Steps and requirements of preparing trial master file and clinical trial manufacturing documentation

Sachin L. Sanap; Vinita V. Kale; Suankit A. Harane; Milind J. Umekar

doi:10.18203/2349-3259.ijct20252204

Authors

Sachin L. Sanap Department of Regulatory Affairs, SMT. Kishoritai Bhoyar College of Pharmacy Kamptee, Nagpur, Maharashtra, India
Vinita V. Kale Department of Regulatory Affairs, SMT. Kishoritai Bhoyar College of Pharmacy Kamptee, Nagpur, Maharashtra, India
Suankit A. Harane Department of Regulatory Affairs, SMT. Kishoritai Bhoyar College of Pharmacy Kamptee, Nagpur, Maharashtra, India
Milind J. Umekar Department of Pharmaceutics, SMT. Kishoritai Bhoyar College of Pharmacy Kamptee, Nagpur, Maharashtra, India

DOI:

https://doi.org/10.18203/2349-3259.ijct20252204

Keywords:

Clinical trial manufacturing, eTMF, Good clinical practices, Regulatory compliance, Trial master file

Abstract

The preparation of a trial master file (TMF) and clinical trial manufacturing documentation is fundamental to ensuring regulatory compliance, maintaining data integrity and supporting the successful execution of clinical trials. A well-organized TMF serves as a key repository for essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated, ensuring adherence to ICH-GCP (E6 R2), FDA, EMA and MHRA guidelines. With the increasing adoption of electronic trial master files (eTMF), sponsors and clinical research organizations (CROs) are transitioning towards centralized digital platforms to enhance data management, reduce compliance risks and facilitate real-time monitoring. This transition, however, presents challenges such as data migration complexities, system validation and maintaining audit readiness. Clinical trial manufacturing documentation plays a crucial role in ensuring the safety, quality and efficacy of investigational medicinal products (IMPs). Key documentation includes investigational medicinal product dossiers (IMPDs), master and batch manufacturing records (MBR/BMR), certificates of analysis (CoA), packaging and labelling records, stability reports and deviation/CAPA Reports. Compliance with good manufacturing practices (GMP), 21 CFR Part 211 and EU Annex 13 is essential to meet global regulatory expectations. Proper documentation ensures that clinical trial materials are manufactured, tested and distributed in accordance with predefined standards. This review outlines the stepwise process involved in preparing and managing a TMF and clinical trial manufacturing documentation. It highlights best practices for document organization, quality control and regulatory compliance, while also addressing challenges such as incomplete documentation, audit findings and evolving regulatory landscapes. Furthermore, the paper discusses the impact of digital transformation, including the role of artificial intelligence (AI) and blockchain in enhancing documentation security, efficiency and traceability.

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