Pharmaceutical and biotech companies struggle with the difference between quality and compliance. It’s understandable. They’re interrelated concepts that frequently overlap. Both are critical to ensuring the safety and efficacy of drugs. However, the two have distinct meanings and functions and, in practice, bring different results.

An excessive focus on compliance alone can lead to a rigid approach that creates costly waste and undermines innovation and the development of cutting-edge medications. On the other hand, focusing only on quality without an eye on compliance can produce regulatory logjams and potential legal issues.

Pharma manufacturers, drug sponsors, and decision-makers know that each dose of medicine must be safe, effective, and free from contamination and defects. Patients are counting on it. To reliably accomplish these goals, the differences between compliance and quality must be understood, bridged, and balanced. 

Building a balanced approach begins with understanding the difference between compliance and quality and the difference between detecting non-compliance issues and proactively preventing problems.

Does Compliance = Quality?

Quite simply, no, compliance does not equal quality. Compliance is following and measuring against an external requirement imposed by regulatory bodies, while quality is an intrinsic characteristic of a drug.

Compliance and Detection

Pharmaceutical compliance focuses on audits and inspections to detect whether a drug meets the minimum requirements of laws, regulations, and industry guidelines – set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) – to be safe and effective.

Compliance entails adhering to all the rules and regulations related to drug manufacturing, labeling, advertising, and distribution. Non-compliance can result in fines, product recalls, or even criminal charges, so it’s easy to understand how manufacturers can get tunnel vision on compliance.

However, focusing only on compliance with laws and regulations is a myopic approach, leading to a rigid check-the-box mentality that centers on passing inspections rather than centering on patient needs. Manufacturers in this mode fall into an endless cycle of fixing (rather than preventing) issues. Such a narrow view allows room for quality issues, rejected batches, and recalls and translates into an unsafe and unreliable supply chain. 

Quality and Prevention

Quality in the pharmaceutical industry refers to the overall excellence and reliability of a product or service. A quality mindset takes a systemic approach to encompassing all aspects of the drug manufacturing process. It starts with the sourcing of raw materials through all manufacturing processes and their interdependencies to final packaging and distribution.

Maintaining quality ensures that the drugs produced are safe, effective, and consistently meet patients’ needs. Accomplishing this includes conducting rigorous testing and analysis to verify the drug’s identity, purity, potency, and stability as well as adherence to standards and specifications.

The future of the pharmaceutical industry lies in embracing a prevention-driven quality culture that implements and practices:

• a mindset of continual improvement and a sense of accountability for quality outcomes.
• a well-designed quality management system (QMS) balancing consistent quality with compliance.
• reliability in getting the product to market on time, every time.
• implementing technology and automation to streamline processes and reduce human errors.
• staying abreast of regulatory changes and responding proactively to signals indicating changes in requirements.
• a shared responsibility for quality at all levels of the organization.

This approach doesn’t ignore compliance, far from it. It simply folds compliance into a proactive quality system where regulations are adhered to with the understanding that they represent minimum requirements, not the product excellence goals a quality system will achieve. Quality control and quality assurance checks and balances ensure that each step of the manufacturing process meets or exceeds the required standards and specifications. Process metrics and controls happen in real-time, serving as an early warning system alerting manufacturing that adjustments must be made before the product is out of specification. 

An Ever-Evolving Future

Change is the only constant. Medicinal needs will change. Patient expectations will change. Technology will change. Regulations will change. They will evolve and transform into increasingly sophisticated QMSs aligned with an organization’s strategic plans and evidence-based decision-making.

Integrating Quality and Compliance for Success

Pharmaceutical and biotech companies can’t always build a Quality Management System and culture while meeting regulatory requirements or achieving FDA approval on their own. That’s when partnering with the team at Pharmatech Associates is a wise choice.

Our expertise in integrating compliance and quality into quality systems and organizational cultures enables you to successfully navigate the complex regulatory environment and produce safe and effective drugs. We work with you to strengthen both the quality and compliance aspects of your drug development and manufacturing processes, ensuring safety, efficacy, and regulatory compliance. We’ll assess your present level of compliance and quality management, determine opportunities for improvement, and craft a phase-appropriate tailored roadmap to achieve your goals.

We ensure you are ready to submit your product application and prepare for a regulatory inspection by:

• Understanding the details and nuances of the regulations.
• Keeping abreast of regulatory changes and proposed changes.
• Knowing how to shepherd applications through the US FDA and other regulatory agencies.
• Providing cGMP training for your employees.
• Conducting mock audits to prepare for when the FDA shows up.
• Completing supplier and internal audits.
• Evaluating Quality Management Systems through holistic gap assessments.

Contact us to ask any questions and support your journey towards quality.

Pharmatech Associates is a global consultancy for the life sciences industry and advises U.S. and global drug sponsors and manufacturers that supply quality medicines in many major markets. Pharmatech is the only life science consultancy owned by US Pharmacopeia. The foundational knowledge that USP possesses combined with Pharmatech’s expertise makes us a one-of-a-kind consultancy.