New webinar highlights how to cope with challenges of quality agreements

Negotiating a quality agreement is time-consuming. Our recent webinar, "Quality agreements for pharmaceutical raw materials," was created to help inform you of the considerations you need to take into account for pharma raw materials, including understanding the expectations by regulatory authorities. Pragmatic approaches that can be used to reduce negotiation time by using templates offered by industry associations are also highlighted.

Quality agreements are legally binding documents between the pharmaceutical's manufacturer and its supplier and/or contract manufacturer. The purpose of these agreements is to delineate the two parties' quality-related responsibilities with regard to manufacture, testing and supply of pharma raw materials.

In recent years, regulatory authorities have begun strengthening their requirements for quality agreements because they have become such an important part of supplier qualification. The FDA has issued draft guidance describing its expectations, titled "Contract Manufacturing Arrangements for Drugs: Quality Agreements," and the EU has revised Chapter 5 of the EU GMP Guide, which requires the definition of quality-related aspects for the starting materials with regard to production, control and distribution.

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