Regulatory/GMP Compliance

The biopharma industry has had some successes but still needs to work on operational issues.

Differentiation and Characterization of Protein Aggregates and Oil Droplets in Therapeutic Products

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities-Limits and Elemental Contaminants in Dietary Supplements.

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.

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

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The agency releases five draft guidance documents related to drug compounding and repackaging.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