Quality by Design

Process analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

Regulators and industry seek to streamline and harmonize oversight of postapproval changes.

PAT holds the key to real-time quality assurance and consistent product quality in pharmaceutical manufacturing.

Will biosimilars share a compendial identity like generic drugs do?

The directorate highlights achievements accomplished during the year of its 50th anniversary.

While biotech will revolutionize our industry through new products and new reaction pathways, process analytics is the link between process automation and the laboratory sector, and water plays a key role as a valuable resource all over the world.

The basic principle behind QbD is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.

Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.

QbD represents a breakthrough in thinking, but does it go far enough to address today's business challenges? NeoStem has expanded it to include business and market issues, in "Development by Design." Could this be (or is it becoming) a new model for pharma?

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

The pharmaceutical supply chain continues to be a challenge for the industry despite advances in QbD and PAT.

CPhI experts make predictions on pharma trends for 2015.

Experts review considerations for selecting excipients for solid-dosage drug performance and manufacturability.

FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.

Analytical procedures and method validation should be developed with a structured and rigorous approach.

The parenteral manufacturing industry is taking action to address particulate contamination issues.

Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.

With a quality-by-design approach, robust processes can help deliver quality product consistently.

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

With a quality-by-design approach, robust processes consistently can help deliver quality product.

Quality by design, process analytical technology, and high throughput screening have helped drive progress in pharmaceutical development.

Quality by Design has initiated a paradigm shift in solid dose pharmaceutical manufacturing.

Contract service providers describe how quality by design has influenced a drug sponsor's expectations of suppliers.

Regulators and industry organizations explain policies and standards to manufacturers and authorities across the globe.

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.