Topic: Glp

Microbiology

Enhancing Microbial Oversight in Non-Sterile Pharmaceutical Manufacturing

Microbial management is vital in non-sterile pharmaceutical manufacturing to prevent contamination and ensure product safety. Effective control strategies include risk-based product development, supplier qualification, and rigorous environmental monitoring.

July 28, 20265 min read

GMP

Understanding the Essentials of 21 CFR Part 11 in Pharmaceutical Laboratories

21 CFR Part 11 establishes requirements for electronic records and signatures in pharmaceutical laboratories, ensuring data integrity and compliance. It mandates system validation, automated audit trails, and security measures to protect electronic data generated by laboratory instruments.

July 27, 20267 min read