A REVIEW ON: GOOD MANUFACTURING PRACTICES AND PHARMACEUTICAL QUALITY

*Ms. Vaishnavi K. Chivte, Pradnya Dhanraj Mane, Dr. Vijaykumar Manohar Kale, Dr. Mahesh Madhavrao Thakare, Mr. Vaibhav Laxmikant Narwade, Ms. Dhanashree Kiran Chivte

ABSTRACT

Good Manufacturing Practices (GMP) form the foundational framework that ensures the consistent production of safe, high-quality pharmaceutical and food products. As a regulatory system, GMP outlines a set of principles that guide manufacturers in maintaining controlled processes, proper documentation, and rigorous quality assurance across all stages of production. These practices minimize risks that cannot be fully eliminated through final product testing, such as contamination, mix-ups, or deviations caused by human error and poorly maintained facilities. GMP emphasizes the importance of qualified personnel, validated equipment, and well-designed facilities to create an environment where quality is built into every step of manufacturing. A core aspect of GMP is its focus on documentation, which provides traceability, accountability, and transparency. Standard operating procedures (SOPs), batch records, and quality audits ensure that every action is recorded and can be reviewed for compliance. Additionally, GMP requires manufacturers to implement effective quality control and quality assurance systems, including routine inspections, calibration, sanitation, and environmental monitoring. These measures support continuous improvement and help identify potential issues before they impact product quality.

Keywords: Good Manufacturing Practices, Quality Assurance, Quality Control, Quality Management System.