Most, if not all, customers in this industry want to see continual improvements in the quality systems governing the critical raw materials that they use, and improvements in the integrity of the supply chain. It makes sense from a quality and safety perspective for the products that they are producing - and the patients who receive those products. Further, it is a clear objective of the regulatory bodies, e.g. FDA, to focus on these type of improvements and to push these down the supply chain.
We hear about these desires from our customers every day. As prudent business people, we want to deliver as much as we can against those demands - it just makes sense. However, given our portfolio of literally 100,000 plus products - it is simply not possible for us to offer all of those items under GMP. Nor would there be a market for every item even if we could and did. Many would be prohibitably expensive if we could figure out a way to drive to cGMP status.
Given the complexitiy of our product mix (the numbers & arrays of chemistries represented), the fact that the majority were and are intended for research use, and the practical limitations of being able to manufacture "anything under the sun" under GMP, we have to take a different approach. This approach requires us to be realistic about what we can control in the supply chain and in our own manufacturing environments. It also requires us to be practical on what we can do economically to be competitive in the market. It requires us to pick items that will be profitable to us and where we can offer true value to the customers purchasing these products. And, we need to be able to stand behind the quality claims that we make for any given product.
This led us to create the Enhanced Quality Profile (EQP). EQP contains Standard, Premium, Elite, cGMP and Custom tiers. EQP allows us to classify products into these various ascending quality levels based on our ability to guarantee system controls at reasonable economies. This determines the level of change control we are able to offer and communicate. This helps us to advise customers and guide them in selecting products for their manufacturing applications that will meet their needs. Upper classification of the system use such international quality system standards as ISO 9001:2000, ICH, Q7a, and EDQM as guidance. The system also allows us to state definitely what we can't do - which is as important to be clear about as what we can do.
The products are selected and validated with customer input and guidance. At present, we are working to introduce cohorts of approximately 100 new EQP items per quarter with specific manufacturing applications in mind. The first round of EQP products is targeted for diagnostic manufacturing applications. The next cohort is aimed at products commonly used in Vaccine manufacturing.
Posted by Bruce Lehr Feb 21, 2010