How a Quality by Design model can benefit the dietary supplements industry

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Quality by Design (QbD) is a quality-assurance model centered on preemptively building in QA controls from beginning to end. QbD has captured the interest and following of global industries, including automotive and pharmaceutical, as well as the attention of regulators worldwide.

Christen Davis, director of quality, Lonza Consumer Health & Nutrition (Greenwood, SC), recently talked to Nutritional Outlook about how Lonza Consumer Health & Nutrition has implemented QbD, what it entails, and how this model can benefit all dietary supplement manufacturers.

Nutritional Outlook: As a capsules supplier, Lonza Consumer Health & Nutrition sources the ingredients required to produce its capsules and also, through capsule filling, often has an extended view of the ingredients filling a capsule. In this scenario, how does a QbD model fit in?

Davis: An integrated supply chain is the foundation of quality. Each unit contributing to the product-internally and externally-must be unified and aligned on product and testing expectations. They partner together to improve performance.

The cornerstone of a QbD model is to clearly define expectations with partners-and then require that they are met. For ingredients, Lonza CH&N searches out raw material suppliers who understand the regulatory guidelines for safety and efficacy. Manufacturers should do the same. We want to know we are receiving what we ordered, and so should any supplement manufacturer. One way to ensure this is to outline contractually enforceable purchase specification standards based on worldwide regulations and guidelines. Some of the key standards are:

• Identity: Is the ingredient actually what the supplier says it is?

• Strict purity criteria

• Impurity limits to include contaminants, elements, and solvents

• Viral safety guarantees for animal-derived ingredients (in our case, bovine for capsules)

• Biological safeguards as it relates to GMOs

• Controlled use or absence of allergens

The clearly defined standards can be applied to each and every supplier. The supplier should not be used unless it can meet these specifications with very little variation. This can weed out any bad apples and ensure consistency of product for a manufacturer.
 

What kind of quality assurance challenges has your company observed in the market?

Davis: In a QbD operation, all divisions are integrated and all are functioning at the top of their games. But challenges will and do arise. Here are some examples of what we have seen and heard-and our thoughts on solutions.

Capsule filling: When customers run their own capsule-filling operation, higher levels of defects can surface, ranging from ingredient leakage to cracked capsules. This can slow down filling speed and reduce yield, leading to waste and downtime. These issues can be solved with a QbD approach to matching the capsule-filling machine with the right capsule for the specific density and dosage amount for the ingredient.

Audit readiness: Unplanned audits can be tense. But an unexpected visit from a regulatory agency can be anticipated and “planned” for if a company sets up an Internal Audit Program (IAP). The IAP is a self-policing system that ensures cGMP requirements are met at every step. The IAP is a list of items checked and reviewed on a regular schedule. The checklist helps identify what is working and what is not working and needs to be corrected immediately. It also signals what could potentially go wrong, spurring preventive action to minimize corrective action. Red flags can be raised by the trends that emerge in regular periodic reports from internal tracking of the records kept by various divisions. When all departments and supporting operations are on constant lookout for issues as they arise, quality can be reinforced daily and a culture of “readiness” for audits can be cultivated.

Laboratory and manufacturing operations: Cleanliness and organization is imperative to ensuring a succinct quality program. When labs or operations are not using organized techniques, it only leads to more questions.
 

How can your company’s Certified Vendor Program serve as a model for enhancing quality and legal compliance? Can you describe some of the most important steps in such a program?

Davis: Lonza CH&N follows several key steps in the verification of a supplier from any region of the globe to assure the supplier meets our stringent cGMP screening that the material supplied is safe, pure, and effective. It includes:

• Creating a purchasing specification based on a validated method and assuring the supplier can meet it

• Thorough review of all documentation and descriptions of manufacturing processes

• Obtaining certifications from third parties like NSF cGMP, ISO 9001-2015, etc.

• Obtaining three consecutive lots of materials to test against the purchasing specification

• Performing onsite audits

All our vendors must go through the same level of scrutiny and meet the same standards as part of FDA guidelines.

