“In many organization, politics are allowed to influence the CAPAs simply because there are too many people involved in the approval process—approval to actually open a CAPA, or approval to finish one. Very often there are too many people, or the wrong people, in the approval process. I’ve seen real problems get swept under…
Non-sink conditions refer to situations where the concentration of the drug substance in the dissolution medium is not significantly lower than its solubility. While sink conditions are commonly preferred in dissolution testing to ensure rapid and complete drug dissolution, there are certain instances where non-sink conditions can be useful. Here are a few examples:…
Sink conditions refer to a state in which the dissolution medium has sufficient volume to ensure the drug dissolves rapidly without reaching saturation throughout the duration of the test. Sink conditions = V/Vsat ≥ 3 Where, Volume of Dissolution Medium The volume of the dissolution medium should be at least 3-10 times the saturation…
In Europe, The EMA coordinates the assessment of reports of product quality defects of centrally authorized medicines. Medicinal products with a quality defect are not of the correct quality as defined by their marketing authorization. It is important to report these defects in a timely manner because sometimes it is necessary to implement…
Corrective and Preventive Action (CAPA) was first formally introduced by the U.S. Food and Drug Administration (FDA) in 2006 as a component of the Quality Systems Guidance. This guidance would go on to form the basis of the ICH Q10. Since then, it’s found its way into the EU GMP Guide, laying out the…
Root Cause Analysis (RCA) is a problem-solving methodology that steps you through the RCA process. Each RCA process phase has a range of root cause analysis tools that you can use. The RCA process starts at the problem event then moves through evidence collection, investigation, analysis, developing corrective actions to address the problem or…
Cleaning validation is a regulatory requirement in pharmaceutical industry. It ensures that the cleaning process can removes the API residue from machine or equipment and make ready for next product. In this article we discuss about good cleaning validation practice in pharmaceutical industry. 1. Define the scope of the cleaning validation study Determine which…
Pharmaceutical tablets must meet their physical specifications and quality standards for ensuring safety and efficacy. These include weight variation, content uniformity, hardness, thickness, friability, disintegration, and dissolution. These factors must be controlled during production (in-process controls) and verified after the production of each batch to ensure that established product quality standards are met. Weight…
