The concept of Corrective and Preventive Action (CAPA) has doesn’t specifically appear in the older version of Good Manufacturing Practices. CAPA seems to have become popular in the pharmaceutical industry because of its use with medical devices.[ISO 13495:2003 and the FDA’s 1996 Quality System Regulation (QSR) for medical devices, include CAPA. This requirement for medical […]
Smoke study or air flow visualization is the important factor in clean room qualification. My query to some experts were as following 1. What will be the requalification frequency for Smoke study?2. If there is no significant changes in the clean room design is it require to do periodic evaluation of smoke study?3. Any Guidance […]
Fault tree analysis The fault tree analysis (FTA) was first introduced by Bell Laboratories and is one of the most widely used methods in system reliability, maintainability and safety analysis. It is a deductive procedure used to determine the various combinations of hardware and software failures and human errors that could cause undesired events (referred […]
Failure Mode Effects Analysis (FMEA) Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. “Failure modes” means the ways, or modes, in which something might fail. Failures are any errors or defects, especially ones that affect […]
Overview Controlling the storage and issuing of labels and labeling helps prevent mix-ups. Technology, such as bar-codes and vision systems, has reduced the number of label – related recalls, but controlling label storage and issuance is still very important. General Precautions 1. When setting up a program for the packaging operations, particular attention should […]
