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Pharmaceutical Quality Management System (QMS) Questions and Answers
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This Book contains regarding Pharmaceutical Quality Management System (QMS) and its related guidelines as well as the Questions and Answers of Change control, Deviation and Corrective Action and Preventive action (CAPA).This Questions and answers are very useful for the persons working in Pharmaceutical industry.
LanguageEnglish
PublisherChandrasekhar Panda
Release dateJan 13, 2024
ISBN9798224530670
Author
Chandrasekhar Panda
The Author of this Book is Mr Chandrasekhar Panda with Educational Qualification of Bachelor of Pharmacy with more than 17 years of Experience in Pharmaceutical Industry Quality Assurance.
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Pharmaceutical Quality Management System (QMS) Questions and Answers - Chandrasekhar Panda
Definition of Quality in the Pharmaceutical Industry:
Quality in the pharmaceutical industry refers to the degree to which a drug substance or product meets its intended use and fulfills its inherent properties. This definition includes essential attributes like the drug’s identity, strength, and purity.
The quality of a drug is critical for patient safety and effective treatment. If a drug is contaminated or not pure, it could cause harm to patients. Similarly, if a drug is not potent enough, it may not be effective in treating the condition for which it was intended.
Before pharmaceutical products are approved for human use, they must comply with regulatory requirements. In this regard, a Pharmaceutical Quality System (PQS) includes all processes of a system that helps ensure quality in the pharmaceutical product lifecycle.
What is Pharmaceutical Quality Management System (QMS):
Pharmaceutical Quality Management System (QMS) is a comprehensive collection of policies, processes, and procedures designed to ensure and maintain uniform and high quality in the production of pharmaceutical products.
The QMS must reflect the specific needs of the pharmaceutical company and applicable regulatory requirements.
A robust Pharmaceutical Quality System (PQS) that reflects the applicable requirements can also help pharmaceutical companies to mitigate risks, improve customer satisfaction, and streamline quality processes.
The pharmaceutical quality management system includes several processes, such as:
Document management
Change control
Audit management
CAPA management
Deviation management
The quality system uses monitoring methods such as Quality Assurance to prevent quality deviations and emphasizes quality system documentation to record all problems and their solutions.
Applicable Pharmaceutical QMS Regulations and Standards
Establishing and working according to the Quality Management System (QMS) is a requirement in the pharmaceutical industry. To
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