Quality by Design (QbD) in the Pharmaceutical Industry

Quality by design (QbD) is often associated with construction projects. The idea is to develop processes that support quality throughout the construction project from planning to building to operations.

In the pharmaceutical industry, the U.S. FDA has taken significant steps to adopt QbD principles in their pre-market processes that guide the approval process.

In fact, in April 2017, the FDA released their findings of a QbD pilot program that indicated “strong alignment” with the continued implementation of QbD design concepts.

The FDA is even rewarding companies that adhere to QbD principles to improve the reliability of production, reduce the risks associated with manufacturing products, and increase safety for the end user.

QbD in Pharmaceuticals Streamlined to One Quality Voice

One of the most significant steps the FDA has taken to adopt QbD principles is creating “one quality voice,” as administered by the Office of Pharmaceutical Quality. The OPQ sets the standard for “a uniform drug quality program across all sites of manufacture and across all human drug product areas.”

By establishing uniform guidelines throughout the process, the OPQ can efficiently evaluate production quality from the beginning, not at the end of the process. This approach allows the OPQ to provide a “single, more informed quality assessment” to identify problems that require correction in the early stages.

The FDA is also better equipped to focus on the supply of medicine for Americans. By integrating a review process before manufacturing begins, the OPQ can (a) balance potential quality risks with the risk of the patient not receiving a necessary drug and (b) anticipate quality problems to help prevent drug shortages.

How is the FDA Rewarding QbD in Pharma?

The FDA is looking for manufacturers to align with their focus on Quality by Design by expediting new drug applications if manufacturers demonstrate the use of QbD principles, product knowledge, and understanding of processes.

Additionally, manufacturers that practice QbD can benefit from the shared knowledge gained from the Process Validation approach adopted by the FDA. In 2011, the FDA issued their Process Validation guidance that was centered on this mindset:

  • Ensure that quality, safety, and efficacy are designed or built into the product manufactured.
  • Quality cannot be adequately assured merely by in-process and finished-product inspection or testing.

Essentially, the FDA is following through on their desire for early quality integration by guiding manufacturers on how to validate their processes well before production begins; inserting quality as early as construction.

Then, by gathering critical feedback and performing analysis, manufacturers can continually improve to increase quality throughout the life cycle of manufacturing.

AMLS Offers QbD Through Early Quality Integration (EQI)

AM Life Science (AMLS) is knowledgeable and experienced in utility and equipment commissioning and qualification. When AMLS functions as an integrated part of Construction Management Division, we are able to bring a quality voice to the table at all construction decisions.

AMLS Offers Process Validation for Pharma

AM Life Science (AMLS) is knowledgeable and experienced in process validation for pharmaceutical production. Our expertise includes authoring and executing the PV documentation:

  • Process Qualification: Evaluating the process design to determine if it is capable of repeatable commercial manufacture, including facility design, equipment qualification, and process performance qualification (PPQ).
  • Continued Process Verification: Ongoing verification that the process produces a product that consistently meets specifications.

To learn more about how we follow and apply QbD in each project, we invite you to download our whitepaper, Early Quality Integration.