Route2Health® has announced that its manufacturing facility situated at Sundar Industrial Estate, Lahore, passed a Good Manufacturing Practice (GMP) audit conducted through the United States Pharmacopeia (USP) GMP Audit Program.
Route2Health® thus became the first nutritional supplement manufacturer in Asia to be awarded this prestigious certificate.
Through the USP GMP Audit Program, Route2Health passed a Good Manufacturing Practice (GMP) audit of its Sundar Industrial Estate facility and quality systems, including quality management, facilities and equipment, material controls, production, packaging and labeling, and laboratory controls.
The Route2Health Sundar Estate facilities, quality systems and processes were reviewed and verified as implementing FDA 21 CFR Part 111 GMPs and USP general chapter <2750> GMPs for dietary supplements.
“USP is pleased to acknowledge that Route2Health has successfully met the requirements of the USP GMP Audit Program,” said Holly Chang, Senior Director USP Technical Services. “This accomplishment demonstrates compliance with the Program’s rigorous standards and a commitment to maintaining a high level of quality at their Sundar Estate facility for manufacturing their products.”
Shahnawaz Baig, MD Route2Health, said: “We pride ourselves on meeting rigorous manufacturing standards. USP’s GMP facility audit program is a testament of assurance to our customers that our products are of international standards. We gauged our robustness by getting thoroughly audited by a globally recognized third-party to provide 100% confidence to our customers.”
Tausif Khan, Chairman Highnoon Laboratories and Route2Health, said: “Patient benefit is the goal whether it be pharmaceuticals or dietary supplements. We operate under an ultra-careful mindset to ensure that our products are safe and efficacious. Sundar Industrial Estate facility’s successful completion of the USP GMP Audit Program is an international affirmation of our quality mindset. We are optimistic that our USP GMP certificate will expedite our geographical expansion.”