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Zhengli had got ISO 15378 certificate and strictly carry out ISO 15378 standard.
WHAT IS ISO 15378?
ISO 15378:2011 specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organisations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products. The standard delineates GMP principles and specifies QMS requirements applicable to primary packaging materials for medicinal products.
WHY IS IT IMPORTANT?
The ISO 15378 standard enables you to comply with legal requirements for pharmaceutical and medical device primary packaging materials. ISO 15378 integrates the requirements of?ISO 9001 as well as GMP, a regulatory requirement for the pharmaceutical and medical device industries as per all international regulations such as Code of Federal regulations (U.S.), European directives and Indian regulations. Adhering to GMP principles boosts the efficiency of your production processes. The standard also helps to reduce the risks of safety hazards and product contamination, and ensure product efficacy and shelf life.
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