| ANALYTICS: DATA INTEGRITY |

Maintaining Lab Data Integrity

This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.
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| EXCIPIENT QUALITY |

Managing Risk in a Complex Excipient Supply Chain

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.
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| PEER-REVIEWED RESEARCH |

Establishing Correlation Between Aerosol and Surface Microbial Populations

The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
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| SOLID DOSAGE DRUG MANUFACTURING |

Material Traceability in Continuous Pharmaceutical Tablet Manufacturing

A systematic framework and software are needed to implement material traceability in continuous pharmaceutical tablet manufacturing.
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| FACILITY DESIGN AND OPERATIONS |

Designing a Single-Use Biopharmaceutical Process

Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.
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| MATERIALS QUALIFICATION |

New Standards Define Single-Use Materials Qualification

Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.
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| ANTICOUNTERFEITING |

Anticounterfeiting: In Search of the Unhackable

While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.
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| DRUG DEVELOPMENT |

How Particulate Modelling will Revolutionize the UK’s Pharmaceutical Sector

Particulate modelling has the potential to transform productivity within the pharmaceutical manufacturing industry, speeding up production cycles, reducing manufacturing costs, improving efficiency, and driving inward investment, with the potential to reinstate the UK as a global manufacturing powerhouse.
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| EU REGULATORY WATCH |

Barriers to ATMP Drug Development

Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.
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| VIEWPOINT |

Annex 1 Misses the Mark

The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.
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| ASK THE EXPERT |

Applying GMPs in Stages of Development

Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety.
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