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
Mumbai, 22 May 2017 : 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.
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.