| PEER-REVIEWED RESEARCH |

Understanding Internal Release Limits

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
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| MANUFACTURING |

Optimizing Containment in OSD Manufacturing

Engineering controls and safe practices protect both operator and product in tablet and capsule production.
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| IMPROVING FREEZE DRYING |

Using Nondestructive in-situ Measurements to Ensure Lyophilized Product Stability

Non-destructive surface area measurement can improve stability testing.
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| QUALITY/REGULATIONS |

US FDA Clarifies Worldwide Inspection Policies

The US Food and Drug Administration is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
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| ANALYTICS |

Lot Release Testing Analytics for Small-Molecule Drugs

Experts discuss up-to-date analytical procedures for the lot release testing of small-molecule drugs.
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| PACKAGING |

Protecting Solid-Dose Shelf Life

Barrier materials, scavengers, and good seal integrity maximize shelf life of oral solid-dosage drug packaging.
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| SUPPLY CHAIN SECURITY |

Sartan Recalls Beg the Question: Is Compendial Impurity Testing Enough?

Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.
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| OUTSOURCING DEVELOPMENT |

Outsourcing Development: Small-Scale to Commercial

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.
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| EUROPEAN REGULATORY WATCH |

Curbing Drug Shortages in Europe

A European task force outlines its upcoming efforts to combat drug shortages.
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| STATISTICAL SOLUTIONS |

Process Stability, Performance, and Capability; What is the Difference?

This article applies the basics of stability, performance, and capability to modern process performance and capability indices.
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| ASK THE EXPERT |

The Link Between Data Integrity and Quality Culture

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
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