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. 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 also offer QSR, including dedicated manufacturing suites, and are compliant with ISO 9001:2008 and FDA 21CFR 820 regulation for ASR manufacturing.

Is TriLink ISO or FDA certified?
No, we are not currently certified. At TriLink, our focus is on exceeding our customer’s standards of quality, which are often greater than industry standards. We are currently in the process of becoming ISO certified, however we have been ISO compliant for years. We are not FDA certified because our products are sold for diagnostic and research purposes only. If you have any concerns, please contact us to discuss your quality requirements. We are willing to meet any quality standards a specific job requires.

What levels of GMP manufacturing do you offer?
We offer several levels of GMP manufacturing, tailored to meet your needs and budget. In most cases our standard GMP product is sufficient because all of our raw materials are certified before use and all of our products come with a certificate of analysis. However, we also offer higher levels of assurance. The next level includes more sophisticated validation of instruments, which are maintained separately from the main synthesis facility. The highest level is our QSR lab, which offers a clean room environment with instruments and rooms devoted to a single product at a time.

Which level of GMP do I need?
This is a decision for your regulatory department, however we can offer advice based on your specific circumstances if you are unsure. Often, you do not need as stringent a manufacturing system as you may at first believe.

Do you offer pharmaceutical grade products?
No, we do not. We offer materials suitable for research through pre-clinical trials. Our products are adequate for all work up to the actual injection of humans. If you require an oligonucleotide for clinical trials we recommend our alliance partner Avecia Oligomedicines.

What kind of nucleotides can you prepare under GMP conditions?
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. All TriLink products are GMP and manufactured in compliance with ISO 9001:2008.