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@article{170985,
        author = {Sonu Thakur and Prachi D Nahar and Brajesh Rajak and Sunil K Suman},
        title = {A Systematic Approach to Achieve Quality Standards by Quality Risk Management as Per ICH Q9},
        journal = {International Journal of Innovative Research in Technology},
        year = {2024},
        volume = {11},
        number = {7},
        pages = {1879-1886},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=170985},
        abstract = {The objective is to establish a Standard Operating Procedure that will offer a methodical approach to meeting quality standards through the evaluation, management, communication, and review of risks associated with goods, machinery, utilities, facilities, QMS (such as change control, deviation, OOS, OOT, market complaints, self-inspection QA analytical review, etc.), GMP computer systems, and the environment. This guideline offers quality risk management concepts and tool examples that can be used for various pharmaceutical quality concerns. Throughout the lifecycle of drug substances, drug (medicinal) products, biological, and biotechnological products (including the use of raw materials, solvents, excipients, packaging, and labeling materials in drug (medicinal) products, biological, and biotechnological products), these aspects include development, manufacturing, distribution, and the inspection and submission/review processes.},
        keywords = {Risk Priority Number, Key Quality Risk Management, Risk Assessment, Risk Acceptance, Risk Control.},
        month = {December},
        }