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ROI CalculatorBiopharmaceutical companies must comply with all good manufacturing practices (GxP) requirements. Therefore, they must ensure that all products are manufactured, tested and supplied using controlled conditions and via methods that allow for an accurate system of tracking the supply chain. In the US, biopharmaceutical companies are primarily governed by the FDA's good manufacturing practices (CGMPs) within 21 CFR Part 210 and 21 CFR Part 211 (FDA 2020).
Many companies have developed their pharmaceutical quality systems globally in accordance with ICH Q10 to accommodate different pharmacological products. The basis for ICH Q10 is ISO-style quality processes over the entirety of the product lifecycle. ICH Q9 provides rationale for using risk-based decision-making.
Quality must be regarded as a critical factor when manufacturing biopharmaceutical products. Biopharmaceutical quality management is especially important today because it can help to provide assurance that products are safe and efficacious and leads to companies developing high quality products. Customers, physicians, other healthcare professionals, and patients want to know that biopharmaceutical manufacturers will prioritize safety and efficacy when developing products and that they have provided documented evidence that proves they have done so.
Biopharmaceutical quality management has become important for mitigating business risks above and beyond sales dollars. Implementing a quality-first structure to manufacturing can help to eliminate most preventable adverse events from occurring; when an event does occur, the biopharmaceutical company can react to the event quickly so as to minimize the impact of the event.
Quality systems, documentation, and data integrity are essential to enabling biopharmaceutical manufacturers to produce products that meet high standards of quality as well as ensure patient safety and compliance with regulatory authorities.
A sound framework for a quality management system includes a documented quality policy and set of quality objectives, a quality manual with an established set of quality standards and procedures for regulating product quality, an organizational structure that defines the roles and responsibilities of employees, procedures and processes for controlling internal operations, patient satisfaction metrics, and mechanisms for continuous improvement.
Documentation is critical to maintaining quality standards and ensuring traceability. Some of the most important documents include SOPs, batch records, quality control records, training logs, equipment maintenance and calibration records, change control documents, and records of complaints and investigation of complaints. These documents establish a documented history of how an organization has followed established procedures and enables regulatory agencies to conduct inspections.
Quality control is verified based on raw material testing, real-time in-process controls, finished product testing, stability testing, and environmental monitoring. Facilities and equipment used to manufacture products must be designed, constructed, maintained, and validated so that a consistent product is produced. This includes the qualification, calibration and implementation of preventive maintenance plans for all equipment used to manufacture products.
Compliance with regulatory standards entails adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and related guidelines. Internal and external audits will be performed frequently to ensure that manufacturers are compliant. Furthermore, manufacturers will need to be ready for surprise audits from the applicable regulatory body.
The Corrective Action/Preventive Action (CAPA) system will allow for the quick and thorough resolution of quality issues. Implemented procedures address the occurrence of quality issues, identifying the root-cause and taking steps to eliminate them and/or prevent future occurrences. Validation procedures, including those for processes, cleaning, and analytical methods, will ensure that both the manufacturing process and quality control processes are consistent, reliable, and repeatable.
