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GAMP 5 - Good Automated Manufacturing Practice 5

GAMP 5, or Good Automated Manufacturing Practice 5, is a set of guidelines and best practices for the validation of automated systems in the pharmaceutical and biotechnology industries. It is published by the International Society for Pharmaceutical Engineering (ISPE), an organization that provides resources and expertise to professionals in the pharmaceutical and biopharmaceutical manufacturing industries.

GAMP 5 provides a structured approach to the validation of computerized systems used in the manufacturing and testing of pharmaceutical products. It addresses various aspects of computerized system validation, including hardware, software, and the entire system lifecycle. The primary goal of GAMP 5 is to ensure that these systems are implemented and maintained in a manner that meets regulatory requirements, maintains data integrity, and ensures product quality and patient safety.

Key features and principles of GAMP 5 include:

1. Risk-Based Approach: GAMP 5 emphasizes a risk-based approach to computerized system validation. It encourages companies to assess the potential risks associated with a system and prioritize validation efforts accordingly.
2. Lifecycle Approach: GAMP 5 considers the entire lifecycle of a computerized system, from concept through retirement. It provides guidance on activities such as system design, installation, operation, and maintenance.
3. Categories of Software: GAMP 5 categorizes software into different categories (Category 1 to 5), with each category having specific validation requirements based on the impact of the software on product quality and patient safety.
4. Validation Documentation: The guideline outlines the types of documentation required for validation, including user requirements, functional specifications, design specifications, and test protocols.
5. Change Control: GAMP 5 provides recommendations for managing changes to computerized systems and the associated validation activities to ensure ongoing compliance.
6. Supplier and Service Provider Assessment: It offers guidance on how to assess and manage the validation efforts of suppliers and service providers who provide software and systems to the pharmaceutical industry.
7. Data Integrity: GAMP 5 places a strong emphasis on data integrity and provides recommendations for ensuring that data generated and stored by computerized systems are accurate, complete, and secure.

GAMP 5 is widely recognized and adopted in the pharmaceutical and biotechnology industries as a valuable resource for ensuring the quality and compliance of computerized systems. It is used by professionals involved in the validation of manufacturing, laboratory, and other critical systems to meet regulatory requirements and industry best practices.