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 ...

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This ...

Overview: This course provides regulatory/quality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation ...

The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

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 ...

Quality and reliability are essential in pharmaceutical manufacturing. To ensure compliance and high standards are consistently met, the Installation Qualification (IQ), Operational Qualification (OQ) ...