Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process ...

Part Two of our Protecting Complete Chain of Custody Series As we discussed in our last post, the Role of Biobanking in Protecting Sample Chain of Custody, biobanks serve as biospecimen libraries as ...

To qualify and validate a pharmaceutical manufacturing facility, one must carefully review the facility design for compliance with good manufacturing practices and manage project scope definition, ...

Expectations of regulators, sponsors, and investors are met through efficient and well-designed quality systems and the implementation of a suitable development-stage. Several firms have unique ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Quality is a difficulty term to define, but most people know it when they see it. A quality product is made well, with integrity and attention to detail. A quality management system (QMS) is a formal, ...

Firms that perform audits, reviews, or compilations have a little more than four months to implement the new risk-based quality management (QM) standards. The task may feel daunting, but Joe Lynch, ...

The adoption of a quality management system (QMS) should be a strategic decision of a Nuclear Medicine service. Its design and implementation will be influenced by various factors, for example the ...