Raw Material Supply: Many Issues to Manage

By: Govindra Singh, 2016

Whether producing biologic or small-molecule drugs, pharmaceutical
manufacturers (sponsors and contract service organizations) must manage a
complex network of raw material suppliers, which provide chemical and biological
materials; including starting compounds, intermediates, solvents, cell lines, yeast,
bacteria, cell-culture media and feeds, excipients, production materials such as
tubing, single-use manufacturing equipment and packaging materials, among
others. Ensuring that the correct materials have been received and that they meet
quality and other specifications (such as manufacture under GMP conditions) can
be a daunting task. Extensive collaboration with preferred suppliers and reliance
on third-party vendors that can handle some of the workload are two strategies
that can help simplify the issue and reduce supply chain risk.