Instant GMP Compliance Series - What is Quality by Design?

The pharmaceutical manufacturing business is one of the most controlled and regulated industries in the world. Regulatory methods such as GMP (Good Manufacturing Practices), PAT(Process Analytical Technology), and the newest, QbD (Quality by Design) all ensure that pharmaceutical products are safe and of high quality for consumers to purchase and use.

QbD is the scientific background behind improving manufacturing process and thus the products through extensive and meticulous planning. Joseph Juran, a pioneer in QbD, stated that quality results are achieved through good planning. Recording errors in quality or processes can be charted and analyzed to improve quality. QbD practices are scientific and engineering based, rather than empirical testing practices which was used prior to QbD.

The PAT system was being used in the pharmaceutical industry prior to the implementation of QbD methods. PAT systems recognized that quality cannot be tested into pharmaceutical products; instead, quality should be achieved through proper design. The PAT system puts focus on the end results and testing, where QbD builds the quality through checks during the manufacturing process. QbD is effective because the process is improved through a deeper understanding of the processes through scientific and engineering analysis. The framework clearly defines a design and consequently controls and limits on expected outputs of processes.

Implementation:

Pharmaceutical companies are beginning to make the transition from empirical to scientific framework due to a deeper understanding of processes in manufacturing. Companies must have a good grasp on their entire manufacturing processes in order to implement a QbD framework.

There are varying levels of understanding that must be grasped prior to implementing an efficient new system.

1. Thorough Process Understanding:

A complete understanding of processes in the system must be based on multivariate analysis based on collected data. The parameters and checks in the process must be implemented once the origin of variability has been identified.

2. Quality by Design:

Processes must be based on design space (assesses the quality of a product) which is flexible in nature and can control deviations.

3. Work Process:

In order to properly execute a QbD process a set of specification and parameter infrastructure must be implemented. CPP (Critical Process Parameters) must be monitored during real time assessments to achieve proper quality management.

4. Constant Improvement:

Specialized teams must be created to work on a specialization, however, they must work together to ensure the big picture is taken into account. These highly trained teams must be experts in QbD modeling and simulations so that they can obtain relevant data and utilize it to improve the overall process.

Benefits:

QbD can provide multiple benefits for a pharmaceutical company, including:

• Reduced and managed risks

• Real-time quality assurance testing which results in quicker release of products

• Increased product quality and lowered product deviation rates

• Rapid transfer of data between development and operations

• Lower operation costs

• Reduced number of onsite regulatory inspections resulting in citations

• More effective complete life cycle management

• Continuous improvements and adjustments in overall processes

Challenges:

A QbD framework must overcome these challenges:

• Investments: QbD requires an initial investment in resources such as materials, manpower and time.

• Challenge of prior data integration: The multivariate analysis that QbD uses makes it difficult to utilize prior data mixed with the new data.

• Learning and training: Teams will need time to gain competency with the available tools and may find it difficult to have a thorough understanding of the processes, initially.

• Auditing: Auditing processes may be difficult until clear processes are created that delineate how results are attained.

An example of a QbD system is InstantGMP™. This system is an electronic batch record system geared for GMP manufacturing and founded on Quality by Design groundwork. The design team included experts in quality, manufacturing, packaging/labeling, engineering, and software design. The group designed and implemented standard operation procedures (SOPs) and quality policies into the system. These SOPS are hard coded into the software to ensure that GMP regulations are always met. The system is suited for pharmaceutical manufacturers producing active ingredient pharmaceuticals, OTC products, or generics and dietary supplements.

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