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    MHRA Cites Pharmaceutics International for GMP Issues at Two US Sites

    The Medicines and Health Care products Regulatory Agency (MHRA) on Wednesday cited US-based contract manufacturing organization Pharmaceutics International, Inc. (Pii) for critical deficiencies at two of its Maryland facilities. In the reports, outlined in two separate statements of non-compliance published to the European Medicine Agency's (EMA) EurdraGMP database, the inspectors say they identified a "failure of organizational and technical measures to minimize the ris...
  • EMA Announces Planned Office, Website Closings Starting 5 April

    Regulatory professionals hoping to do business with the European Medicines Agency (EMA) between 5-9 April or access any of EMA's online offerings on 5 April will be out of luck, the agency announced. The agency plans to temporarily close its doors between 6:30 PM London time on 4 April, and remain closed until 7:30 AM local time on 10 April 2012. EMA notes its emergency line at +44 (0)20 7523 7600 will still be operational in the event of an emergency involving a "seriou...