| CLEANING VALIDATION AND MONITORING |

Evaluating Surface Cleanliness Using a Risk-Based Approach

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
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| PEER-REVIEWED RESEARCH |

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.
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| TRANSDERMAL PATCH MANUFACTURING |

Critical Parameters in Transdermal Patch Manufacturing

A QbD approach can address manufacturing complexities in transdermal patch manufacturing.
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| LYOPHILIZATION |

Modernizing Lyophilization

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.
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| FACILITY DESIGN AND OPERATION |

Designing Sustainable Pharma Facilities

Optimizing water and HVAC systems can reduce resource use in all pharma facilities, and, for biopharma manufacturing, the supply chain of consumables should be evaluated.
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| GOOD DISTRIBUTION PRACTICES |

Reliability Rooms and the Move to Proactive Supply Chain Management

Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
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| REGULATORY WATCH |

Transformative Medicines Challenge FDA and Manufacturers

New gene therapies and combination products require innovative regulatory approaches.
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| OUTSOURCING OUTLOOK |

Pharma Outsourcing: A Year in Review

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.
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| ASK THE EXPERT |

What's in Your SOP?

SOPs need to reflect a company's specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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| FROM THE EDITOR |

Wanted: A Highly Skilled Bio/Pharma Workforce

Is pharma up to the task of developing knowledgeable, motivated employees?
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