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Abstract

Quality Assurance can be defined as a part of quality management focused on providing confidence that quality requirements will be fulfilled. Quality Control can be defined as a part of quality management focused on fulfilling quality requirements. When manufacturing, distributing, and marketing pharmaceutical products, quality assurance (QA), quality control (QC), and good manufacturing practice (GMP) are crucial factors to take into account in order to guarantee the products’ identity, potency, purity, pharmacological safety, efficacy, and effectiveness. The majority of international regulatory documents, such as those from the WHO, USFDA, MHRA, TGA, and others, define the terms quality assurance, quality control, and good manufacturing practices. The quality of the final product is closely linked to in-process quality control (IPQC) testing because good pharmaceutical dosage forms depend on checks made during manufacturing to monitor and, if needed, change the process to ensure that the product conforms to its specifications. A few of its components are identified and quality by design is explained in the overview. The foundation for this is the Q8 ICH guidelines for pharmaceutical development.

Keywords

Quality Control, Quality Assurance, Pharmaceutical dosage form, Specification, IPQC & FPQC

Reference

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Sayali Dilip Patil
Corresponding author

Assistant Professor, Pharmaceutics, SND College of Pharmacy Babhulgaon, Yeola, Maharashtra, India.

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Mayuri Kaduba Raut
Co-author

SND College of Pharmacy Babhulgaon, Yeola, Maharashtra, India.

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Nikhil Prakash Rathod
Co-author

SND College of Pharmacy Babhulgaon, Yeola, Maharashtra, India.

Sayali Dilip Patil*, Mayuri Kaduba Raut, Nikhil Prakash Rathod, Quality Control And Quality Assurance In Pharmaceuticals, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 11, 91-102. https://doi.org/10.5281/zenodo.10066235

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