Production must follow all Principles of cGMP in order to get Quality defined by Regulatory Authorities. As per EudraLex Volume 4: 1. Production should be performed and supervised by trained & qualified staff. All handling of materials and products, such as receipt and quarantine, sampling, storage, labelling, dispensing, processing, packaging and distribution should be…
Inspection and audit are two distinct processes used to assess compliance with various guidelines and standards, including ISO 9001, FDA, EMA, and others. Here’s a breakdown of the key differences between inspection and audit based on these guidelines: Purpose: – Inspection: Inspections verify compliance with specific regulations or guidelines, focusing on identifying non-compliance issues…
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,…
