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| EU GMP Annex 1 continuous viable monitoring solution | The MiniCapt® Mobile Active Air Sampler is ISO 14698:2003 and Annex 1 and compliant for continuous microbial monitoring. IQ/OQ documentation available. Unique impaction pattern allows for false positive identification. Antibacterial housing reduces cross-contamination from monitoring activities. Learn more. |
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| Accelerate Your R&D And QC With These 3 Key Analysis Methods | Article | By Monika Schennen, Julienne Regele, Calliste Scholl, and Morgan Ulrich, TA Instruments | Learn about three key thermal analysis methods for fast and effective characterization and quality control: differential scanning calorimetry, thermogravimetric analysis, and sorption analysis. |
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| Annex 1 Compliance Guidelines For Biological Indicator Users | Article | By Crystal Hostler, Mesa Laboratories | Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators. |
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| Method Transfer – When, Why, How? | Article | By Tammy Thompson-Madsen, Singota Solutions | A formal method transfer is an exercise that demonstrates and documents that a method has been successfully qualified in another laboratory to provide accurate and repeatable results. |
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| Common Challenges And Solutions Of Equipment Ownership And Use | Article | By Matt Hicks, Federal Equipment Company | There are many factors to consider when tasked with acquiring the equipment needed to run a pharma facility. Being aware of every upfront cost is a must when determining optimal equipment ownership. |
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| Revolutionizing Pharmaceutical Quality Control | Case Study | Waters Corporation, Informatics & Software Division | Learn about a South Korean pharmaceutical company's QC laboratory and how the operation of its chromatography systems has been transformed by implementing a real-time monitoring system. |
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| The Value Of Agile Project Management In Pharma's Race To Market | Article | By Andrea Oro and Rui Teixeira, Uquifa S.A.U. | As regulatory policies for drug development tighten and competition intensifies, manufacturers must adopt organizational strategies that enhance flexibility, enabling them to keep pace in today's market. |
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By Tim Sandle, Ph.D. | In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024. |
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