Research Journal of Pharmacy and Technology
SCOPUS
  • Year: 2026
  • Volume: 19
  • Issue: 1

A Review on Assurance and Compliance of Manufacturing of Tablets Following ICH Q10

  • Author:
  • Prashant Nayak1, Abhishek Kumar2,*, Raj Kumar Singh1, K R Krishnapriya2, M Chandana Adiga2
  • Total Page Count: 5
  • Published Online: May 29, 2026
  • Page Number: 490 to 494

1Nitte (Deemed to be University), NGSM Institute of Pharmaceutical Sciences (NGSMIPS), Department of Pharmaceutics, Mangalore, India

2Nitte (Deemed to be University), NGSM Institute of Pharmaceutical Sciences (NGSMIPS), Department of Pharmaceutical Chemistry, Mangalore, India

*Corresponding Author E-mail: abhi12bunty@nitte.edu.in

Online Published on 29 May, 2026.

Abstract

Quality assurance in the pharmaceutical industry aims to ensure that the product that reaches the patient is safe, effective, and of better quality. Product quality is checked by various activities of quality systems such as managerial and technical, including evaluation of pharmaceutical products documentation, performing or reviewing quality-control laboratory tests, and monitoring product performance. Managerial activities include selecting reliable suppliers, preparing contract terms, monitoring supplier performance, and performing inspection trials during the distribution network. Compliance Services assures that the labs are operating within global regulatory requirements. By assuring the provider agrees on the protocols under a single Universal Operational Qualification framework, it will have a comprehensive, automated approach to investigation, documentation, and agreement, streamlining processes across all leading pharmaceutical industry models. In pharmaceutical industries, tablet dosage forms should follow the Q10 guidelines of ICH. The models and statistical approaches should qualify as per the guidelines. Observation should be done throughout the life cycle of the tablet dosage form.

Keywords

Quality assurance, ICH Q10, Tablet