A REVIEW ON DOCUMENTATION IN PHARMACEUTICAL INDUSTRY
Harshal S. Janjal, Dr.Swati S. Rawat, Dr. Sunil S. Jaybhaye, Mr. Yogiraj P. Muley, Ms. Komal D. Kangne
Institute of Pharmacy, Badnapur, Dist. Jalna, Maharashtra
Abstract
In the pharmaceutical industry, documentation is critical for ensuring product quality, regulatory compliance, and operational efficiency. This process involves the creation, management, and storage of various documents, such as Standard Operating Procedures (SOPs), batch records, validation protocols, and reports. Pharmaceutical documentation serves as the foundation for traceability and transparency across all phases of drug development, manufacturing, and distribution. Effective documentation practices help prevent errors, facilitate audits, and ensure adherence to Good Manufacturing Practices (GMP). Regulatory authorities such as the FDA and EMA require accurate and up-to-date documentation to evaluate compliance with safety and quality standards. The industry relies on a structured approach to documentation, incorporating both manual and electronic systems, to manage the vast amount of data and ensure the integrity of the information recorded. This abstract discusses the importance of proper documentation management and the challenges faced by the industry in maintaining accuracy, consistency, and compliance.
Keywords: Documentation in pharmaceutical industry, Good documentation practices (GDP), Quality control Documentation in pharmaceutical industry
Journal Name :
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EPRA International Journal of Research & Development (IJRD)
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Published on : 2024-11-27
Vol | : | 9 |
Issue | : | 11 |
Month | : | November |
Year | : | 2024 |