Cynthia A. Ipach, President and CEO
When the Food and Drug Administration (FDA) conceptualized its new division, Office of Pharmaceutical Quality (OPQ), their vision for OPQ reflected through their tagline, 'One Quality Voice.' FDA recently acknowledged that traditional facility inspections weren’t effective in predicting product quality, which eventually led to the establishment of this new division. Through OPQ, FDA has introduced a new inspection approach, New Inspection Protocol Project (NIPP), which describes and assesses a company’s state of quality. While the new strategy has indeed changed the regulatory paradigm of GxP inspections by standardizing data gathering during inspections, it has also raised several questions for pharmaceutical companies to answer. Questions about the quality, culture, and the way to directly measure its adequacy and improve it. As FDA ‘NIPP’ed inspection in the bud, it became mandatory for pharmaceutical companies to up their game to prepare themselves for the FDA approval. With its wealth of experience in handling FDA regulations and the will to transform the FDA regulated industries, Compliance Insight, Inc. supports its clients’ goals to close any gaps in quality culture.
"We are staying abreast of the changes in the regulations by working with the FDA and Industry to be on the forefront of the pharmaceutical and medical device regulatory landscape."
The company has partnered with key players to improve the supply chain performance benefiting both the patients and the participating manufacturers and suppliers. One of the goals of the initiative is integrated risk reduction. The Good Supplier Practices initiative is a collaboration of 39 leading pharmaceutical companies, the FDA, the USP, and other regulating bodies from 5 other countries. Compliance Insight is a co-leader on this project that was started by Xavier Health in 2012. There are high expectations that this will complete the GxP suite and will be soon adopted by the USP, and eventually the FDA.
Through alliances such as these, Compliance Insight creates a pathway for their clients to use novel technologies to abide by the FDA regulations and inspections. "For many years, we have been working with the FDA. We are on a panel with FDA for global supply practices which enables us to be involved in helping set precedence for new standards," says Cynthia A. Ipach, the President, and CEO of Compliance Insight, Inc.
Aligning with FDA, Made Easy
At the core, "We are staying abreast of the changes in the regulations by working with the FDA and Industry to be on the forefront of the pharmaceutical and medical device regulatory landscape, and to that end, our new tool, the predictive product quality (PPQ) system substantiates our idea," informs Cynthia. The company aims to achieve this objective by working with the key stakeholders in the client environment to proactively prevent or resolve FDA compliance issues.
Developed by Xavier Health and SchellingPoint Software, an advanced management consulting company, Predictive Product Quality model or PPQ, is a seven-step action determination system that leads to an action map for quality culture mitigation. Being a key distributor, Compliance Insight can help clients identify leading product quality risk metrics linked to patient safety that could be used to predict non-conformance events which could be discovered during an inspection. A key aspect of the PPQ model is the systematic approach used to determine the true leading quality indicators that should be present and practiced in an organization that is committed to quality--a direct reflection of the quality culture. Utilizing influence mapping and cause and effect analysis, these key leading quality indicators were identified by industry thought leaders. This model measures the organization’s sentiment and alignment around these indicators, across functions and throughout every aspect of the organization. “When clients go through the predictive product quality system model, it tells them where the communication breaks down and where disparities occur and helps everyone in the company to be on the same page, once the client implements the corrective actions," states Cynthia. The key deliverable is an action roadmap for augmenting quality which maps out exactly what has to be done to mitigate the quality culture gaps and ultimately helps them to align the company with the FDA’s inspection policies.
On another front, Compliance Insight has once again partnered with Xavier Health, the FDA and industry thought leaders to bring the concept of Artificial Intelligence to reality.
The goal is to work collaboratively to advance the pharmaceutical and medical device industries by augmenting human decisions with artificial intelligence such that decisions are more informed. The use of artificial intelligence will move the industry from reactive to proactive, then from proactive to predictive, and finally from predictive to prescriptive such that actions are right-first-time. Through the Xavier Health Artificial Intelligence Initiative, the industry will increase patient safety by ensuring the consistency of product quality.
Align, Apply, Adapt
Born out of the need for providing GxP services that go beyond the regulations, Compliance Insight helps companies by training and auditing them to redress the shortcomings in their organizational setting and ultimately make them ready for the FDA. "By aligning, applying, and adapting to our clients' context, we help companies create an environment that meets the regulations easily," mentions Cynthia.
Compliance Insight takes a comprehensive approach to deliver their compliance services. Cynthia elaborates that they listen to the clients first and comprehend their needs. "We want to understand how the problem is impacting them directly," she says. In one instance, Compliance Insight helped their client, a medical device firm, resolve the FDA Warning Letter by providing practical systemic enhancements and training that improved performance. The client wanted to resolve significant good manufacturing practice (GMP) observations first and then change their company culture to avoid a repeat observation in the future. Compliance Insight served the client’s needs with a strategic purpose and managed performance by bringing culture change catalysts to all levels of employees.
Code of Ethics, Code of Conduct
Compliance Insight differentiates itself in the market with its vibrant, employee-focused work culture. The company has a very experienced and competent workforce with the minimum tenure of each employee at 15 years in a FDA regulated environment. "We look for highly qualified industry and FDA professionals that can provide high-quality consulting services," states Cynthia.
Having gained significant traction from reputed industry leaders in the last couple of years, Compliance Insight aims to expand to markets outside the U.S. The company has recently created an alliance with an attorney group to deliver regulation consulting in South America, Europe, and INDI-SAP regions. "We will be venturing to build our expertise outside the U.S. to support companies that want to produce pharmaceutical and medical device products and market them extensively," concludes Cynthia.