validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
Monday, January 1, 2018
Considerations for Cleaning Validation using Automated Washing Systems
What is cleaning validation and where does it fall in the global Life Cycle Validation scheme? How can an automated washing system be validated? This presentation provides insights that may help to respond to these questions. The Life Cycle Approach is a good way to standardize a company’s manufacturing and cleaning processes. The 2011 FDA Guidance document entitled: ‘’Process Validation: General Principles and Practices’’ describes process validation activities into 3 stages; Process Design, Process Qualification and Continued Process Verification. Join us to learn more about these three stages.
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Pharmaceutical Validation Documentation Requirements
Pharmaceutical validation is a critical process that ensures that pharmaceutical products meet the desired quality standards and are safe fo...
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K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
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Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid...
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Cold storage is a relatively simple cold room that is commonly used to store material between 2[degrees] to 8[degrees]C. Such cold rooms a...
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