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
FDA 21 CFR Part 11 Webinar
Learn how pharmaceutical and medical device manufacturers can comply with the FDAs 21 CFR Part 11 regulations. NiceLabel will explain what is needed to comply with regulations pertaining to electronic records, electronic signatures, and audit trails. NiceLabel's Control Center Enterprise is the perfect software for FDA regulated companies that need label lifecycle management. Global organizations can consolidate their printing from each region and centralize on a single NiceLabel platform.
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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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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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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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