We can prepare any kind of nucleotide in our GMP facility. We first develop, if necessary, the process in our R&D lab, then validate it in our GMP facility with our equipment and reagents. Nearly all TriLink products are diagnostic grade GMP and manufactured in compliance with ISO 9001 and FDA 21CFR 820.
Yes. We are ISO 9001 certified.
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.