| EXCIPIENTS AND MANUFACTURING |

Growing Demand for Taste-Masking Technologies

Taste masking increases drug acceptability and medication adherence in pediatric, geriatric, and other special patient populations.
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| ASEPTIC PROCESSING |

A Revised Aseptic Risk Assessment and Mitigation Methodology

The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.
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| DATA INTREGRITY |

Establishing an Effective Data Governance System

Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.
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| PEER-REVIEWED RESEARCH |

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart

In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.
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| RISK ASSESSMENT |

Managing the Cost of Non-Compliance

Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.
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| ANALYTICAL TEST METHODS |

Comparing Endotoxin Detection Methods

Inadequate endotoxin testing places patients at risk. Knowing the relative strengths and weaknesses of available test methods is crucial to maintaining quality and safety.
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| CLINICAL TRIAL LOGISITICS |

Moving Toward Direct-to-Patient Models

Despite GxP and data-management challenges, pharma is moving toward new models for clinical trial logistics.
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| REGULATORY WATCH |

FDA Overhauls Inspection Process and Field Operations

FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
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Europe Leads the Way in Continuous Manufacturing

The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.
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| OUTSOURCING OUTLOOK |

CDMO Acquisitions Build Strategic Supplier Base

Recent acquisitions are creating CDMOs with scale that rivals global bio/pharma.
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| ASK THE EXPERT |

Change Control for Standard Operating Procedures

The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
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| FROM THE EDITOR |

Awards Recognize Industry Contributions

Industry experts were honored for business, scientific, and social contributions.
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