Specifications answer the questions, “What does it take to prove the quality of a given substance?” and “How should the proving be done?”. There are different specifications in regulated industries, and keeping track of them can be difficult. That’s why businesses try to maintain stringent specification systems.

A rigorous specification system contains the following information:

Specification information should be easily accessible to those managing material receipts, as well as the Quality Manager. The QM is responsible for the status of the material.

It’s important that the tests and methods be correct for any given material. One of the most frequently cited deficiencies in FDA audits is the lack of the appropriate material tests. For the USA, the “mother lode” of this information is the US Pharmacopeia. A worldwide list of similar resources is shown here. It’s also important that the tests and methods are complete for all materials, especially those involving recently added ingredients and products.

Here at InstantGMP, we have an inventory system that requires a specification review for all regulated products, raw materials or finished goods. This ensures that all material receipts are correctly labeled by status for all processes going forward. It also ensures that specifications in regulated industries are being met. In compliant businesses, good material management will lead to good material rewards.

 If you want to learn more about our specifications and how they work in our CFR based inventory workflow, just contact us at www.instantgmp.com.