| CONTINUOUS MANUFACTURING |

Cleaning Validation in Continuous Manufacturing

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.
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Lubrication in Continuous Tubular Powder Blenders

Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.
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| QA/QC |

Dissolution Testing

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.
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| METHOD DEVELOPMENT |

Application of QbD and QRM to Analytical Method Validation

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.
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| PEER-REVIEWED RESEARCH |

Impact of Quality by Design on Topical Product Excipient Suppliers, Part II: Reasonable Expectations

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.
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| SUPPLY CHAIN |

Managing Risk in Raw Material Sourcing

Vendor selection and materials testing are complex enough, but in today's volatile environment, risk mapping and monitoring are also crucial.
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| REGULATORY WATCH |

Tackling Breaches in Data Integrity

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.
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| API SYNTHESIS & MANUFACTURING |

“Rebirth” of Cocrystals?

FDA redefines cocrystals as APIs and not drug-product intermediates.
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| OUTSOURCING |

Five Themes That Will Drive the CMO Industry

CMO executives are focusing on M&A activity, new business models, and fundraising limits.
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| EDITOR'S COMMENT |

The Cost of Counterfeits

The proliferation of counterfeit medicines is nothing new to pharma; however, the scale of the problem seems to be escalating.
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| ASK THE EXPERT |

The Human Factor in Inspections

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
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| PRODUCT SPOTLIGHT |

Integrated Membrane for Single-Use Filtration Assemblies

Sartorius Stedim Biotech's polyethersulfone membrane is now integrated into two new, sterile Sartocon benchtop and production-scale filtration assemblies.
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Dual-Shaft Mixers Provide Efficient Turnover

Dual-Shaft Mixers from Ross, Charles & Son are suitable for mixing 50-, 100-, and 200-gallon batches.
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Biomolecule Separator Reduces Sample Absorption

Yarra 1.8µm SEC-X300 from Phenomenex is a high-resolution gel filtration chromatography (GFC)/aqueous size-exclusion chromatography (SEC) column for the separation of high molecular weight biomolecules on high-performance liquid chromatography and ultra-high pressure liquid chromatography systems.
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Workstations Allow for Continuous Control of Cell Culture Processes

The InvivO2 workstations range from Baker Ruskinn allow researchers to conduct cell culture processes under a continuously controlled, physiologically relevant atmosphere.
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