Why Is Quality Management System Due Diligence Important?
Quality Management System (QMS) due diligence is crucial for organizations seeking to establish and maintain a strong foundation for quality, compliance, and overall business success. By regularly assessing and improving the QMS, organizations can navigate challenges, seize opportunities, and build a reputation for excellence in their respective industries. Quality Management System due diligence is an important part of any pharmaceutical quality management system. It helps to ensure that the system is fit for purpose and compliant with relevant regulations.
What Is Due Diligence?
Due diligence is a process used to assess the quality of a pharmaceutical quality management system. It is important to conduct due diligence when considering a new pharmaceutical product or supplier. In addition to using iCH Q10 as a checklist for the quality management system, due diligence reaches deep to ensure that the quality system achieves its stated objectives to ensure that the pharmaceutical product meets all regulatory requirements and that the supplier has a good track record of producing high-quality products.
What Are The Requirements For Pharma Due Diligence?
The requirements of the pharmaceutical quality system are summarized in ICH Q10, a European guidance that has acceptance in the U.S. with the FDA (Food and Drug Administration). When QMS due diligence is not followed, pharmaceutical companies pay the price in the form of regulatory action, product recalls and loss of market share. Therefore, regular due diligence reviews are a cost-effective investment.
Because the pharmaceutical industry is highly-regulated, it is not enough to simply perform due diligence. A pharmaceutical quality system cannot sustain itself without conformity to regulatory requirements. Requirements vary from country to country, with common elements.
GMP Requirements
The GMP requirements for pharmaceutical quality management systems are laid out in EudraLex Volume 4, European Union’s directive on Good Manufacturing Practice. In the United States, GMPs are codified in 21 CFR 210 and 211. 21 CFR 211, ”Current Good Manufacturing Practice for Finished Pharmaceuticals,” sets out specific requirements for aspects of pharmaceutical quality management such as personnel, buildings and facilities, equipment, materials, production and process controls, packaging and labeling, storage, shipping and tracking of shipments.
GMP requirements are even more prescriptively laid out in ICH Q7, but this standard is most commonly used as an aid, since Q7’s focus is on production of the Active Pharmaceutical Ingredient (API). Q7 can be used as a guide to help interpret the meaning of some of the general requirements laid out in EudraLex and/or 21 CFR 211.
EU GMP Guidelines
According the European Union’s GMP Guidelines, quality systems must be designed and implemented in a way that takes into account the:
- Size and structure of the pharmaceutical company
- Nature of the pharmaceutical products
- Pharmaceutical processes used
In addition, the quality system should be able to demonstrate continuous improvement. This means that it should be regularly reviewed and updated in line with changes in technology, processes, and products.
Due Diligence Assessment: What To Consider
Before mergers and acquisitions, assessments help to ensure that the company is a sound investment to the acquirer with no hidden quality costs to degrade company value.
While it is understood that the quality management system of the acquired company will not be identical to the acquiring company, it is important that the quality management system meets certain minimum requirements. Meeting these requirements further prevents costs by proactively identifying and mitigating associated quality risks.
Four major factors constitute a due diligence assessment of the a pharmaceutical quality management system. These include:
Scope
The scope of the Quality Management System (QMS) is a critical consideration in the realm of pharmaceutical manufacturing, as it directly influences the effectiveness of ensuring product quality, safety, and regulatory compliance.
Reliability
The reliability of a Quality Management System (QMS) is a pivotal factor in ensuring the consistent delivery of high-quality products and services. Assessing the reliability of the QMS involves an exploration of how often quality issues arise and the efficacy of the processes in place for addressing and resolving these issues.
Effectiveness
The effectiveness of a Quality Management System (QMS) is a key determinant of its ability to consistently meet all quality requirements. An effective QMS ensures that processes are well-defined, monitored, and continually improved to meet or exceed established quality standards.
Robustness
The robustness of a Quality Management System (QMS) is a critical aspect that reflects its ability to adapt and effectively cope with changes, whether they involve the introduction of new products or modifications to existing manufacturing processes. Evaluating the robustness of a QMS involves assessing its resilience, flexibility, and responsiveness to change.
Have You Done Your Due Diligence?
A well-functioning pharmaceutical quality management system is critical to ensuring the safety, efficacy and quality of pharmaceutical products. By preventing problems before they have an opportunity to create harm, due diligence manages risks that cost the company in recalls, product failures, and most importantly reputation risks that can implode the entire organization.
Due diligence inspections on a pharmaceutical quality management system can be complex because it requires broad understanding of both regulatory requirements and pharmaceutical manufacturing processes. Acquirers will want to engage specialist consultants to assist with this process.