Regulatory/GMP Compliance

The company voluntarily recalls product due to FDA observations of potential sterility problems.

The agency cites Apotex’s Bangalore facility with quality system failures.

The agency releases five draft guidance documents related to drug compounding and repackaging.

FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.

The National Institute for Health and Care Excellence released an updated version of its biosimilar approach guidance, including increased consideration for technology appraisal, references in documentation, and the production of “evidence summaries”.

President Obama unveils his “Precision Medicine Initiative”.

FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.

FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

The FDA center released a list of the guidance documents it plans to publish in 2015.

Switching grades of raw material late in the development cycle can be costly. Best practice says get it right at the beginning.

Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

The author presents opportunities and challenges in implementing the product lifecycle approach.

Performing degradation studies is the best strategy to evaluate toxicity risk.

USP and ChP jointly host two-day meeting to strengthen cooperation.

New publications from BPSA and PDA highlight best practices for particulate control, quality agreements, and implementation strategies.

The agency cites deviations from CGMPs for the manufacture of APIs at the company's Gujarat, India plant.

USP releases compendium of quality standards for compounded medicines.

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

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

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.

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

FDA draft guidances seek to maintain accurate drug information in new media.

Achieving excellence in human performance is an achievable system of cultivating and sustaining exceptional levels of performance.

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

EDQM details the agency?s accomplishments in 2013.