by RJTimko | Jan 22, 2024 | Quality
Introduction Drug Product Quality is a term one should be familiar with as part of routine drug development and manufacture. Recently while working with a small pharmaceutical company and their contracted development organization, an Incident Report documented the...
by RJTimko | Jan 22, 2024 | Processing
The discovery, development and commercialization of a novel drug entity is not a quick or easy endeavor. Many compounds fail during safety and/or clinical testing for a variety of reasons. In addition, the compound may demonstrate chemical or physical characteristics...
by RJTimko | Feb 16, 2022 | Knowledge Management
Keeping track of data, development reports and other important documents for a given project for potential future need is always a concern for companies. Individuals working on a project may change; some will leave for other opportunities, and individual’s memories...
by RJTimko | Jan 27, 2022 | Knowledge Management
Several years ago, I wrote about the relationships among date of manufacture, in-process hold times and drug product expiration date. Since then, there have been some developments that are worth revisiting. The corresponding guidelines of EMA (The European Medicines...
by RJTimko | Jun 6, 2019 | Botanicals
Introduction The use of plants as to treat various human maladies has been known since ancient times. Many of today’s drug products contain plant-derived ingredients. Botanical products may be classified as foods, dietary supplements, drugs, medical devices,...
