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Product Quality

CE Certified

Aurolab, whose main emphasis is on the quality has been certified CE for almost all of its products since 1999. CE marking is mandatory for certain product groups including Ophthalmic products in the European Economic Area (EEA), consisting of the 28 Member States of the EU and EFTA countries Iceland, Norway, Switzerland and Liechtenstein. It not only hold true for the goods that are manufactured in the EU but all goods that are traded in the EEZ. This mark states that the manufacturer of the product has met the EU safety and health and environmental requirements. Aurolab has got its certification in the very next year when the conformance mark is made mandatory. Though Aurolab supplies most of its products to the developing countries like Africa, Latin America, South East Asia where CE Mark is not mandatory, it has exercised this certification to prove the quality standards of products of Aurolab.

US FDA Approved

US FDA (United States Food and Drug administration) is an agency of United States federal executive department.FDA holds the responsibility of protecting and promoting the public health through regulation and supervision of food safety, pharmaceutical drugs, medical devices, cosmetics, etc. Aurolab has got USFDA approval for non- absorbable sutures in 2003.This certificate is provided by inspecting all production plant, Manufacturing process, warehousing and other examinations with the physical sample of the product. The manufacturing facility of Aurolab is built to meet all the standards of USFDA. This divulges the quality standards that are followed in the manufacturing process and the physical products.

WHO GMP STANDARD and EU GMP STANDARD

The Manufacturing facility of Aurolab is built to meet the WHO GMP (World Health Organization Goods Manufacturing Practices) standard, devised by World Health Organization, is a system which ensures that the products are produced and regulated by the quality standards. It eliminates all the risk such as unexpected contamination of drug, incorrect labels on the container/packaging, adverse effect of the drug, level of active content in the drug, etc that are associated with the manufacturing of Pharmaceutical products. Most of countries will prefer to import only those goods that possess WHO GMP standard, which ascertain the quality of the product.

Quality Control Process:

Aurolab has always been focused towards the quality of the products right from the inception. All products of Aurolab undergo 100% Quality check before the final packaging. The organization updates itself with the upcoming quality standard and systems. It has spent huge amount in the quality checking equipments. Thus Aurolab was able to make high quality ophthalmic products that are consumed worldwide.

Our Global Recognitions

Product Certificates

Download FDA - Silk Sutures Certificate

Download FDA - Nylon Sutures Certificate

Download FDA - PGA Sutures Certificate

Download CE Certificate

Download PGA Design Examination Certificate

Download Injector CE Certificate

Quality System Certificates

Download ISO 9001

Download ISO 13485

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