Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel. Q. We are planning to market a new drug (film coated ...

Although some aspects of process validation for continuous processes are the same as those for traditional batch processes, there are some unique considerations. Although some aspects of process ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

Companies choose manufacturing processes -- such as job order, batch process, assembly line and continuous process -- based in part on the level of product individualization allowed. Manufacturers use ...

TYSONS CORNER, VA, June 29, 2017 ” Another batch of Iridium Communications (Nasdaq: IRDM) satellites has been launched Sunday to join a growing constellation that will work to provide L-band satellite ...

Batch processing, or batch production, is a scaled-down version of assembly line production. Products are produced in groups instead of in continuous streams as they are on assembly lines. However, ...