In Process And Finished Product Quality Control Tests For Sterile And Non-Sterile Dosage Form.

Sachin S Sapkal , Tejashree R Kedar , Prasad B Tanpure , Sagar R Kale , Sadiya S Inamdar

Quality control , Pharmaceutical manufacturing, Sterile dosage forms,Non-sterile dosage forms.

This review article presents a comprehensive overview of the in process and finished product quality control tests essential for ensuring the safety, efficacy, and quality of both sterile and non-sterile dosage forms within the pharmaceutical industry. The article delves into the critical role of quality control in safeguarding public health and maintaining regulatory compliance. A detailed examination of In-process quality control (IPQC) is provided, encompassing tests for raw materials, intermediate products, and in-process materials. The article highlights the importance of IPQC in identifying and rectifying potential issues early in the manufacturing process, thereby minimizing risks and ensuring product integrity. Furthermore, the review explores finished product quality control (FPQC), focusing on the comprehensive testing of final products to verify their adherence to established specifications. Key FPQC tests, including identity, assay, purity, physical properties, chemical stability, bioavailability, sterility, pyrogen, particulate matter, and package integrity testing, are discussed in detail. The article specifically addresses the unique quality control requirements for sterile and non-sterile dosage forms. For sterile products, such as injections and ophthalmic solutions, the importance of sterility testing, pyrogen testing, particulate matter testing, and package integrity testing is emphasized. In contrast, non-sterile dosage forms, including tablets and capsules, require rigorous evaluation of dissolution, disintegration, uniformity of dosage units, and content uniformity.

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"In Process And Finished Product Quality Control Tests For Sterile And Non-Sterile Dosage Form.", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.9, Issue 10, page no.c300-c305, October-2024, Available :https://ijnrd.org/papers/IJNRD2410239.pdf

Volume 9 Issue 10, October-2024

Pages : c300-c305

Paper Reg. ID: IJNRD_301444

Published Paper Id: IJNRD2410239

Downloads: 00035

Research Area: Pharmacy All

Country: Ahilyanagar , Maharashtra , India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2410239

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2410239

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJNRD (IJ Publication) Janvi Wave

This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition