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ISO 15378 Consultant for Medical Packaging Material Manufacturers

ISO 15378:2017 specifies requirements for a quality management system for the manufacturers of pharmaceutical and medicinal products' primary packaging materials. This process-oriented ISO 15378 certification standard was first published in 2006. It is incorporated in a single document on the basis of the ISO 9001 quality management system requirements together with the Principles of Good Manufacturing Practice (GMP). These requirements and practices are relevant to the design, manufacturing and supply of primary packaging materials for medicinal products. Pharmaceutical and medicinal products primary packaging materials include glass, rubber, plastics, aluminum containers/components, films, foils and laminate containers. As these materials come in direct contact with the medicinal products, they need to comply with the safety, efficacy and reliability requirements. These organizations require demonstrating their capability to constantly meet client requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products. The ISO 15378 standard delineates GMP principles and specifies QMS requirements applicable to the primary packaging materials for medicinal products. Punyam.com, a well-known ISO 15378 consultant in India, can help you in meeting all requirements and achieving ISO 15378:2017 certification.

ISO 15378:2017 Certification

An ISO 15378:2017 Certification is issued by the Certifying body, which is accredited to provide the certificate under the ISO 15378:2017 standard. The certificate is issued for the period of 3 years after successful completion of pre-assessment, registration and (final) assessment. The ISO 15378 certification is valid till 3 years from the date of issue. Surveillance audits are conducted by the Certifying body within the period of 3 years at the interval of 6 months, 9 months or 12 months - depending on the nature and size of the organization. Upon completion of 3 years, a renewal audit is done for the upcoming (new) 3 years' cycle.