Efficiency and compliance are sometimes presented as competing priorities in pharmaceutical manufacturing. One side wants faster processes, less paperwork and lower costs. The other wants controls, documentation and assurance. That is an increasingly outdated way of looking at quality. A mature Pharmaceutical Quality System should be capable of improving efficiency while protecting patients and
Outsourcing has become an established part of modern pharmaceutical manufacturing. Drug developers may depend on Contract Manufacturing Organisations (CMOs), Contract Development and Manufacturing Organisations (CDMOs), testing laboratories, packaging specialists, logistics providers and raw-material suppliers spread across multiple countries. The advantages are significant. Outsourcing can provide specialist expertise, additional manufacturing capacity, access to advanced technologies
Electronic Quality Management Systems have become central to the way pharmaceutical organisations manage deviations, CAPAs, change controls, audits, training, documentation and other critical quality processes. Yet the more important an eQMS becomes to an organisation, the more complicated upgrading it can become. What may appear to be a straightforward software project can quickly become
