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Featured Whitepaper: Vaisala
Environmental Mapping: Validation Protocols GxP Webinar
Sponsored By: Vaisala
Join Vaisala’s Senior Regulatory expert Paul Daniel for this 1-hour recorded tutorial on the best practices for creating protocols for environmental validation applications. Learn the rationale and common methods for conducting periodic mapping studies.
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Managing the Complexities of Global Pharmaceutical Sourcing
Sponsored By: DPT Laboratories
With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve. These trends have forced life science industry companies to optimize sourcing activities for raw materials, intermediates, active pharmaceutical ingredients (APIs), and other material components for clinical supplies and commercial manufacturing. Download this white paper to learn more. |
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Anticipating success: Meeting the inherent challenges of complex drug substances
Sponsored By: Vetter Pharma International GmbH
Realizing the full potential of a novel injectable drug compound is no small task. Unexpected scientific and technical challenges can slow development to a halt. Learn more about practical solutions (e.g. sterile process design, stability analysis). |
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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larking
Sponsored By: Kimberly-Clark Professional
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination. |
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Glass Delamination in Pharmaceutical Vials
Authors: Dr. Jeff Shallenberger
Sponsored By: Evans Analytical Group
There have been several recent drug recalls related to the appearance of glass particles in pharmaceutical solutions. In an effort to understand this phenomenon, we present the use of several surface analytical techniques to investigate the effects of pH on glass storage vials and the subsequent delamination of surface layers. |
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Life Sciences Guidebook on Best Practice Compliance Solutions
Author: Tim Lozier
Sponsored By: EtQ Inc.
This paper provides you with a basic overview for selecting, implementing and using FDA Compliance and Quality Management solutions. Learn the importance of QMS, best practices for FDA Compliance and Quality systems, and tips and tricks for finding the solution best suited for your company. |
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Three Steps to USP H2O Success
Author: Geoff Sheffrin
Sponsored By: OBK Technology
USP water systems are highly specific in their requirements. To get there successfully is relatively easy BUT you are dealing with a large number of detailed requirements that MUST work in harmony to produce reliable Purified Water or Water for Injection - cost effectively and with minimum maintenance. Here's how. |
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Education versus Training
Authors: Martin Lush and Neil Wilkinson
Sponsored By: NSF Pharma Biotech
We all know your products are only as good as the people involved in making them. It goes without saying that how you educate your people is vital to your success.. Learn more about the real difference between education and training here. |
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Automated Audit Management Best Practices
Sponsored By: Sparta Systems
In response to recent high-profile product safety issues, the quantity and breadth of internal audits and external audits of suppliers and outsourcing partners have increased significantly. With stepped up audits, inefficient, manual, siloed processes are now causing significant problems, including: poor communications and scheduling; inefficient use of auditor and auditee resources; inconsistent audit output; lack of visibility and oversight into trends; and difficulty in ensuring appropriate follow-up on corrective and preventive actions (CAPAs). All these issues can have an adverse impact on operational effectiveness and product quality. |
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Introduction to cGMP Sampling: The Basics
Sponsored By: IVT NETWORK
This article is an attempt to provide both a general overview of sampling as it applies to pharmaceutical manufacturing, AND a series of specific applications of sampling approaches for various products and activities encountered in the industry. |
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Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin; Feng Zhang, PhD; James C. DiNunzio, PhD
Sponsored By: Leistritz
Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides. |
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Analysis for Polysorbate 80 Using New High Performance Liquid Chromatography (HPLC) Method with Charged Aerosol Detection (CAD)
Author: Lindsay L. McNalley
Sponsored By: Impact Analytical
Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) is a common nonionic surfactant, emulsifier and solubilizer that is used in a wide variety of industries and applications. Polysorbate 80 is typically used in food products, cosmetics, medications, vitamins, and vaccines. There can be many reasons a company may need to determine the exact amount of polysorbates in their material. For example, companies may need to determine AIG limits in their products, validate analytical methods for product production, or require the information for reverse engineering purposes. Thus, a well-developed analytical method is crucial for accurately quantitating polysorbates. |
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Ultra Fast UHPLC Method Scouting
Sponsored By: Shimadzu
The traditional process of investigating analytical conditions during method development is often complicated and time-consuming. This Report introduces the Nexera Method Scouting system, a UHPLC system for identifying and resolving the limiting factors associated with traditional method development techniques. |
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