| API SYNTHESIS AND MANUFACTURING |

Consistent API Quality Calls for Collaboration

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.
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| PEER-REVIEWED RESEARCH |

Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
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| DATA INTEGRITY |

Integrated Systems Aid Data Integrity

Integrated computerized systems for data collection improve data security and offer a solution for handling temporary data.
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| ANALYTICS |

The Statistical Evaluation of Cleaning Processes Using Process Capability and its Application to New Product Introduction

The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.
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| PACKAGING |

Improving Visual Inspection

Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.
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| SUPPLY CHAIN |

Best Practices for Shipping Single-Use Systems

Shipping biopharmaceuticals in single-use containers requires a thorough understanding of the distribution cycle and potential transportation risks.
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| STATISTICAL SOLUTIONS |

Reportable Values: Where is the Variation Coming From?

This article looks at a simple structured approach to assigning variance contributions and to assuring that the analytical procedure is fit for purpose.
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| FROM THE EDITOR |

Key Ingredients to Healthcare's Future

A skilled workforce is needed to deliver on technology's promising medical advances.
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| OUTSOURCING OUTLOOK |

CDMOs Driving Emerging Bio/Pharma Success

CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
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| US REGULATORY WATCH |

Gottlieb Tackles Tough Issues in First Year at FDA

FDA's commissioner addresses opioid abuse, drug costs, and manufacturing quality.
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| ASK THE EXPERT |

Harmonization of Batch Records

Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
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