WHO-GMP

WHO (World Health Organization) Established 7 April 1948 Member 190 country countries WHO  Guidelines on Good Manufacturing Practices (GMP) are a comprehensive set of standards and recommendations developed to ensure the consistent quality of pharmaceutical products. The primary objective of these guidelines is to minimize risks, protect patient health, and ensure the safety, efficacy, and quality of medicines. A WHO GMP Certificate is an official recognition that a pharmaceutical manufacturing facility complies with the World Health Organization’s GMP guidelines, ensuring medicines are safe, effective, and of consistent quality.

GMP is a quality assurance system that ensures pharmaceutical products are consistently manufactured and controlled in accordance with predefined quality standards. These guidelines play a critical role in preventing issues such as contamination, mix-ups, deviations, and incorrect labeling, which could otherwise compromise patient safety.

The WHO GMP guidelines act as a reference and advisory framework for national regulatory authorities (NRAs) and pharmaceutical manufacturers worldwide. They help ensure that medicines are produced under controlled conditions and meet internationally accepted quality requirements.

In India, the Central Drugs Standard Control Organisation (CDSCO) functions as the National Regulatory Authority (NRA) responsible for overseeing and enforcing GMP compliance across pharmaceutical manufacturing facilities.