Author(s):
Vikram Gharge, Ketaki Phadke, Archana Chaudhari, Vinayshri Salunkhe, Nidhi Tangade
Email(s):
vikram.gharge@zuventus.com
DOI:
10.52711/2231-5659.2025.00010 
Address:
Vikram Gharge*, Ketaki Phadke, Archana Chaudhari, Vinayshri Salunkhe, Nidhi Tangade
Department of formulation and development, Zuventus Healthcare Ltd. Plot no. P-2, SBM, Ground Floor (Part-B) and First Floor. I.T.B.T. Park, Phase –II, MIDC, Hinjawadi, Pune – 411057.
*Corresponding Author
Published In:
Volume - 15,
Issue - 1,
Year - 2025
ABSTRACT:
Comparative analysis of the quality control tests for in-process and finished oral solid dosage form specifically tablets and capsules across the recent editions of the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) United States Pharmacopoeia (USP). This study provides a detailed examination of the in-process quality control (IPQC) tests as per the recent editions of Indian Pharmacopoeia (IP) 2022 (Addendum 2024), British Pharmacopoeia (BP) 2024, and United States Pharmacopoeia (USP) 2023 (Issue 3) for oral solid dosage forms, primarily tablets and capsules. It highlights the quality control measures implemented to ensure that the final products confirm to established pharmacopoeial standards. The concept of total quality control involves a comprehensive approach to producing a high-quality product by implementing various measures to eliminate errors at every stage of production. In-process testing is conducted to ensure that the final product meets the compendial standards outlined in pharmacopoeias. Since the final sample used for testing is only a representative sample from a larger batch, there may still be variability. Pharmacopoeias define specific limits within which values must fall to comply with the established standards. These official pharmacopoeias, recognized globally, outline the quality requirements for pharmaceutical products. The purpose of this review is to list the quality control tests, their differences, and similarities in relation to the pharmacopoeias stated above. The review covers various IPQC tests, including those related to physical, chemical, and microbiological attributes, and discusses the specific limits and criteria set by each pharmacopoeia. The study underscores both the similarities and differences in quality requirements among these pharmacopoeias. The review shows that IP, BP, and USP have similar quality control tests, but they each have their own specific requirements and methods for these tests. This divergence reflects the individual pharmacopoeias’ unique approaches to ensuring product quality. Understanding these differences is crucial for pharmaceutical manufacturers to ensure compliance with relevant pharmacopoeial standards and to maintain the quality and safety of oral solid dosage forms across different markets.
Cite this article:
Vikram Gharge, Ketaki Phadke, Archana Chaudhari, Vinayshri Salunkhe, Nidhi Tangade. A Review of Comparative study of in-Process Quality Control Tests as Per IP, BP and USP for Solid Dosage Forms. Asian Journal of Research in Pharmaceutical Sciences. 2025; 15(1):68-6. doi: 10.52711/2231-5659.2025.00010
Cite(Electronic):
Vikram Gharge, Ketaki Phadke, Archana Chaudhari, Vinayshri Salunkhe, Nidhi Tangade. A Review of Comparative study of in-Process Quality Control Tests as Per IP, BP and USP for Solid Dosage Forms. Asian Journal of Research in Pharmaceutical Sciences. 2025; 15(1):68-6. doi: 10.52711/2231-5659.2025.00010 Available on: https://ajpsonline.com/AbstractView.aspx?PID=2025-15-1-10
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