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.
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.
Punyam.com, a leading ISO 15378 Consultant in India, has a vast industrial experience in the implementation of ISO 15378:2017 for all types of pharmaceutical and medicinal products’ primary packaging materials manufacturers. Punyam implements the ISO 15378 certification system for its clients in the following manners:
1 .Micro-level survey for each and every primary packaging materials for pharmaceutical and medicinal products and preparation of a detailed gap analysis report;
2. Preparation of applicable documents as required by ISO 15378:2017 based on the detailed study of all activities for the primary packaging materials, such as:
3 .Preparation of Quality assurance plan for maintaining and assuring quality of inspection services provided to the customer;
4. ISO 15378 training to all levels of employees;
5. Assistance in the effective implementation of the system by periodic visits till accreditation;
6. Conduct internal audit for ISO 15378 system to check readiness for the accreditation;
7. Conduct management review meeting in the presence of Top Management to guide the iInspection bodies for effective implementation on all the concerns related to both management requirements and technical requirements.