Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...

Charting by Exception, or CBE, is a method of documentation used in healthcare, particularly in nursing, that focuses on documenting only significant or abnormal findings rather than recording every detail. This approach aims to streamline the documentation process, improve efficiency, and ensure that healthcare providers can quickly identify deviations from normalcy in patient assessments.
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...

Critical thinking involves reflective and productive thinking and the evaluation of evidence. Critical thinkers seek to understand the deeper meaning of ideas, question assumptions, and make independent decisions about what to believe or do. Scientists, for instance, are often critical thinkers. Critical thinking also requires humility about what we know and don't know and the motivation to look beyond the obvious. It is essential for effective problem-solving.
Colleges and universities are...

Critical thinking helps decision-making and allows nurses to recognize barriers to success and find solutions to possible issues. It helps to brainstorm and implement ideas to achieve goals. Critical thinking helps acknowledge and state workflow inefficiencies while improving management techniques. Nurses understand the value of critical thinking and look for fellow nurses with critical thinking skills to upgrade their professional standards. Critical thinking can advance a nurse's career with...

Tuberculosis (TB) is a contagious infection primarily affecting the lung parenchyma but which can also affect other body parts. TB can be classified based on disease development, presentation, and the affected anatomical site.
The first classification is based on the development of the disease, and it includes the following categories: