| FACILITY MODERNIZATION |

GMP Facility Modernization: Opportunities for Successful Implementation

The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.
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| TRACK AND TRACE |

Serialization Hits the Home Stretch

As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.
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Testing GS1’s EPCIS Standards in the Real World

Johnson & Johnson Supply Chain (JJSC) and the distributor AmerisourceBergen launched a four-week pilot program to test GS1’s EPCIS standards and to see how effectively data could be transferred between the two partners.
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Speed Bumps on the Road

The author discusses the results from TraceLink and Actionable Research's Global Drug Supply, Safety and Traceability Report.
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| PEER-REVIEWED |

An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress Conditions

This study investigated the stability of solid lactose stored under high temperature and humidity conditions.
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| REGULATORY WATCH |

Moving Forward with Adaptive Licensing

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.
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| OUTSOURCING REVIEW |

Will Pharma Manufacturing Move Back to the US?

Moving global manufacturing operations may be more complicated than it appears.
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| API SYNTHESIS & MANUFACTURING |

Oral Delivery of Biologic APIs: The Challenge Continues

Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.
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| TROUBLESHOOTING |

Understanding Containment

The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.
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| ASK THE EXPERT |

Covering Global Regulations in a Quality System

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.
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| FEATURES |

Insourcing vs Outsourcing: Choosing the Right Strategy

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.
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Key Considerations in Outsourced “On-Site” Audits as Part of Supplier Qualification

This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.
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Collaborating for Efficiency and Safety in Raw Material Inspection

By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.
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Quality Agreements: Managing Global Relationships

A robust quality agreement and good communication scheme can help avoid and alleviate regulatory concerns.
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Serialization: The Final Countdown

Many pharmaceutical manufacturers were late in involving contract partners in serialization efforts. Are you ready, and are you working with the right partner?
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The Challenge of IDMP Compliance

Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.
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