In ANDA submissions, the FDA typically requires stability data for at least 180 days. This data is a part of the chemistry, manufacturing, and controls (CMC) section of the application. The purpose of stability studies is to demonstrate the drug product’s stability over time, ensuring its quality and efficacy throughout its shelf life. This…
1. Accelerated stability studies These studies involve subjecting the pharmaceutical product to higher temperatures and humidity levels than normal storage conditions to determine its stability over a shorter period of time. 2. Long-term stability studies These studies involve storing the pharmaceutical product under normal storage conditions for an extended period of time, typically up…
The drug approval process in the United States is overseen by the Food and Drug Administration (FDA), which ensures that drugs marketed in the country are safe and effective. Here are the general steps involved: 1. Preclinical Testing Before testing on humans, drugs undergo extensive laboratory and animal testing to assess their safety and…
The Abbreviated New Drug Application (ANDA) is a crucial regulatory pathway in the United States for the approval of generic drugs. This post provides a detailed overview of the ANDA process, its requirements, and significance in the pharmaceutical industry. 1. Purpose of ANDA ANDA allows pharmaceutical companies to demonstrate that their generic drug product…
Let’s exploring the Topics in GxP Compliance within the PharmaceuticalIndustry. 1. Good Manufacturing Practice (GMP) GMP ensures that pharmaceutical products are consistently produced and controlled according to quality standards. This includes guidelines for facilities, equipment, personnel, documentation, and processes. 2. Good Laboratory Practice (GLP) GLP ensures the reliability and integrity of non-clinical laboratory…
1. Method Development This is the initial stage where the test method is developed based on the specific requirements of the pharmaceutical product. It involves determining the analytical technique, selecting appropriate instruments and reagents , and establishing the method parameters. 2. Method Validation Once the test method is developed, it needs to be validated…
1. Acceptance Value (AV) calculation formula: AV = (Σ |C – T|) / n x 100 where AV is the acceptance value, C is the concentration of the analyte in each sample, T is the target concentration, and n is the number of samples analyzed. Reference: United States Pharmacopeia (USP) General Chapter <1225>…
There are several quality risk management trends in the pharmaceutical industry that have emerged in recent years. These trends aim to improve the overall quality and safety of pharmaceutical products and processes. Some of the key trends include: 1. Implementation of Quality by Design (QbD): QbD is an approach that focuses on building quality…
