  •  Karl Fischer Titration Apparatus (KFT Titrino)

  •  Auto Titrator (DMS titrino)

  •  Conductivity Meter

  •  Density Apparatus

  •  Disintegration Apparatus

  •  Dissolution Apparatus

  •  Evaporative Light Scattering Detector

  •  Flame Atomic Absorption Spectrophotometer

  •  Gas Chromatography (FID, TCD, ECD Detectors)

  •  High Performance Thin-Layer Chromatography (HPTLC)

  •  HPLC (High-Performance Liquid Chromatography) with VWD, DAD, RI, ELSD

  •  Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

  •  Infrared Spectrophotometer (FTIR)

  •  Lightnin Mixer capable of 20,000 RPM

  •  Melting Point Apparatus

  •  Microwave Digestion (Closed vessel) USP <232> and <233> compliant

  •  Muffle Furnace

  •  Nitrogen Analyzer (Dumas Method)

  •  pH Meter

  •  Polarimeter (digital)

  •  Refractometer

  •  Refrigerated Centrifuge (2°C to 40 °C)

  •  Rotary Evaporator

  •  Rotational (digital),Ubbelohde and Cannon-Fenske Viscometers

  •  Soxhlet Extraction

  •  Stability Chamber : CRT (25°C / 40 % RH)

  •  Stability Chamber: CRT (60°C / 75 % RH)

  •  Total Organic Carbon Apparatus (TOC) meets USP criteria

  •  UV/VIS Spectrometer

  •  Vacuum Ovens

  •  Zymark TurboVac

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