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ISO 15378: 2015 consulting service

ISO 15378: 2015, issued in October 2015, is a quality management system for manufacturing industries that supply primary and secondary packaging for the pharmaceutical industry.
ISO 15378 specifies requirements for a quality management system when an organization needs to demonstrate its manufacturing competence to supply pharmaceutical packaging materials. These organizations should show their ability to comply with customer requirements stably, in combination with regulatory requirements and quality measures around the world regarding packaging materials used for medical products.
Thanks to application of ISO 15378: 2015, the benefits of implementing a good manufacturing practices and quality control in the pharmaceutical industry will be easily achieved with reference to good manufacturing practice (GMP). Packaging materials used in the manufacture of pharmaceutical products (such as glass, plastic, aluminum, aluminum ingots, films) directly contact with pharmaceutical products require strict standards to comply product requirements. pharmaceutical products. Suppliers of these packaging materials need to achieve a certain level of quality through the application and implementation of Quality Control Standards and Good Manufacturing Practices in all their manufacturing processes.
ISO 15378 was developed on the national standards and voluntary certification of 03 nations: France, Germany and the United Kingdom; then, get additional ideas from some other countries. The first version was born in 2006. In ISO 15378, the principles of good manufacturing practice (GMP) principles are specified as part of the ISO standard.
Good manufacturing practice (GMP) encourage the companies related to pharmaceutical to eliminate and minimize errors, contaminants and contamination. As a result of that, consumers are protected from purchasing non-guaranteed quality products.
ISO 15378 represents an international consensus about good manufacturing practice principles and creates standards that can be applied in improvement, training, evaluation and quality certification. This standard allows you to perform with legal requirements for pharmaceuticals, cosmetics, medical devices ... as the main packaging material. ISO 15378 combines with ISO 9001, good manufacturing practice principles into one document that designs, manufactures, and supplies starting packaging materials for pharmaceutical products in accordance with international regulations such as those of The Food and Drug Administration (FDA), European and Indian directives.
 In addition, to be suitable with current development trends around the world, the new standard ISO 15378: 2015 provides a guidance on risk management and validation, including an appendix in the both aspect above. This standard applies for all primary packaging materials (such as glass, rubber, plastic, aluminum, etc.).
The ISO 15378 identifies prerequisites for quality management frameworks from the design, manufacture, distribution, tracking to product measurement. It co-orporates criterias for batches and their traceability, controls conditions, validates important methods, manages risks to ensure product efficiency and used time.
It is also applied for international accreditation purposes, and it is seemed as a passport in international as well as domestic markets for factories that have been applying WHO GMP for packaging according to Circular 14 of the Ministry of Health.
Any organization or business unit related to manufacture, distribution, or management packaging materials for medical products may apply ISO 15378. The application is decided by organization, but it is a basis to maintain and increase its level of trust with the customers.
Not only consult on pharmaceutical packaging, KIS also go to consult ISO 15378: 2015 in combination with some specific production requirements for pharmaceutical packages not handled at the request of the Drug Administration of Vietnam. KIS is a professional consultancy company which was proven reputation in the field of providing solutions for pharmaceutical packaging manufacturers in Vietnam when organization want to apply ISO 15378:2015.
No matter which agency or organization certifies, KIS is the best choice for consultancy, training.
To co-operate with KIS, you need to demonstrate your ability to provide quality packaging materials for the pharmaceutical, cosmetics, medical supplies ... industry and to help improve customer’s safety.
Contact us for more detail.
Hotline: 0942 99 66 88 - Email: vphn@kis.vn
 

Translator: Department of Administration

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