What Is Quality Agreement
In May, the Food and Drug Administration (FDA) released a new draft industry guidelines entitled «Contract Manufacturing Arrangements for Drugs: Quality Agreements» (1). I like the way the title rolls out of the tongue, don`t I? You may be wondering what this has to do with spectroscopy, or even an analytical laboratory, which is a fair question. The answer is on page 1 of the document, which defines the term «manufacturing,» including processing, packaging, breeding, labelling, control and operation of the «quality unit.» Is the light bulb already on? The testing and operation of the quality unit – could these terms mean that a laboratory is involved? Yes, I do. v Life cycle and review of quality agreement Manufacturing quality agreements are comprehensive written agreements between the drug manufacturing parties that define each party`s manufacturing activities and determine how each party respects cmIM. The quality agreement must be developed and mutually accepted by the CMO and the customer prior to the acceptance of the supply contract, in order to ensure the identification of all invoiced items and any capacity restrictions. Figure 1 outlines the abbreviated requirements of Chapter 7 of Chapter 7 of the EU GMP with respect to the client or owner and the contractor or entity mandated to carry out the work. The responsibilities of the owner are sketched on the left side of the image and those of the delegated installation on the right side of the diagram. The content of the contract or quality agreement is presented in the lower part of the figure. These points will be discussed in the rest of this section. There are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, which are tailored to the relevant aspects of the type of relationship. The guidelines encourage homeowners to verify and approve most changes before being implemented. But in certain circumstances, there are changes that contractors can implement without notifying the owner. A quality agreement must determine how all these changes are made and managed.
The FDA acknowledges in the findings of the draft guidelines (1) that quality written agreements are not expressly mandated by GMP rules. However, this does not free any of the parties from their responsibilities under the GMP, but a quality agreement can help both parties throughout the contract analysis process – defining, defining and documenting the roles and responsibilities of all parties involved in the process. On the other hand, quality agreements concluded by the EU under the GMP constitute a legal and regulatory requirement. The supplier quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and good manufacturing obligations (GMP) of the design owner and supplier. A quality agreement is an essential part of a supplier qualification program, but it does not replace the supplier`s qualification processes (including audits when needed) or the supplier`s understanding of its processes and skills.