GAMP, which stands for Good Automated Manufacturing Practice, is a risk-based approach to computer system validation used primarily in the pharmaceutical and life sciences industries.
Here's a breakdown:
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Validation Context: GAMP focuses on ensuring that computerized systems used in regulated manufacturing environments (e.g., drug production) consistently perform as intended. This is critical for product quality, patient safety, and regulatory compliance.
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Risk-Based Approach: Instead of applying the same validation effort to every system, GAMP advocates for a risk-based approach. This means evaluating systems based on their intended use and complexity, and then tailoring validation activities accordingly. Higher-risk systems (those with a direct impact on product quality) receive more rigorous testing and documentation.
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Categorization: GAMP categorizes systems into different levels, often based on the degree of configuration and customization. Examples of categories include:
- Category 1: Infrastructure Software: Operating systems, database management systems.
- Category 3: Non-Configured Products: Off-the-shelf software with no configuration.
- Category 4: Configured Products: Software that requires some configuration to meet the user's needs.
- Category 5: Custom Applications: Software developed specifically for a particular purpose.
The category assigned to a system dictates the level of validation effort required.
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Validation Lifecycle: GAMP emphasizes a structured validation lifecycle, including planning, specification, design, testing, implementation, and maintenance. This ensures a systematic and documented approach to validation.
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Key Principles: The core principles of GAMP include:
- Product and Process Understanding: A thorough understanding of the product and manufacturing process is essential for effective validation.
- Lifecycle Approach: Managing the system's lifecycle from design to retirement.
- Quality Risk Management: Identifying, assessing, and controlling risks throughout the system's lifecycle.
- Leveraging Supplier Knowledge: Utilizing the expertise and documentation provided by software vendors.
- Scalability: Tailoring the validation approach to the complexity and risk of the system.
In essence, GAMP provides a framework and best practices for validating computerized systems in regulated industries, helping companies demonstrate that their systems are fit for their intended purpose and comply with regulatory requirements.
