July 25, 2022
(press release)
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As a leading manufacturer of wet wipes in Asia, American Hygienics Corporation (AHC) has been continuously amping up its global compliance efforts to make sure its products meet various rigorous requirements of different markets. The array of compliances AHC follows includes, among others, ISO 13485, ISO 22716, BRC-CP, BPR, cGMP, GMPC and GMP Health Canada. Beyond its FDA compliant medical grade facilities, AHC holds ISO 13485 certification, which is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. The BRC Global Standard for Consumer products, published in 2003 by the British Retail Consortium, aims to protect consumers and to increase the quality and safety of consumer goods through consistent quality- and risk management. In EU, the Biocidal Products Regulation (BPR) refers to Regulation (EU) 528/2012) concerning the placing on the market and use of biocidal products. The key requirement of BPR regulation is that all biocidal products require an authorization by European Chemicals Agency (ECHA) before they can be placed on the EU market, and the active substances contained in that biocidal product must be previously approved. ISO 22716 is the international standard for the Good Manufacturing Practices (GMP) for cosmetics. ISO 22716 provides guidance to documenting and regulating the production, control, storage, and shipment of cosmetic products. In EU, Personal care wipes fall under the category of cosmetics and the European Union’s Regulation (EC) No 1223/2000 requires cosmetic products to be manufactured according to Good Manufacturing Practices (GMP). For North America market, AHC has obtained the U.S. GMPC (Good Manufacture Practice of Cosmetic Products) certificate, the U.S. cGMP (Current Good Manufactured Practice) certificate for its OTC Antiseptic Consumer Hand Rubs and Wet Wipes as well as the GMP Health Canada (Good Manufactured Practices Guide for drug products, GUI 0001) certificate for its OTC Antiseptic Skin Cleansers and Wet Wipes respectively. All these compliances and certifications bear testament to AHC's adherence to the strictest standards to ensure the quality of products with proper design, monitoring, and control of manufacturing processes and facilities. This also involves establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
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