How to keep quality control (QC) independent from production in the move to real-time testing

Pharmaceutical and biopharmaceutical products are monitored throughout manufacturing – they are tested during manufacture and before release to the market. The specific requirements governing the performance of these and other quality-determining activities are detailed in statutory GMP requirements, which are further described by the pharmaceutical quality system (PQS) of each manufacturer.

Industry needs to understand the key areas where real-time release testing (RTRT) will impact the PQS and some potential solutions to ensure the objectives of the PQS and patient safety can be maintained.

This paper has been written to address the compliance challenges of RTRT and the continued compliance with GMP standards.

To evaluate these challenges, we have reviewed the current quality guidelines that apply to RTRT and considered the areas and activities that will be impacted by an RTRT process. We have not included specific details of accountabilities and responsibilities for RTRT as we believe these will not be significantly different from how we operate today. Rather, it is the type of information used to support quality decisions and the source of this information that will change with RTRT processes.

Is the PQS suitable for defining the standards and operating guidelines for a real-time release process?

We think the answer is ‘Yes’ as the overarching quality principles are the same, but the detailed elements that a quality professional will need to have responsibility for will be different in many cases. We have outlined some of these differences and proposed potential solutions.