Regulatory/GMP Compliance

The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.

The directorate is looking for experts to join the European Pharmacopoeia network.

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.

Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.

The United States Pharmacopeial Convention announced the recipients of the 2015–2016 Global Fellowship Awards.

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

FDA seeks feedback on possible analytical standards and approaches to optimize regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests.

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

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.

The authors discuss performing investigations of biological products.

USP responds to FDA's draft guidance on the naming of biological products.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

The new committee will attempt to recruit regulatory professionals outside of existing ICH members to improve overall global pharmaceutical regulatory harmonization.

The agency gives an update on the regulation of combination medical products.

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

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

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

Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.