Essential Insights Into Pharmaceutical Product Release: Part 2

Pharmaceutical product release is a complex process requiring effective planning, communication, and quality management. Early consideration of release specifications during development helps prevent delays and costly deviations. By defining clear release criteria and leveraging robust process characterization, companies can optimize efficiency and ensure compliance.
Electronic systems, such as electronic quality management systems (eQMS) and electronic batch records (EBR), streamline operations by integrating data from multiple sources. These tools provide real-time insights into training records, supplier qualifications, and corrective actions, enabling efficient quality control and faster batch release.
Collaboration with contract manufacturing organizations (CMOs) can enhance production efficiency, but ultimate responsibility for product release lies with the manufacturer. Formal agreements, clear roles, and timelines ensure seamless coordination between CMOs and license holders. Third-party quality consultants may further support the release process by offering specialized expertise in record review and compliance management.
Adopting a systematic approach that integrates advanced digital tools, process optimization, and effective partnerships allows pharmaceutical companies to ensure consistent product quality, maintain regulatory compliance, and accelerate time to market.
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