How ISA 88 Ensures Compliance in Pharma Manufacturing (FDA, GMP, 21 CFR Part 11)
In pharmaceutical manufacturing, compliance with regulatory standards is critical to ensuring product quality, safety, and traceability. ISA 88, also known as the Batch Control Standard, plays a key role in streamlining batch processing while aligning with regulatory frameworks like FDA regulations, Good Manufacturing Practices (GMP), and 21 CFR Part 11. This article explores how ISA […]










