The Positive and Negative Impact of Deviations and Incidents During the Validation Process of GMP Equipment in the Pharmaceutical Industry

Introduction Good Manufacturing Practices (GMP) are the cornerstone of the pharmaceutical industry, ensuring that pharmaceutical products are produced consistently, safely, and effectively. The validation process is a critical component of GMP compliance, as it verifies that equipment and processes meet predefined standards and specifications. However, deviations and incidents during this validation process can have both…

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Computer System Validation (CSV) in the Pharmaceutical Industry: Ensuring Compliance and Data Integrity

In the pharmaceutical industry, the term “CSV” refers to Computer System Validation. This process is crucial for ensuring that computer systems used in drug manufacturing, testing, and distribution meet regulatory requirements, thereby maintaining data integrity and accuracy. Such validation is essential for patient safety and compliance with regulations set by bodies like the EMA, FDA,…

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