Any strong agreement should have a defined conflict resolution process. While no one wants to set up a conflict resolution process, the time is to develop these processes long before you need them. In fact, only by having them on site can you avoid problems on the road. You also need to be sure that your agreement determines exactly what comes with the materials they deliver, in what degree of purity, to what extent and within what delivery time. What kind of process validation do you need? Do you need in-process information or just a certificate of analysis for the final product they provide? It is important that you tell what should be included in the certificate of analysis to prove the identity, quality and purity of the product. A sufficiently detailed quality agreement can help to avoid assumptions leading to conformity errors. While a quality agreement defines the specific quality parameters of a project and which parties are responsible for its execution, the degree of detail varies depending on the development phase of the project. A quality agreement should at least delineate the obligations and responsibilities of each party in the following basic elements: authorSiegfried Schmitt, Principal Consultant, PAREXEL International, discusses the importance of quality agreements. In today`s competitive environment, pharmaceutical companies are increasingly outsourcing the production of APIs and formulations.

In such cases of contract manufacturing, the EU Guidelines on Good Manufacturing Practice invite companies to sign a technical agreement setting out the roles and responsibilities of the parties concerned with regard to the manufacture and control of medicinal products. A GMP technical agreement ensures compliance with current best practices (cGMP). Ensure that your technical agreement covers all of the following aspects:- Packaging material control methods and specifications- Packaging material inspection – Appropriate labelling, verification and authorisation methods- Packaging instructions, procedures and documentation- Analysis of finished products and documents prior to publication- Annual product review – Management of complaint specifications for recalls and product decisions Intro products duction- Management of returned products- Prevention of environmental pollution Finally consider monitoring the effectiveness of agreements by clearly defined metrics. In each case, these metrics could include on-time and complete delivery (95% target) and the number of audits per quarter in arrears (target not exceeding 1; not for critical suppliers). An effective quality agreement defines the specific sites on which the contracting establishment will carry out manufacturing operations, including specific services to be provided at each site. It is not because activities are outsourced, even to other entities within a company, that a company is removed from its responsibilities. On the contrary, a biopharmaceutical company must continue to assume its responsibilities and quality agreements are an important means of ensuring and maintaining this control. . . .