General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
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GB/Z 42344-2023
Introduction
The GB/Z 42344-2023 Pharmaceutical Machinery (Equipment) Computerized System Validation Guideline provides comprehensive guidance for the validation of computerized systems used in the pharmaceutical industry. This guideline aims to ensure that computerized systems used in pharmaceutical manufacturing, testing, and other related activities are reliable, accurate, and compliant with relevant regulatory requirements.
The guideline covers various aspects of computerized system validation, including documentation requirements, validation process, risk assessment, and change control. It emphasizes the importance of a risk-based approach, where the level of validation activities is determined by the criticality of the system and its impact on product quality, safety, and data integrity.
The GB/Z 42344-2023 guideline also provides guidance on the qualification of computerized system vendors and the validation of commercial off-the-shelf (COTS) software. It highlights the need for thorough documentation, including validation plans, protocols, and reports, to ensure traceability and accountability throughout the validation process.
By following the recommendations in this guideline, pharmaceutical companies can ensure that their computerized systems are validated effectively and efficiently, reducing the risk of errors, deviations, and non-compliance. The GB/Z 42344-2023 Pharmaceutical Machinery (Equipment) Computerized System Validation Guideline serves as a valuable resource for pharmaceutical manufacturers, regulatory authorities, and other stakeholders involved in the validation of computerized systems in the pharmaceutical industry.
GB/Z 42344-2023 history
2023GB/Z 42344-2023 Guidelines for Validation of Pharmaceutical Machinery (Equipment) Computerized System