Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, provides simple answers to frequently asked questions regarding batch records. A.The MBR is the controlling document for ...

Job production is when individual products are made one at a time to meet specific customer preferences. An example would be tailor-made suits, which are made specifically to each customer’s ...

Microspheres are small spherical particles ranging from 1 to 1000 micrometers in size. They are widely used in the pharmaceutical and biotechnology industries for drug delivery, controlled release ...