Quality by Design and Compliance Readiness - How will implementing Quality by Design strategies affect your compliance status? - BioPharm International


Quality by Design and Compliance Readiness
How will implementing Quality by Design strategies affect your compliance status?

BioPharm International
Volume 23, Issue 1


Knowledge management in the quality system should help produce higher value information, better decision-making, and more organized, easily retrieved documents. The type, frequency, and contents of documents and the documentation process present some of the most vexing questions for companies. Although there are no clear-cut answers, documentation is tightly tied to QRM. As ICH Q9 says, "the level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk."

What this suggests is that documents and documentation processes should be flexible, yet provide guidance on decision-making based on risk assessments, process inputs, laboratory data, and other data. That means adapting cGMP records to capture scenarios and data, risk assessments, decisions, and justifications, rather than simply the data that are commonly recorded. For example, the practice of reviewing a single batch record as it was executed does not allow for the monitoring of trends or of overall process execution. Conventional documentation audits are restricted to uncovering documentation practices and verifying individual calculations. They do not provide an adequate picture of the process capability or the overall capability of the manufacturing team and equipment.

Thus, the addition of knowledge management and QRM to quality systems elevates compliance considerations to a higher level, moving away from document execution to document content, effectively shifting the focus of compliance from the management of paper to the management of knowledge.

As with the implementation of QRM, knowledge management should be incorporated into current systems to minimize operational and cultural disruption. Comprehensive knowledge management may require some new systems, but the goal is to bring data together to enable its conversion into knowledge, not to create yet another place to put data.


The change control process should be designed to enable the staff to:

  • Establish what level of review is required at each stage of development to determine whether the process and product are within the design space.
  • Decide when trends toward the limits of design space require a change in input variables or process parameters.
  • Evaluate, justify, and record changes.
  • Distinguish changes that require regulatory approval and those that do not.
  • Capture data outputs as a result of changes.
  • Prospectively assess the effects of changes on process capability and product quality for the longterm.

An effective change control system that achieves those objectives will also work with the knowledge management system to make a significant contribution to the overarching goal of continuous improvement in the process and product.

Change is, after all, inherent in the development process and should be used to gain knowledge and improve product quality. Traditional quality oversight in development would check and audit notebook citations and technical reports, which is not very useful for gaining product and process insight. Instead, QA might put out a guidance for how change information should be captured and communicated. The rigors of this process and experimental justification should be commensurate with the phase of development.

Chester A. Meyers, PhD, is a managing consultant, and Debra Weigl is a senior consultant, both at Tunnell Consulting, King of Prussia, PA, 610.337.0820,

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