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 first believe.

Can I get research grade material that is well documented, but not as expensive as GMP grade material?

Yes! TriLink adheres to the FDA 21CFR 820 requirements, as we believe this is the best way to manage the firm. We find the costs of managing separate documentation systems (one for research grade material and one for GMP grade material) are more than the cost savings associated with the reduced documentation required for research grade materials. Therefore, at TriLink there’s no such thing as research grade material. All compounds are manufactured under a GMP system at comparable prices to research grade material from our competitors.

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.