So now you have a Warning Letter or worse, a Consent Decree and you need a strategy to move forward. What do you do?

In order to develop a sustainable methodology that will ensure the appropriate outcome, one needs to develop a cGMP masterwork plan that will crystallize key principles and functions that will be used to assure consistent and reliable implementation of remediation activities. This should involve the establishment of lead teams, drawn from the company personnel and third party consultants, that together will take responsibility for the identification and resolution of tasks and activities assigned to remediate a particular quality system element. In consultation with the company senior management, the expert consultants should create a cGMP masterwork plan that will provide the direction of the remediation activities and ensure comprehensive and consistent rollouts of the overall remediation strategy. Each individual quality system element remediation activity should be guided by an expert consultant and driven by an individual company manager with line functional responsibilities. Oversight support for the approach should be provided by the company senior management.

The objective of the cGMP masterwork plan approach is to cause a paradigm shift in the way the company runs his business from a compliance perspective and to incorporate all modern industry practices and regulatory expectations to bring the company operations into the mainstream. In gathering the raw data to build the individual quality system element remediation activities, the expert consultants will mentor the company employees in the skills required to recognize symptoms of systemic deficiencies. The intent of this process is to transition the understanding of modern cGMP expectations to all company employees so they will be able to maintain the process systems once they have been commissioned. For each of the quality system elements to be remediated, the staff will work with the expert consultants to identify the necessary steps to first neutralize and then remediate the problem to assure sustainable compliance going forward.

To properly define the new company quality management system the individual quality system elements can be broken out and tabulated to provide a systematic understanding of the basis upon which the quality system will be built and operated.

Once the collection of quality system elements is defined for the company’s quality management system there is now the basis of the structure for the cGMP masterwork plan. These individual elements taken together and managed as an integrated unit form the fundamental principles upon which cGMP compliance is based in separating out the quality management system into these individual elements, the company acknowledges that there will be areas of overlap that will be complementary and which will add an extra level of security to ensure that prevailing compliance standards are met. In some cases, for example, that will be aspects of that content which may lie within the scope of several elements. Training is a good example. Training will fall under the training quality system element as well as under other elements where training will be a key component to enable the specifics of the system to operate appropriately. As a result of this interdependence of the individual system elements, it must be understood that the cGMP masterwork plan is an integrated document rather than just many independent sections. This approach will assure full compliance according to the prevailing regulator expectations.

With this in place one now has the foundational strategic document defined which can be used to drive the whole process to a successful outcome.