New Japanese Pharmacopoeia(JP16) Regulations Impact TOC Monitoring

August 13, 2012 - Boulder, CO - On April 1, 2011, the Japanese Pharmacopeia (JP) published changes in the JP 16 monograph that described new analytical testing requirements for Purified Water (PW) and Water for Injection (WFI). These changes will directly affect the validation of new and existing Total Organic Carbon (TOC) analyzers used for either laboratory or on-line TOC analysis.

The deadline for complying with these new Japanese Pharmacopoeia (JP16) requirements is September 30, 2012.

JP 16 Impact on Total Organic Carbon (TOC) Analyzer Validation

GE Analytical Instruments has carefully analyzed the JP16 changes, and developed several documents to help you find out if your TOC instruments are compliant:

Learn More About JP 16 Compliance

Non-compliance can result in product shipment delays, investigations and negative publicity. Contact us for additional information on this new regulation and how you can comply.

Japanese Pharmacopoeai (JP16)