This article presents a method to account for missing information and provides recommendations to understand a legacy product and how to apply the three stages of the new guidance to satisfy the FDA and other regulatory agencies.
A Review of the Regulations and International Developments on Quality and Supply Chain Integrity of Pharmaceutical Excipients
This article presents an overview of the regulations and international developments on quality and supply chain integrity of pharmaceutical excipients, analyzing the challenges faced by regulatory authorities with recommendations to improve the excipient control framework.
Risk Analysis and Annual Training Program Definition
Seven common mistakes are identified when responding to FDA inspection observations. This article presents examples of regulated-industry responses that may not meet the FDA requirements for a thorough response.
Scientific and Regulatory Considerations for Implementing Mathematical Models in the Quality by Design (QbD) Framework (Part 1 of 2)
by Theodora Kourti, John Lepore, Lorenz Liesum, Moheb Nasr, Sharmista Chatterjee, Christine M.V. Moore and Evdokia Korakianiti, May/June 2015.
This article is the first of a two-part series and presents points to consider for building and using models in the regulated pharmaceutical industry and offers examples of how models can play a part in the Quality by Design (QbD) framework.
Content Uniformity Discussions: Current USP Developments Regarding and a Comparison of Two Relevant Statistical Approaches to Assess Content Uniformity
by James Bergum, William Brown, Jon Clark, Thomas Parks, Thomas Garcia, James Prescott, Charles Hoiberg, Sami Patel, and Ravindra Tejwani, July/August 2015.
Compare the performance of two statistical approaches (tolerance interval and ASTM E2709/E2810) to assess dosage unit uniformity. The potential impact that the approaches can have on the USP monograph is also discussed.
About the Roger F. Sherwood Article of the Year Award
Pharmaceutical Engineering has established an "Article of the Year" award to recognize the contribution of authors. Articles are evaluated by a panel of volunteer reviewers according to a number of criteria, concentrating on the importance and timeliness of the subject matter and the quality of the presentation.
Each year many people start off with how they are going to be better than the year before and write down unrealistic goals about their professional and personal time next the 365 days.
Our team at Women in Pharma® has sat down and put together a...
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2019. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...
Since April 2017, the European Pharmacopeia allows to produce Water for Injection (WFI) using other methods than distillation. Meanwhile, the additional water quality "Highly Purified Water" (HPW) could be found in the Ph. Eur. but will be removed in...