Quality Systems

Jerold Martin was the senior vice president of global scientific affairs at Pall Life Sciences and the chairman of the Board and Technology Committee at Bio-Process Systems Alliance.

Articles

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.

Focus on Standardisation, Quality by Design and Regulatory GMP

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.

Steps for Reducing Glass Delamination

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

Advancing with the Times

Michelle Hoffman, editorial director of Pharmaceutical Technology.

A report commissioned by FDA evaluates the QbD program.

Retrospection and Introspection at FDA

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.

FDA Perspectives: Understanding Challenges to Quality by Design

A summary of the latest steering committee and expert working groups' meeting.

Inside ICH: Quality Implementation and Harmonization Continue

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

International Federation of Pharmaceutical Manufacturers and Associations takes global action to improve public health.

Global Healthcare on the Ground: IFPMA Engages Global Bodies to Push Health Efforts Forward

Industry buy-in is increasing as pharma companies proceed with select projects and research.

Continuous Progress in Continuous Manufacturing

Last week, Ben Venue Laboratories decided to exit the contract-manufacturing business during the next several years, thus ending more than 70 years of service in this field. To ensure the supply of medically necessary products, the company will work with its customers to develop and execute long-term transition plans.

Ben Venue Laboratories Exits Contract Manufacturing Business

We try to use previous experience to develop the optimal granulation process for each new ingredient, but we sometimes get it wrong. Many times, we?ve taken materials from the granulator only to find that they exhibit poor flow and insufficient density. How can we easily determine the end point of a given granulation process?