Quality by Design

QbD paradigm advances process understanding in development and manufacturing.

Factors for assessing excipient variability, the associated challenges developers need to address to design and manufacture solid oral drug products, and solutions for such challenges are examined.

The use of various documents and guides by the International Pharmaceutical Excipients Council can facilitate the flow of information among excipient manufacturers, distributors, and users.

Can postapproval FDA filings immunize pharma companies from patent lawsuits?

The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.

Managing risk in biopharmaceutical operations is of utmost importance for patient protection.

The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.

This study examines the effect and interaction of variations in hypromellose physicochemical properties.

Working together affords many unseen opportunities for pharmaceutical innovation.

Bristol-Myers Squibb has initiated a voluntary recall of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company, to the user level.

PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.

MIT survey results address product and site characteristics that statistically correlate with quality performance.

The author discusses strategies for preventing cargo theft.

The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.

ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

Readers point to quality by design as having a significant influence on manufacturing and drug development during the past decade.

An industry roundtable on how users and makers can best assess and manage black specks.

Readers share their views on bioprocessing challenges, equipment use, and outsourcing trends in our annual bioprocessing equipment and processing survey.

A Q&A with Chris Meissner, president of Meissner Filtration Products, on recent industry trends.

The article examines some recent developments for this process step and for continuous manufacturing overall.

FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.

ICH Q8, Q9, and Q10 support and implications for the future.

A Q&A with Gilles Cottier, president of SAFC, on recent industry trends.

The authors describe the operational qualification of test accuracy with regard to temperature drift using a thermal-compensation algorithm on several freeze dryers.

June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.

Recent recalls have contributed to the pharmaceutical industry?s heightened awareness of glass delamination (i.e., the formation of glass flakes in a vial), which could affect drug quality and patient safety. To confront this growing problem effectively, drugmakers must understand its causes.

Despite new hurdles, industry must move forward and fulfill its mission.

A report commissioned by FDA evaluates the QbD program.

Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.