Cast Your Vote for the 2016 Article of the Year Award!
The Roger F. Sherwood Article of the Year Award recognizes the knowledge and hard work of the authors that contribute to Pharmaceutical Engineering® magazine. This year, we’re changing it up and letting readers decide which article receives this top honor.
A panel of judges was assembled, comprising two Board members, the Knowledge Network Council Chair, Pharmaceutical Engineering Committee (PEC) Chair, Guidance Documents Committee Chair, one PEC member, two Young Professionals, and two senior ISPE staff members. After reviewing all articles published in 2016, the judges chose the articles below as finalists.
Read each of these notable articles and cast your vote below! Voting will be open 12 December 2016 – 20 January 2017. The winner of the 2016 Article of the Year Award will be announced Thursday, 2 February 2017.
Biopharmaceutical Manufacturing Process Validation and Quality Risk Management
Manufacturing processes for biopharmaceuticals must be designed to produce products that have consistent quality attributes. This entails removing impurities and contaminants that include endotoxins, viruses, cell membranes, nucleic acids, proteins, culture media components, process chemicals, and ligands leached from chromatography media, as well as product modifications, aggregates, and inactive forms. Read Full Article >>
Balancing Pre- and Post-Market Control of Health Supplements
Regulatory authorities (RAs) worldwide employ different terminologies to describe various medicinal and health products. According to the definition by the Association of Southeast Asian Nations (ASEAN), Health supplements (HS) are products used to supplement a diet as well as to maintain and improve the healthy function of human body. Read Full Article >>
Cleaning Buffer Preparation Tank Air–Liquid Interface Rings
Buffers are routinely used in biopharmaceutical manufacturing operations to adjust pH, salinity, or nutrient levels; equilibrate and flush columns and filter membranes; and for in-process and final product formulations. While buffers are easily cleaned with water (with a few exceptions due to high water solubility), the industry continues to struggle with visible residue at the air–liquid interface on buffer preparation and storage tanks. Read Full Article >>
Quality Risk Management for Legacy Products in CMOs
Contract manufacturing organizations (CMOs) operate under the same regulatory expectations as innovators and generic manufacturers, and provide manufacturing capabilities such as formulation, filling or packaging for both groups. They are considered an extension of the company contracting them for the manufacture of drug products. Read Full Article >>
Current Challenges in Implementing Quality Risk Management
Since quality risk management (QRM) was formally introduced to the pharmaceutical industry in 2005 with the publication of the International Conference on Harmonisation (ICH) Q9 guideline on quality risk management, pharmaceutical firms have adopted and implemented its concepts, tools, and methods in different ways and at different rates. Read Full Article >>