CAPA stands for Corrective Action and Preventive Action. It is a tool used in quality management systems in the pharmaceutical industry. The purpose of corrective and preventive action is to analyze, identify problems, and implement appropriate measures to prevent their recurrence. CAPA meanings/ Definition Corrective action is the action taken to eliminate the causes of … Read more
User requirement specification (URS) is a list of all the equipment-related requirements from the user, The list shall be prepared based on the types of equipment to be purchased. After the preparation of the list, the URS documents are sent to the manufacturer to get the required materials as per the given criteria. The user department … Read more
Pharmaceutical products are generally contaminated by microorganisms, cleaning agents, or other materials, But in many cases, it may be due to the repeated use of the same equipment for processing. To avoid this problem FDA introduced the Cleaning method validation process for pharmaceutical industries. The cleaning procedure must be strictly followed to execute the cleaning method. Normally … Read more
Validation is the established document evidence or proof that provides a high degree of assurance. A particular method can systematically produce a product that meets its predetermined specifications and quality attributes. Process validation is also a component of the validation, which is explained below. Introduction to Pharmaceutical Validation: The Importance of Validation in Pharmaceutical Validation … Read more