What do GMP, ISO and QSR mean, and how do they differ?

GMP stands for Good Manufacturing Practices, and refers to a system of manufacturing that guarantees reproducibility of product quality to set specifications. cGMP is simply Current Good Manufacturing Practices and refers to compliance with current regulations. It can be considered redundant since to be GMP compliant you must comply with current GMP regulations anyways. The requirements differ depending on what type of product is being manufactured and whether it is for pharmaceutical or diagnostic purposes. ISO stands for International Organization for Standardization, which offers a standard for operating a firm from management through manufacturing. It is more encompassing than GMP. QSR stands for Quality Systems Regulation, which are GMP standards described by the FDA for the manufacture of products for the diagnostic industry. The ISO and QSR systems each describe specific GMP standards. The ISO system pays more attention to the management of the firm and places a number of reporting loops in the firm to ensure attention to issues. The QSR system is more focused on the manufacturing systems, and the validation of those systems. Although neither standard is required to maintain GMP facilities, it is essential that a firm satisfies the requirements of the client’s quality system. Generally, this means conforming to ISO or QSR standards. Every product made at TriLink is manufactured under GMP. We are compliant with ISO 9001 and FDA 21CFR 820 regulations. We are in the process of developing a facility suited for the manufacture of pharmaceutical grade material for clinical trials.

2 thoughts on “What do GMP, ISO and QSR mean, and how do they differ?

  1. One does not need synthesising or manufacturing any new research chemicals in organic chemistry research laboratories, Do we?
    I think we have freedom of manufacturing any base or complex chemical in a test tube/round bottom flask.
    I know there is no regularisation in producing something ‘new & novel’ to help
    scientific community in the world

    • Dear Dr. Jadhav,

      You are right in the case of basic research. However, if and when you start down the path to commercialization you must start adhering to the relevant regulations. TriLink provides reagents for all stages of research and for commercialized products.

      Best regards,
      Elizabeth Hill

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