Forced degradation is not that simple as it seems where you just degrade with Acid, base, oxidation, light, light and present the data in a table form. It is elaborate study where we evaluate each or every impurity and discuss the potential risk. It is also a risk assessment tool. It goes beyond stressing the…
Photolytic Degradation Photolytic degradation is a type of forced degradation that occurs when a drug molecule is exposed to light. The photolytic degradation process typically involves three steps: 1. Light Absorption: The first step in photolytic degradation is the absorption of light by the target molecule. Different molecules have varying abilities to absorb light…
Oxidation Degradation Oxidation is the second most common degradation pathway for pharmaceuticals, after hydrolysis. Oxidation degradation studies are conducted in the pharmaceutical industry to determine the stability of drugs under conditions that may induce oxidation, such as exposure to light, heat, or oxygen. The goal of these studies is to identify the degradation products…
1. Establish a robust CAPA process: Implement a well-defined and documented Corrective and Preventive Action (CAPA) process that is aligned with regulatory requirements. 2. Train employees: Provide comprehensive training to employees on the CAPA process, including how to identify and report issues, and how to implement effective corrective and preventive actions. 3. Foster…
Linearity earity is one of the key parameters assessed during method validation. It refers to the ability of an analytical method to produce results that are directly proportional to the concentration or amount of the analyte within a specific range When a method is linear, it means that the response of the measurement instrument…
Clean Room Pressure Cascades When considering pressures cascades, consider a design concept to have a “clean corridor” or a “dirty corridor” design ,typically, low moisture drugs such as tablets or capsules are dry and dusty, therefore more likely to be a significant cross-contamination risk. If the “clean” area pressure differential were positive to the corridor,…
A standard operating procedure (SOP) provides clear-cut directions and detailed instructions needed to perform a specific task or operation consistently and efficiently. The fundamental purpose of an SOP is to provide clear and concise instructions for the consistent execution of routine operations within an organization. By offering a step-by-step guide on how tasks…
A new Warning Letter has been issued by the U.S. Food and Drug Administration (FDA) and published on their website on August 1, 2023. The document, dated July 28, 2023, pertains to an inspection from November 22 to December 2, 2022, at a drug manufacturing facility in Sanand (Gujarat, India). The company under scrutiny is…
