Glossary

Out of Specification (OOS)

February 27, 2012

OOS results include those that fall outside the specifications or acceptance criteria established in New Drug Applications (NDAs), official compendia, or by the manufacturer.
blog comments powered by Disqus
  • Patent Law  and Contract Manufacturing

    Patent Law and Contract Manufacturing

    Beverly W. Lubit, Member of the Firm, Chiesa Shahinian & Giantomasi||September 8, 2016
    Analyzing the impact of The Medicines Co. vs. Hospira Inc. decision

  • The Impact of Sample Handling  and Processing on the Outcome of Bioanalytical Testing

    The Impact of Sample Handling and Processing on the Outcome of Bioanalytical Testing

    Haiko Pillu, Head Technical Operations, Life Science Services, SGS Belgium NV||September 8, 2016
    Optimizing bioanalytical procedures to get reliable results in clinical studies

  • Quality Risk Management

    Quality Risk Management

    Cheryl Abernathy and Bryan Sasbon, Quality Assurance Operations Manager, Ropack Pharma Solutions; QA Director & Regulatory Affairs, Ropack Pharma Solutions||September 8, 2016
    Embracing the process as a means to a strong quality culture