Preparing to Adopt a Quality Agreement

August 2, 2018

A major challenge at the contract lab (CRO) is to handle Quality Agreements (QAGs) through some standardized procedure, while at the same time allowing for the diverse needs of a wide client base.  This becomes more evident when one considers that the QAG typically originates with the client, in their format, and therefore contains many client-specific idiosyncrasies.  Furthermore, the contract lab may be performing laboratory testing under GLP, GMP and/or ISO laboratory testing protocols, which, although greatly similar to one another, will each have its own unique requirements.  Procedures, to be useful, must be detailed enough for personnel to be trained on and to follow. However, to be standardized across the wide client base, they must not be too detailed.  One cannot have a procedure for each client.  Management must therefore “see the forest for the trees”.