Monthly Archives: November 2015

Management of Corrective and Preventive Action (CA-PA)

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 … Continue reading

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Discussion for establishment of risk based approach on airflow visualization in cleanrooms

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 … Continue reading

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Popular methods of Risk Assessment (Part-II)

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 … Continue reading

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Popular methods of Risk Assessment (Part I)

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, … Continue reading

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Label Control

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. … Continue reading

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