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WHO - GMP Certification

Market Price: ₹3500

World Legal India Price: ₹2500

WHO-GMP Certification ensures pharmaceutical products are consistently produced and controlled to meet quality standards, ensuring safety, efficacy, and compliance with international regulations.

Documents to Submit:

  • Application form for certification

  • Quality management system manual

  • Standard operating procedures (SOPs)

  • Production and process records

  • Equipment calibration and maintenance logs

  • Internal audit and corrective action reports

PDF

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WHO-GMP (World Health Organization – Good Manufacturing Practices) Certification is an internationally recognized standard that ensures medicines, pharmaceutical products, and related substances are manufactured under strict quality control conditions. It emphasizes maintaining hygiene, process control, documentation, and product consistency throughout the manufacturing lifecycle.

The certification process includes evaluating production facilities, equipment, raw materials, personnel practices, and quality management systems. Compliance ensures that products are safe, effective, and of high quality, reducing risks such as contamination, mix-ups, and errors. WHO-GMP also mandates systematic documentation, batch traceability, and continuous monitoring to maintain quality standards.

Obtaining WHO-GMP Certification demonstrates an organization’s commitment to global quality standards, regulatory compliance, and patient safety. It enhances credibility with healthcare providers, regulators, and consumers, while also facilitating access to international markets. Certification encourages continuous improvement, risk management, and adherence to ethical manufacturing practices.

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