iSpeak Blog

August 29, 2017
Participants gathered for the Women in Pharma breakfast on day 2 of the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference, held 5 – 7 June. Women in Pharma Chair, Fran Zipp, CEO and President, Lachman Consultants and ISPE Board member, welcomed the...
August 28, 2017
A deeper understanding of HVAC and environmental control is essential to ensure the quality and purity of a product. HVAC systems are crucial to pharmaceutical manufacturing because they control the manufacturing environment, which can impact the Str...
August 21, 2017
This article was originally published in the July – August 2017 issue of Pharmaceutical Engineering® magazine . Missed part one? Catch up now – Performance and Validation of Ozone Generation for Pharmaceutical Water Systems – Part 1 . Get part three...
August 16, 2017
Technology is not new. Biotechnology is not new; it’s new-ish. Yet when the two come together to look at how they can transform medicine, its creation, delivery, and access, well, that is new and can be extraordinary. Extraordinary enough that the FD...
August 15, 2017
It’s hard to believe that another summer has come to an end, but that also means the 2017 ISPE Process Validation Conference is right around the corner! Our theme is “Outcomes that Matter: Benefits of Implementing the Process Validation Lifecycle”. W...
August 14, 2017
To deliver a consistent and reliable final product, process validation is a crucial concept to understand. The three-stage paradigm covers the entire product lifecycle to manufacture a product by developing control strategies to regulate all attribut...
August 10, 2017
The recently released reflection paper (draft) from the European Medicines Agency (EMA) aims to establish a framework and a common language to define the appropriate role of inferential statistical methods for comparative evaluation of drug product’s...
August 09, 2017
This article was originally published in the July – August 2017 issue of Pharmaceutical Engineering® magazine . Despite the advantages of ozone technology as a powerful commercially available oxidant and disinfectant, this technology has not been ado...
August 08, 2017
This article presents a consensus standardized extractables testing protocol for single-use systems in biomanufacturing This article was originally published in the November – December 2014 issue of Pharmaceutical Engineering® magazine. Missed Parts...
August 04, 2017
Name: Maria Rosario Barangan Title: Vice President Company Name: E.L. Laboratories, Inc. What attracted you to pharmaceutical engineering? My family has been in the pharmaceutical manufacturing industry for the last 50 years. My mother, who is also a...