Customization of product specifications

Development of Pharmaceutical raw materials

Question

We would like to upgrade a reagent used in the development stage as a raw material for pharmaceutical products; however, the same material is not available in your lineup of raw materials for pharmaceutical manufacturing. Could you provide material with proper specification based on our request?　Furthermore, it is preferable if we can receive change notification when you have change on the item.

Answer

We will ask you about test items and packaging specifications you are considering for our feasibility assessment and propose product specifications we can securely meet. It is also possible to inform you of specification changes, whenever they occur, under conditions we both agree upon.

Outcome

In response to the customer's request, we have delivered a product That full fills desired specification and also provide change notification.

Addition of test items to the specifications

Question

We would like you to add endotoxin test to the specifications of the product.

Answer

It is possible for us to add endotoxin test to the current list of product specifications. It is also possible to add other tests you may wish to contract out such as sterility test. Acceptance criteria for the tests shall be established based on mutual discussion and agreement.

Outcome

We have delivered a customized product item for which the specifications include endotoxin test.