Qualifying Personnel to Visually Inspect Cleaned Equipment
Different approaches for qualification of personnel for visual inspection of residues on equipment surfaces are reviewed.

Interactive Response Technologies for IP Temperature Excursions
Kurt Lumden, Director, Client services at PAREXEL's Perceptive Informatics, discusses the management of investigational product temperature excursions.

Q&A with Roger Hayes, MPI Research
Roger Hayes of MPI Research discusses highly potent drugs.

New Guidances, Investigations to Shape Drug Manufacturing, Regulation in 2014
The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

Mylan Launches First Trastuzumab Biosimilar in India
Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.

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FDA Commissioner to Meet with Indian Regulatory Authorities
In first official visit to India, FDA commissioner to discuss ongoing collaboration on drug programs.

European Medicines Agency Updates Seasonal Flu Vaccine Guidance
EMA releases an update on its flu vaccine guidance.

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NIH, Biopharmaceutical Companies, Non-profits Work to Speed Validation of Disease Targets
NIH, 10 biopharmaceutical companies, and several nonprofit organizations form a partnership to develop new treatments earlier for Alzheimer's, type 2 diabetes, and autoimmune disorders.

EMA Clarifies New Variation Classification Categories
EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

JOT Automation and Tensor ID Work on Syringe Inspection Platform
The companies will pre-promote their auto-injection syringe-inspection platform at ATX West.

NSF International Acquires Auditing Arm of IPEC-Americas
NSF-IPEA now can provide excipient auditing and certification.

BioOutsource to Open New Biosimilar Center of Excellence
BioOutsource will open a new Biosimilar Center of Excellence in Scotland.

Shimadzu Opens New Solution Center in Maryland
Shimadzu’s new Solution Center features additional research space.

Cytovance Biologics Expands GMP Warehouse and Manufacturing Operations
Cytovance Biologics continues to work on the expansion of a manufacturing operations and GMP warehousing facility in Oklahoma.