Facing ongoing challenges with drug shortages and quality problems, the pharmaceutical industry seeks robust solutions. FDA’s Quality Management Maturity (QMM) initiative offers a promising pathway. By focusing on four key pillars, including sustainability, risk management, regulatory compliance, and quality culture, the QMM initiative aims to elevate the entire manufacturing chain’s reliability and quality. Embracing these… Continue reading QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract Manufacturers
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Indian Government sets deadline for Pharma GMP Compliance
<![if !vml]> <![endif]> Home U.S.-based consulting firm providing compliance and remediation expertise in scientific, technical, regulatory affairs, and management to public and private sector organizations. August 7, 2023 Indian Govt sets deadline for Pharma GMP Compliance Adopt WHO-standard good manufacturing practices (GMP) within One Year The Indian government has set a deadline for mandatory implementation… Continue reading Indian Government sets deadline for Pharma GMP Compliance
Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence
In recent months, FDA has begun championing Quality Management Maturity (QMM), a new quality surveillance initiative intended to raise awareness at all levels of management in the pharmaceutical industry as to how to best achieve quality objectives and improve manufacturing site quality and supply chain reliability in drug manufacturing processes. QMM follows a maturity modeling paradigm first developed and adopted by other high technology industries. The nexus between a clearly articulated mature quality culture, technical processes, and corporate-wide business practices that are integrated with quality objectives has crystallized into a viable roadmap for enhancing a drug manufacturer’s operations, while satisfying patient needs and corporate goals.
FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations
FDA mentioned QMM in its 2019 report, Drug Shortages: Root Causes and Potential Solutions, which pointed to a lack of manufacturer incentives to improve their quality management beyond the minimum required for current good manufacturing practice (CGMP) compliance. In this podcast learn what QMM is, and how far beyond GMP functions QMM will drill into, and what accountability senior management bears for sustaining a corporate quality management culture, from an interview with executives at Shabas Solutions LLC, who ran the overseas pilot program.
