Quality/GMPs

An advisory committee recommends use of the first psoriasis therapy targeting IL-17A.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Pfizer's addition of a new vaccine suite and multiproduct bioprocess suite to its Ireland facility win the company the title of 2014 Facility of the Year.

Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.

The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.

Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

The authors discuss complications of implementing continued process verification and provide recommended approaches.

Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.

Unexpected problems can become opportunities to share knowledge and improve processes.

A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.

Demand for new therapies and vaccines spotlights production challenges.

FDA report details risk mitigation projects.

USP expresses its support for a consensus-based global approach to the naming of biologics.

GS1 publishes a healthcare industry guideline describing how to implement GS1 standards to support requirements of the 2013 US Drug Supply Chain Security Act.

GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

FDA releases draft guidance on electronic submission of lot distribution reports.

This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.

Chinese healthcare reforms may be a double-edged sword for foreign companies.

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

FDA demands accurate manufacturing and test information to ensure product quality.

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.

Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.