MUMBAI, June 22, 2017 /PRNewswire/ --
- ISO 15378:2011 focuses on primary packaging materials for medicinal products, with reference to Good Manufacturing Practices
- TÜV SÜD South Asia has been awarded the accreditation for ISO 15378:2011 by NABCB
Globally acclaimed German safety and quality expert TÜV SÜD, today, received accreditation from National Accreditation Board for Certifying Bodies (NABCB) to grant ISO 15378:2011 certification to manufacturers of primary packaging materials for pharmaceuticals and medical devices. ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. TÜV SÜD is the first independent certification body in India accredited by NABCB to issue this certification.
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The ISO 15378:2011 standard enables manufacturers to comply with international standards applicable to primary packaging materials for medicinal products. It also helps reduce the risks of safety hazards and product contamination, and ensures product efficacy and better shelf life. TÜV SÜD offers auditing and certification services to support manufacturers of primary packaging materials in addressing specific requirements to meet the quality objectives specified by ISO 15378.
Commenting on the accreditation, Ms. Vibhavari Bhagwat - Senior General Manager, Certification, Central Certification Unit said, "It is an honour for us to be the first certification body in India accredited by NABCB for ISO 15378:2011. Packaging materials form a very important part of the entire value chain for medicines. Along with our global experts, we will assist manufacturers in improving production processes, optimise cost and reduce the risks and defects by adhering to the guidelines. TÜV SÜD will also support the pharmaceutical and medical device industries to assess suppliers of primary packaging materials and increase overall product quality, thus enabling them to develop business excellence and protect the end consumer."
The ISO 15378:2011 defines GMP (Good Manufacturing Practice) principles and specifies a number of important QMS guidelines for primary manufacturers of glass, plastic, rubber, aluminium and other materials used for medicinal packaging. TÜV SÜD supports manufacturers in meeting these guidelines by adhering to GMP principles to boost the efficiency of the production processes.
TÜV SÜD South Asia was also among the first certification bodies in India to receive accreditation from National Accreditation Board for Certifying Bodies (NABCB) for ISO 15378, ISO 13485, ICMED 9000 and ICMED 13485.
Further information is available at http://www.tuv-sud.com.
About TÜV SÜD
TÜV SÜD is a leading international service organisation catering to the strategic business segments industry, mobility and certification. Headquartered in Munich, Germany and founded in 1866, it has over 24,000 employees representing more than 850 locations throughout the world. Optimising technology, systems and know-how, the interdisciplinary specialist teams act as process partners to strengthen their customers' competitiveness.
About TÜV SÜD South Asia
TÜV SÜD South Asia is the leading consulting, testing, inspection and certification (TIC) company with presence across India, Bangladesh and Sri Lanka. With more than 1300 employees, TÜV SÜD South Asia has serviced over 10,000 clients to date through the past two decades. It is present at 32 locations including 19 labs across the three countries. Today, TÜV SÜD South Asia is internationally competent to provide TIC solutions cutting across a wide range of sectors that include management systems, conventional and renewable energy, water, sanitation, environmental technology, infrastructure, transit systems, real estate, food, supply chain, agriculture, toys, consumer electronics, textiles, leather and related products, automobile and components, and technical as well as soft-skills training.
For further details visit http://www.tuv-sud.in/
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