Quality Control/Quality Assurance

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

New program emphasizes quality, risk, and global collaboration.

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.

USP responds to FDA's draft guidance on the naming of biological products.

The PDA report discusses qualification and operational handling of passive thermal protection systems.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

US Compounding, Inc. issues voluntary recall of all sterile products.

Manufacturers challenge details in new policies designed to promote access to important therapies.

The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

The rapid microbiological growth-based method represents an alternative for the quantification of contaminants in filterable products.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

FDA issues guidance regarding fees for drug compounding outsourcing facilities.

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

FDA warns an Arkansas compounding company that it is in violation of the FDCA.

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

The agency streamlines risk and mitigation information.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

Will biosimilars share a compendial identity like generic drugs do?

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

Industry and regulatory agencies continue to make progress in establishing quality metrics for the pharmaceutical industry.