Abstract

DOCUMENTATION ESSENTIALS IN THE PHARMACEUTICAL INDUSTRY: A REGULATORY PERSPECTIVE

Nilam D. Chingale*, Sushil D. Walunj, Mrunal S. Kikale, Omkar A. Devade and Vivekkumar Redasani

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Abstract

Documentation plays a pivotal role in the pharmaceutical industry, serving as a cornerstone for compliance, quality assurance, and overall operational efficiency. This abstract highlights the critical importance of documentation practices within pharmaceutical companies. It explores how meticulous documentation not only ensures adherence to regulatory requirements but also facilitates the maintenance of highquality standards throughout the product lifecycle. By providing a comprehensive overview of the types of documentation involved, including batch records, standard operating procedures (SOPs), and regulatory filings, this abstract underscores the multifaceted nature of documentation in pharmaceutical manufacturing, research, and development. Ultimately, this abstract emphasizes the indispensable role of documentation in safeguarding public health, fostering innovation, and sustaining the integrity of the pharmaceutical industry.

Keywords: Hierarchical Document System, BMR, MFR, DMF, Audit trails, Blockchain.