In the field of pharmaceutical manufacturing, the work of analysts is covered by a quality agreement, prepared by the staff of the quality control or quality assurance department, focused on the laboratory analyses provided. But what exactly are quality agreements, why do we need them, who would write them down and what should they contain? Here we answer these questions. Quality assurance should prepare the agreement with manufacturing and laboratory staff on both sides. The functions of the SQ of both parties should review and approve the quality agreement. Nothing should be taken for granted. Each party must review the quality agreement to ensure that its requirements are taken into account. In order to reduce the possibility of a misunderstanding, a glossary defining keywords and abbreviations is an essential element of a quality agreement. Quality documentation may contain guidelines to describe the requirements that need to be met; Process documents detailing activities that meet political requirements; Procedural documents explaining some of the actions necessary to accomplish a task in a way that yields consistent results; and policies to provide additional information, instructions or tools to support various activities in a manner consistent with documentation at a higher level. Additional documents such as information registration forms, document creation templates and quality meeting synthesis documentation are also very informative. The agreement should clearly define routine, escalation and emergencies and how they will be treated.
The agreement must also define what happens in the event of disputes that may be raised by both parties and document the mechanism for the prompt and effective resolution of disputes. One of the ways in which each role is exercised is to define it in the agreement, which can be literally. An alternative is the use of a RACI matrix (very “racy”) that is responsible, responsible, consulted and informed. This approach defines the activities participating in the agreement and assigns the corresponding activity for each role.