Prashant Upadhyay
Stories (3/0)
Advancing Pharmaceutical Quality Assurance: Synergy of Real-Time Release Testing, Continued Process Validation and Annual Product Quality Review
Guaranteeing safety, efficacy, and quality of drugs stands as utmost priority in the realm of pharmaceuticals. Historically, achieving this has leaned heavily on batch testing, where samples from each production batch undergo rigorous scrutiny before release. Yet, this method faces constraints, such as delays in product availability and the inability to detect certain deviations until after production. To tackle these hurdles, the concept of real-time release testing (RTRT) has emerged, offering the promise of more prompt and effective release of pharmaceutical products. At the core of RTRT lies continued process validation (CPV), facilitating ongoing assessment and assurance of product quality throughout the manufacturing process. Additionally, Annual Product Quality Review (APQR) plays a pivotal role in providing comprehensive evaluation of product quality over time, complementing CPV and RTRT endeavours.
By Prashant Upadhyay9 days ago in Futurism
Enhancing Product Quality Review through Automated Excursion Handling in Pharmaceutical Manufacturing
Effective excursion handling is vital in pharmaceutical manufacturing to maintain product quality and regulatory compliance. Integrating technological solutions into Product Quality Review (PQR) workflows offers a comprehensive approach to address deviations promptly and efficiently. By automating excursion handling processes within the PQR framework, pharmaceutical companies can ensure timely resolution of issues, enhance product quality, and streamline regulatory compliance.
By Prashant Upadhyay15 days ago in Futurism
Risk-Based Approaches to Annual Product Quality Review (APQR) SOP Development
Product quality assurance is primal in pharmaceutical manufacturing. With regulations evolving and the complexity of products increasing, it’s essential for companies to implement robust quality assurance processes. One such critical process is the Annual Product Quality Review (APQR), which plays a pivotal role in evaluating and monitoring product quality throughout its lifecycle. However, developing Standard Operating Procedures (SOPs) for APQR requires careful consideration, particularly in identifying and prioritizing critical quality attributes (CQAs). This article explores the importance of risk-based approaches in APQR SOP development to ensure a focused assessment on CQAs.
By Prashant Upadhyay15 days ago in Futurism