Regulatory/GMP Compliance

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.

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.

FDA and EMA release a draft joint proposal on the development of new drugs to treat Gaucher disease in children.

USP releases new and revised standards for organic impurities in medicines for public comment.

USP evaluates raw materials used in the chemical synthesis of peptides.

Agencies extend successful pilot program to further harmonization of QbD topics.

USP evaluates quality attributes for synthetic peptides.

Design of experiment is a powerful development tool for method characterization and method validation.

FDA provides recommendations for submitting analytical procedures and methods validation data.

FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

NIH, 10 biopharmaceutical companies, and several nonprofit organizations form a partnership to develop new treatments earlier for Alzheimer's, type 2 diabetes, and autoimmune disorders.