Ensuring all drugs meet quality standards before entering the market is a cornerstone of public health. Depending on where you will be marketing your drug, these standards are strictly regulated by Health Canada and the U.S. FDA.
A critical step to manufacturing drugs that meet these quality standards is through a pharmaceutical quality system (PQS).
According to ICH Q10, section 3.1.3, PQS: “assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.”
In other words, PQS are critical to ensuring drugs are manufactured to meet quality and performance standards as mandated by regulatory authorities.
In fact, pharmaceutical quality is so important that during FDA inspections, the PQS is assessed as a key factor for supporting drug submissions.
A robust pharmaceutical quality system consists of the following 4 pillars:
1. Implementing Quality-Driven Processes
The foundation of any Pharmaceutical Quality System begins with quality-driven processes. These processes ensure that every aspect of drug development is conducted within established frameworks designed to meet regulatory standards.
The system is typically overseen by a dedicated team of Quality Assurance (QA) professionals who are responsible for ensuring that all experimental work is performed and documented according to validated standard operating procedures (SOPs).
In practice, this means every stage of drug development—be it preclinical testing, clinical trials, or manufacturing—follows a prescribed process. Each step is documented thoroughly, and data are reviewed systematically for accuracy, consistency, and adherence to industry regulations. This pillar establishes the systematic approach to production, guaranteeing repeatability and reliability, which are key factors in regulatory inspections and drug approvals.
2. Maintain a Clean & Safe Environment
A crucial part of quality assurance is ensuring that the physical environment where drugs are developed, tested, and produced meets stringent cleanliness and safety standards. This pillar focuses on environmental control, which includes ensuring that laboratories and production areas are maintained in a way that minimizes the risk of contamination, cross-contamination, or any environmental factors that could compromise the quality of the drugs.
At Custom Biologics, for instance, controlled access to all work areas is restricted to authorized personnel only. This is complemented by routine environmental monitoring, such as checking for particulate matter or microbial contamination in the air and surfaces.
Equipment calibration and preventive maintenance are also part of this process, ensuring that every tool and piece of equipment used during the testing and manufacturing phases operates according to its specified performance standards.
Maintaining these high standards of cleanliness and safety ensures that the data generated is trustworthy and that the drug products meet the required quality benchmarks.
3. Communication, Transparency & Integrity
Effective communication is paramount to a robust PQS. This pillar emphasizes the importance of transparency, both internally within the organization and externally with clients and regulatory bodies. For pharmaceutical companies, clear, open lines of communication ensure that any issues or challenges in the development process are quickly identified and addressed.
At Custom Biologics, this principle is put into action through regular project review meetings and detailed study protocols. These meetings ensure that clients are fully informed of the progress of their projects and any potential issues that may arise. This transparency is vital for building trust with regulatory agencies and clients alike, as it assures them that all processes are being conducted properly and in compliance with the necessary guidelines.
Moreover, maintaining integrity in all dealings, both with clients and regulatory bodies, is a core value. Pharmaceutical companies must adhere strictly to ethical practices, ensuring that all data reported are accurate, verifiable, and comply with regulatory standards. This approach is essential for building long-term relationships and gaining regulatory approval
4. Consistent Quality Across All Our Platforms
Finally, the consistency of quality across all platforms, experimental procedures, and laboratory equipment is essential. This pillar ensures that all scientific instruments used in drug development are compliant with industry standards and regulations. The equipment must be properly installed, calibrated, and maintained throughout its use.
In addition, regular preventive maintenance schedules for equipment and routine checks for consistency in experimental results are key aspects of this pillar. By adhering to procedures such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), companies ensure that the equipment used is not only compliant with regulatory standards but also consistently reliable.
Conclusion
At Custom Biologics, we boast a world-class PQS. Our independent Quality Assurance Unit (QAU) implements the latest regulatory guidelines for bioanalytical and biological assay validation, and routine scientific analysis to ensure the quality, traceability and integrity of the data. These high standards are met for work conducted in the course of research and development or for submission to a regulatory agency.
For more information about how Custom Biologics can support your drug development process, reach out to our experienced team to discuss your bioanalytical needs and regulatory requirements.
