Our previous review of humorous and horrifying pharmaceutical facilities blunders Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them) revealed our industry is flawed like any other. Here are some examples from the engineering side of the business.
FDA requirements and compendial standards for pharmacy compounding and outsourcing continue to evolve, and the FDA has different requirements for products prepared through pharmacy compounding practices as compared to those manufactured for use in clinical studies.
Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.
In this article we explore five important questions that can serve as a brief checklist to help drug companies both figure out and communicate their expectations to suppliers and understand their suppliers’ expectations.
The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.
The forced degradation study is a vital analytical aspect of the drug development program for small molecules. Commonly known as stress testing, it is carried out to demonstrate as specificity to developed a stability-indicating analytical method, using high-performance liquid chromatography (HPLC). As per ICH Q1A, stability studies must be performed to propose the shelf life of new drug substances and/or drug products.
Cell and gene therapies have a level of complexity from a supply chain perspective that needs new approaches, including a high level of information sharing and integration. This topic was covered from different perspectives at two recent conferences.
There are many reasons for issues to crop up in a supply chain. For some, there aren’t realistic, economical work-arounds available to every company to mitigate all consequences.
In Oct. 2019, the FDA’s Drug Shortage Task Force published a report that identified root causes of drug shortages across the U.S. healthcare system and made recommendations for effectively resolving those underlying issues. This article summarizes the report’s findings and discusses potential next steps the FDA may take.
When is the best time to start quality by design (QbD)? This question is asked most frequently among many small firms. A better way to phrase it is: When should I formally document my QbD activities?