As already stated, Lonza CH&N insists on security of capsule raw material. Our Supplier Selection and Qualification Program guarantees that our hard capsules meet the highest standards for quality, traceability, and integrity. This core five-phase program requires critical key raw materials suppliers to undergo an intensive, year-long selection and qualification process to make sure they meet the most stringent regulatory and industry standards that exist anywhere in the world. Here are the five components:

• Preliminary investigation: reviews the supplier’s quality system, state of manufacturing technology, and scope of products and services offered and determines the supplier’s performance metrics in details

• Manufacturing-suitability evaluation: assess the crucial issue of whether the supplier’s raw materials is compatible with Lonza CH&N’s manufacturing processes and protocols

• Production trial: use of supplier’s raw material in large-scale, high-volume production trials at various Lonza CH&N sites to confirm both finished capsule quality and manufacturing efficiency performance levels

• Onsite audit: full traceability exercise and quality system check to ensure compliance with applicable and Lonza CH&N standards

• Acceptance contract: formalizes the technical and commercial requirements and expectations, including both initial scale-up support and ongoing quality

Once suppliers are selected and qualified, we consistently monitor them to ensure ongoing quality. The evaluation process assures supply chain traceability and finished capsules that comply with the highest standards. The management involves constant testing and regular in-depth onsite audits.
 

How do these insights and quality-control best practices benefit the customers that work with the company?

Davis: Lonza has created white papers about its CVP and other quality initiatives. These have been shared directly with customers at trade shows and face-to-face meetings. In addition, they are available for review on our website and through online trade publication exposures. We also offer to directly pass on our knowledge to our manufacturing customers by showing them how to integrate processes from a QbD model to their operations where appropriate. We partner with them to establish processes that will help them to become more self-sufficient and successful. Our Quality Engineering Services (QES) can collaborate with them through the entire manufacturing process, from receiving raw materials to supplement applications and production to improving capsule-filling productivity to bolster profits.

As a more specific example, we can conduct an audit of a manufacturer to assist them in setting up a regulatory foundation for their operation. We also embrace customer audits and visits to our facilities to educate and openly show them our quality processes to better understand them so they can more easily adapt them to their own businesses. On-site visits help us both keep ahead of the latest regulations and be “audit prepared” at all times.

Finally, through spearheading and hosting a periodic Quality Summit, Lonza has stepped onto the national podium as a quality torchbearer and industry educator. At the events, we share our practices in presentations and Q&A panel discussions. We also bring together quality industry leaders to voice their opinions and fresh thinking about how to assure quality, adapt to regulatory challenges, manage risk, and develop best practices. The August 2017 summit hosted 80 quality professionals from North America at our Greenwood, SC, manufacturing headquarters for the Americas.
 

Why is it important for everyone in the supply chain, from the ingredient suppliers to the dosage provider to the contract manufacturer and the marketers themselves, to have a solid quality-control process and to consider implementing a QbD model?

Davis: First and foremost, because this is how to best serve the consumer. If all suppliers are in sync with quality-control processes, specs, and criteria, products can not only meet consumer expectations but work to exceed them. A brand can cultivate a reputation for going far beyond Acceptable Quality Levels and race far ahead of their competition. Consumers will catch on and keep spending for top-notch products that are known to be safe and effective.

Integrated quality controls throughout the entire supply chain allow a manufacturer to be “audit prepared” at all times. This is very good for business. Knowing their products would comply to regulations with flying colors, a manufacturer and brand can remain consistently competitive because their products can be released to markets confidently and quickly, without worries of shutdowns or recalls due to consumer complaints or unplanned visits from regulatory bodies.

A solid quality-control process is more economical. Sure, there are upfront time and monetary expenditures to set up processes and certify vendors plus ongoing outlays for upkeep and monitoring. But consider how expensive it can be without such controls. There can be costs for defects of products already released, product waste, unproductive labor, and excessive testing, as examples.

From this vantage point, the investment in a quality system can save a business money as well as yield dividends for reputation and business growth in the long run.