By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.
By Steve Watson, Sartorius Intec
Smart calibration; or the ability to commission tank load cells without test weights or flow meters, can significantly reduce the installation cost and improve overall weighing accuracy.
By Kevin Zarnick, Thermo Fisher Scientific
Using metal detection as a means of identifying foreign object contamination has been prevalent in the food industry for decades. Although metal detection has also been in use to identify the presence of ferrous, nonferrous, or stainless-steel contaminants during the past 40 years in the pharmaceutical industry, it has not been widespread.
By Yvonne Yeo, Bioquell Inc.
RBDS (room biodecontamination service) is not only about the practical side of service delivery. We understand that it is important for our customer to hold detailed records of what actions were performed on their site, ready for regulatory or audit inspections, including batch and serial numbers, equipment locations, biological indicator locations, and results. This, of course, is on top of the risk assessment, method statement, contract briefing note, scope of works, and other cycle optimization documentation.
By Jim Tennermann, Vaisala, Inc.
Everyone in the quality profession has heard the term "NIST traceable." Having calibration traceability to the National Institute of Standards and Technology (NIST) is desirable for most measurement devices. It is also enshrined as a requirement in some regulatory documents. Unfortunately, NIST traceability does not ensure measurement quality.
By Margit Gieseler, GILYOS GMBH; and Henning Gieseler, University Of Erlangen
This technical note provides an overview of freeze drying from small container systems, with a focus on the Virtis Freeze Drying System (FDS). Lyophilization from small container systems, e.g., 96-well PCR plates, is particularly attractive for highly potent APIs such as peptides or cytostatic agents. Other interesting applications include high-throughput screening and long-time storage of minimal amounts of samples sensitive to heat and moisture.
By Ryan Mauro, Validations Sales Specialist, Sartorius Stedim Biotech
Process validation is the collection and evaluation of data throughout the manufacturing process, which establishes, scientifically, that there is consistency of quality, reproducibility, and traceability from batch to batch.
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