Drugmakers still confused by CFR-21 parts 210 and 211, says West

By Gareth Macdonald

- Last updated on GMT

Since coming into effect late last year, US Code of Federal Regulations-21 parts 210 and 211 testing rules have been the subject of much confusion in the pharmaceutical industry, according to West Pharmaceutical Services.

At Interphex 2009 in New York,US Outsourcing-pharma spoke with industry expert Jennifer Riter of West Pharmaceutical Services about the scope of the CFR-21 parts 210 and 211 as they apply to microbiology, de-pyrogenation processing and batch closure regulations.

Riter also talked about how well the pharmaceutical industry has adapted to the new good manufacturing practice (GMP) standards and explained how West can help its customers understand and comply with the rules with its line of ready-to-steralise components.

Related topics: Processing equipment, QA/QC

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