An additional reference was added to the standard which requires reballoting. This refernce is to another ASTM Standard entitled Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute and is standard number E2656. It occurs twice in the document section 2.1 where it is listed amoung the references and section 4.4 in the Significance and Use session.
Keywordsat-line; in-line; in-process measurements; method development; method verification; multivariate modeling; off-line; on-line; particle characterization; PAT; process analytical; process analytical technology; process analytics; process analyzers; qualification; risk assessment; sampling; validation; vibrational spectroscopy;
Ballot Item Approved as E2898-2014 and Pending Publication