Good Automated Manufacturing Practices (GAMP) are guidelines for validating computerized systems in the pharmaceutical and healthcare sectors, developed by the International Society for Pharmaceutical Engineering (ISPE). Key principles include a risk-based and lifecycle approach to validation, comprehensive documentation requirements, vendor assessment, change control, personnel training, and compliance monitoring. Overall, GAMP aims to ensure that computerized systems are reliable, meet regulatory standards, and maintain product quality and patient safety.

1. Good Automated Manufacturing
Practices(GAMP)
Mrs. Poonam Sunil Aher (M Pharm)
Sanjivani College of Pharmaceutical Education and Research
(Autonomous),
Kopargaon, Ahmednagar-423603 (M.S.), INDIA
poonamprakashpatil4174@gmail.com

2. GAMP
• GAMP, which stands for "Good Automated Manufacturing
Practice," is a set of guidelines and best practices for the validation
of computerized systems in the pharmaceutical and healthcare
industries. It was developed by the International Society for
Pharmaceutical Engineering (ISPE).
• GAMP provides a framework for ensuring that computerized
systems used in pharmaceutical manufacturing, laboratory
analysis, and other regulated processes are fit for their intended
use, comply with regulatory requirements, and operate in a
consistent and reliable manner.

3. • Key principles and components of GAMP include:
• Risk-Based Approach:
• GAMP emphasizes a risk-based approach to validation, where the level of validation effort is proportional to
the risk posed by the system to product quality, patient safety, and data integrity. This approach involves
identifying and assessing potential risks associated with computerized systems and prioritizing validation
activities accordingly.
• Lifecycle Approach:
• GAMP promotes a lifecycle approach to computerized system validation, which involves planning,
specification, testing, operation, maintenance, and retirement phases. Validation activities are conducted
throughout the entire lifecycle of the system, from initial development through to decommissioning.

4. • Validation Documentation:
• GAMP provides guidance on the documentation required for computerized system validation, including
validation plans, user requirements specifications (URS), functional specifications, design specifications, test
protocols, and validation reports. Documentation should be comprehensive, well-organized, and maintained
throughout the lifecycle of the system.
• Vendor Assessment and Control:
• GAMP recommends assessing and controlling vendors of computerized systems to ensure that products and
services meet regulatory requirements and industry standards. This includes evaluating vendor capabilities,
performing supplier audits, and establishing clear contractual agreements regarding system validation and support.

5. • Change Control and Configuration Management:
• GAMP emphasizes the importance of change control and configuration management processes to ensure that
modifications to computerized systems are properly evaluated, documented, and validated. Changes to validated
systems should be carefully assessed for potential impact on product quality, safety, and compliance.
• Training and Personnel Competence:
• GAMP highlights the importance of providing training and ensuring the competence of personnel involved in the
development, operation, maintenance, and validation of computerized systems. Training programs should cover
relevant procedures, policies, and regulatory requirements.
• Auditing and Compliance Monitoring:
• GAMP encourages the implementation of auditing and compliance monitoring processes to verify that computerized
systems are operating in accordance with established procedures, regulatory requirements, and industry standards.
Internal and external audits may be conducted to assess system compliance and identify areas for improvement.
• Overall, GAMP provides a systematic approach to computerized system validation, helping organizations in the
pharmaceutical and healthcare industries ensure the reliability, integrity, and compliance of their computerized
systems throughout their lifecycle.

6. •THANK YOU