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@article{183334,
        author = {Mrs. Meenakshi. S. Mandavkar and Mr. Atharva R. Sankhe and Miss. Srushti D. Raut and Mr. Varad D. Sangare},
        title = {REVIEW ON INTERNATIONAL COUNCIL FOR HARMONISATION GUIDELINE Q12},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {3},
        pages = {853-860},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=183334},
        abstract = {The pharmaceutical industry operates within a strictly regulated environment to ensure the effectiveness, safety, and quality of pharmaceutical products [9]. The International Council for Harmonization (ICH) Q12 guideline, titled "Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management," provides a structured framework for managing post-approval modifications efficiently and scientifically [4]. Introduced as a supplement to previous ICH guidelines (Q8–Q11), ICH Q12 enhances regulatory flexibility while maintaining rigorous product quality standards [3].
A central component of ICH Q12 is the concept of Established Conditions (ECs), which define critical quality attributes and process parameters requiring regulatory oversight [13]. Additionally, the guideline introduces the Post-Approval Change Management Protocol (PACMP) to support manufacturers in implementing modifications more efficiently and predictably [12]. The Product Lifecycle Management (PLCM) Document further ensures consistency in managing product changes over time by promoting transparent communication with regulatory agencies [16].
The implementation of ICH Q12 varies across global regulatory bodies, and achieving harmonization remains challenging due to differences in regional regulatory expectations [11]. Despite these challenges, ICH Q12 represents a significant advancement in lifecycle management, enabling pharmaceutical companies to adopt continuous improvement strategies without compromising regulatory compliance [8]. This review provides a comprehensive analysis of ICH Q12, discussing its fundamental components, regulatory implications, practical challenges, and overall scope. Furthermore, the guideline's impact on international pharmaceutical operations and its potential to drive innovation while preserving product integrity are critically examined [15].},
        keywords = {Pharmacy, Pharmaceutical, Guideline, Q12, ICH, Regulatory affairs},
        month = {August},
        }