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Нормативно-правовая помощь

Lonza has the in-house expertise for making sure we meet regulatory standards for healthcare products anywhere in the world. In addition to our regulatory expertise, our quality assurance managers have extensive experience in the nutrition market.
Нормативно-правовая помощь

Соответствие стандартам в глобальном масштабе

Если вам необходимо быстро реагировать на изменяющийся глобальный спрос, осваивать новые или развивающиеся рынки для сохранения конкурентоспособности, наши знания в области обеспечения соответствия нормативным требованиям помогут вам достичь поставленных целей.

Lonza Capsules & Health Ingredients’ products and manufacturing facilities conform to the highest worldwide quality and regulatory standards:

Стандарты продукции

Only pharmaceutical and food grade gelatin is utilized in ® brand capsules, enabling our capsules to meet food and Pharmacopoeia standards
Lonza provides confidential detailed information about facilities, processes, articles used in manufacturing, processing, packaging, and storing of empty capsules through Type IV (Excipient) Drug Master Files submitted to the Food and Drug Administration in the U.S. and Type III (Excipient) Drug Master File submitted to Health Canada
We manufacture gelatin capsules from gelatin that complies with bovine spongiform encephalopathy (BSE) requirements
Capsugel® Vcaps® capsules, Vcaps® Plus capsules, DRcaps® and Plantcaps® capsules are made of plant origin, are Kosher and Halal certified, do not contain any GMO’s, and are approved by the Vegetarian Society
Безопасность пищевых продуктов, пищевых добавок и фармацевтических продуктов привлекает особое внимание потребителей, правительств и продовольственной промышленности. As such we mitigate risks through a comprehensive quality control and assurance program not only making good business sense, it can actually lead to a reduction in costs for testing as well as savings in both fixed and variable costs.

Стандарты производственных процессов и соответствие нормам ISO

Capsugel® capsules are manufactured under controlled climate conditions in accordance with applicable cGMP standards, using a dipping process on high-capacity automatic machines
Печать на предварительно закрытых капсулах, при желании заказчика, производится до этапа окончательной упаковки капсул
Due to the high quality of its manufacturing conditions, Lonza, does not use any preservatives, irradiation or ethylene oxide for preventing or eliminating microbial growth
All Capsugel® two-piece capsule manufacturing facilities have met the requirements for ISO (International Standards Organization) registration

Поскольку законы и постановления зависят от страны и часто применяются по факту нарушения, обращайтесь к нам за подробной информацией, относящейся к производственному процессу изготовления наших капсульных продуктов. And as always, we strongly suggest you seek your own expert regulatory advice.


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