By Ron Branning, President, Ron Branning Consulting, LLC
“Tell me about your quality system.” The answer from your outsource partner can help determine their acceptability as your supplier, CMO, or contract test lab. They should be able to articulate how their operations are organized, what procedures are in place for critical functions, and whether or not there is monitoring and control for key activities. If this oversight takes place within an integrated quality system it provides valuable insight into the firm’s focus on management, attention to important details, and operational governance.
While comprehensive quality systems are perceived as too large, bureaucratic, and complicated to be universally applicable, a measured approach is the most successful way to construct a robust system. Development of individual system elements and integrating them into an appropriately sized quality system can be a path for formalizing your current approach or assessing and enhancing your existing quality system. This incremental approach starts with the creation of a framework for the initial quality system structure, usually based on the ICH Q10 pharmaceutical quality system guidance. The template for your quality system can then be used as an efficient outline and yardstick to assess your outsource partners.
An appropriately constructed quality system starts with a high-level operations flow chart which describes how regulatory expectations (GXP) and industry standards (cGXP) are embodied in departmental procedures. Critical activities and interactions are identified on the flow chart using a defined risk assessment process (ICH Q9). High-risk situations require layered backup procedures, particularly in the most critical circumstances, where multiple levels of monitoring and control are needed. This systematic approach not only provides for efficient routine operations but also acts as a safety net for management that identifies, controls, and minimizes the impact of unexpected events through predefined procedures.
Core quality system elements and essential deliverables that you should expect from your outsource partner, depending on their responsibilities and expertise, include:
- Development — creates a process with critical quality attributes (CQAs) and critical process parameters (CPPs) plus routine monitoring and control parameters. Analytical tools, that include specifications, are also developed by this group to control product quality.
- Engineering — constructs facilities for production based on development’s CQAs and CPPs including manufacturing monitoring and control systems.
- Manufacturing — develops batch record documentation and process validation based on development’s CQAs, CPPs, routine monitoring, and control parameters as well as in-process testing requirements.
- Quality Control — validates analytical tools transferred from development for use in both manufacturing in-process testing and QC lab testing of production samples for material and product disposition.
- Quality Assurance — is responsible for oversight of all activities up to and including assessment for materials and product disposition.
If you determine, using the quality systems assessment approach, that your outsource partner is deficient in their respective responsibilities, additional verification may be needed to ensure that sufficient controls are in place for the material, product, or service being provided. While your outsource partner is responsible for those activities delegated in the agreed contract, you as the license holder, are accountable for compliance including data integrity, product quality, and patient safety.
So now that we have used a quality system approach to assess your outsource partner’s capabilities, it’s your turn to look in the mirror and ask yourself — “Tell me about your quality system.”
About The Author:
Ron Branning has over 45 years experience in the BioPharmaceutical Industry serving in his most recent positions as Chief Quality Officer, Compliance Officer and Global SVP Quality. He brings a wealth of worldwide Quality experience in devices, drugs, biologics, and biotechnology and combination products in all dosage forms. Ron’s career has been focused on resolution of significant quality issues and implementing Quality Systems that are designed to ensure compliance and rapid new product approval.