EXPLORING DOCUMENTATION IN MODERN PHARMACEUTICAL PRODUCTION AND MARKETING

Kritika Meshram*, Krutika Burange, Lavannya Fating, Lalit Wange, Krunal Takarkhed

ABSTRACT

In the pharmaceutical industry, documentation is a key element of quality, safety, and compliance, and includes the master formula record (MFR), which is prepared by the research and development department and includes detailed information about the exact ingredients, raw material specifications, and the manufacturing steps required to create a product, the batch manufacturing record (BMR), which is a historical document that contains information about each step of the manufacturing process for an individual batch, including raw materials, equipment, and operators to ensure traceability, and standard operating procedures (SOPs), which provide written, step-by-step instructions for routine operations that help ensure accuracy, productivity, and consistency in pharmaceutical practices. Regulatory authorities at the national and international level also take a vital role in protecting public health by assessing the safety, efficacy, and quality. Additionally, dossiers serve as official submissions to these authorities, containing comprehensive information on product safety, efficacy, manufacturing, labelling, and compliance, thereby enabling approval for international marketing. Collectively, these documentation practices form the backbone of modern pharmaceutical production and marketing, ensuring high-quality medicines and global regulatory compliance.

Keywords: Indian regulatory authorities, CDSCO, USFDA, GMP, Integrated system.