OR WAIT null SECS
August 02, 2016
A Q&A with FDA to gain insight on FDA's views of three-dimensional printing and its regulation in drug manufacturing.
Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.
Recent revisions to the European Union’s good distribution practices, which were updated in 2013, reflect increased regulatory focus on the supply chain.
Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.
July 08, 2016
The agency says that the routine large-scale compounding of drugs that are exact copies of existing medications undermines the the drug approval process.
July 06, 2016
The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.
FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.
July 02, 2016
Agency guidance and industry standards aim to reduce lapses and improve quality operations.
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.
Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.