Safety and quality expert TÜV SÜD South Asia has received accreditation from National Accreditation Board for Certifying Bodies (NABCB) to grant ISO 15378:2011 certification to pharmaceutical packaging manufacturers in India.
ISO 15378:2011 sets out the applicable standard for the design, manufacture and supply of primary packaging materials for medicinal products.
TÜV SÜD Central Certification Unit Certification general manager Vibhavari Bhagwat said: “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 help 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 standard allows manufacturers to adhere to international standards set out for primary packaging materials for medicinal products.
The standard also helps to reduce safety hazards and contamination, providing enhanced product efficacy and shelf life.
It sets out the Good Manufacturing Practice (GMP) principles and defines the guidelines for primary manufacturers of glass, plastic, rubber, aluminium and other materials commonly used in medicinal packaging.
Following the accreditation, TÜV SÜD will help manufacturers to meet requirements and enhance production efficiency.
TÜV SÜD South Asia noted that it is among the first certification bodies in India to receive accreditation from NABCB for ISO 15378, ISO 13485, ICMED 9000 and ICMED 13485.