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In my role, I've had the opportunity to review many research reports and white papers. However, I felt compelled to share this recently released report by LogiPharma that offers game-changing insight from experts across the pharmaceutical industry who are directly involved with supply chain management. They have come together to provide their advice on how to overcome the challenges presented by an ever-changing supply chain landscape, in order to ensure drugs are delivered safely to the patients who depend on them. Click here to read what companies such as Pfizer, Novartis, Merck, and GSK are doing to achieve supply chain excellence.
By Gary M. Hutchinson, President, Modality Solutions
This paper presents highlights from a thermal performance study conducted by Modality Solutions LLC. The study examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value refrigerated specialty medicines against an industry-accepted temperature profile standard.
By Dr. Rüdiger Lomb, Global Director, Quality & Technical Compliance, World Courier
This article covers improving compliance and efficiency in the pharmaceutical supply chain with reduced cost and risk. How does the sponsor ensure that product transfer conforms to the same established written procedures demanded at the investigator level throughout the full length of the supply chain, or more specifically, while in the hands of nonpharmaceutical, non-investigator personnel?
By Jack Chopper, Chief Electrical Engineer, Filamatic, LLC
I have worked for an equipment OEM for more than 20 years, and I have become a staunch proponent of networking the manufacturing environment such that we realize maximum efficiency from the same. That is not to say that I am unaware of the security implications of doing so. Rather, I believe the gains far outweigh the risks when such networking is done properly and securely. I especially like the model where the individual control systems collect and forward data to a “disinterested,” i.e., uninvolved central server for storage. The data storage usually includes some form of a relational database allowing that nonmanufacturing system to sort, parse, analyze, present, and finalize for release.
By Chuck Reed, B.Sc/MS Director, Weiler Engineering, Inc.
Blow-fill-seal (BFS) product usage has been widely established in the ophthalmic and respiratory therapy markets for some time, and lately BFS technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.
By Chuck Reed, Weiler Engineering, Inc.
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.
By Tara S. Hundley, Anton Paar USA
What drives a pharmaceutical company to scrutinize an instrument manufacturer and every detail of the instrument during instrument qualification? The answer is simple, compliance to regulations. Every company that produces pharmaceutical products must guarantee consistent quality that meets regulated specifications — for the entire product life cycle, from production to consumption.
By Dipl.-Ing. Sebastian Kundel, Product Manager Process and Control Valves, Bürkert Fluid Control Systems
In the food and beverage industry, and also in the production of medicines and cosmetics, excellent hygiene in processes and around the plant plays a key role. This is ensured by stringent legislative regulations. Standards such as HACCP (hazard analysis and critical control points) for food processing and gMP (good manufacturing practice) for FDA-compliant processes in the pharmaceutical industry define extremely stringent requirements for cleanliness, safety, and product quality.
By Paul Daniel and Jon Aldous, Vaisala
The FDA mandates the validation of environmental conditions that can affect the strength, identity, safety, quality, and purity of pharmaceuticals, medical devices, or biologics. To meet these requirements for temperature or humidity we perform a mapping validation, usually as part of an installation qualification and operational qualification of the environment, be it: incubator, fridge/freezer, stability chamber, cold room, or warehouse.
By Robert McGregor, Brookfield Engineering Laboratories, Inc.
How do you bring consistency to QC testing? Pharmaceutical products that meet manufacturability criteria and provide high-level consumer satisfaction undergo a battery of tests before being distributed to the consumer. Using affordable instrumentation to perform QC tests that certify that tablets, capsules, elixirs, ointments, etc. have the right physical properties is essential for today’s successful business.