ISO 15378: 2017 - Providers of ingredients for use as packaging have been developed to deliver a quality management system (QMS) by stakeholders in the pharmaceutical sector to primary pharmaceutical packaging drugs materials. This international standard classifies the principles of Good Manufacturing Practice (GMP) and specifies the requirements for a quality management system for primary packaging materials for medicines. Implementation of GMP principles for the production and control of primary packaging materials within organizations is of great importance for patient safety from drug use, as it has straight contact with the product. The application of GMPs to pharmaceutical packaging materials confirms that these materials meet the requirements of the pharmaceutical industry.
ISO 15378 Certification is recognized worldwide for 2017 GMP with a global outlook and quality requirements. It delivers manufacturers of basic packaging materials with an appropriate qualification for consumer approval - as well as refining the image of the organization in the eyes of officials. ISO 15378: 2017 applies to all manufacturers of packaging materials in direct contact with drugs. The standard covers all common materials, such as glass, rubber, aluminum and plastic. This standard now aligns with ISO 15378 and has a 10-element high-level structure. ISO 15378: 2017 specifies the requirements for a quality management system when an organization is required to prove its ability to deliver primary packaging materials for drugs that constantly meet customer requirements, with regulatory requirements. And international standard for primary packaging materials.
This ISO 15378: 2017 standard, developed with the contribution of pharmaceutical industry experts, integrates the quality management requirements of ISO 15378: 2015 as well as the principles of Good Manufacturing Practice (GMP) in a single document. For the design, manufacture and supply of primary packaging materials for medicines. The ISO 15378: 2017 standard contains several important QMS guidelines for major manufacturers of glass, plastic, rubber, aluminum, and other materials used for pharmaceutical packaging:
- Compliance with legal requirements.
- Identification, decrease and control of risks with contamination and manufacturing errors.
- Expand efficiency and profitability of operations.
- Process Approach for System Efficiency Monitoring.
- Provision for constant process improvement for complete product and process development.
An ISO 15378:2017 Certification is issued by the Certifying body, which is accredited to deliver the certificate under the ISO 15378:2017 standard. ISO 15378 consultant has a vast industrial experience in the implementation of ISO 15378:2017 for all types of pharmaceutical and medicinal products' primary packaging materials manufacturers. The certificate is issued for the period of 3 years after successful completion of pre-assessment, registration and assessment. The ISO 15378 certification is valid till 3 years from the date of issue.
Steps of ISO 15378 Consultant Service:
- Micro-level inspection for every primary packaging material for pharmaceutical and medicinal products and preparation of a detailed gap analysis report.
- 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 ISO 15378 Quality manual, quality procedures for ISO 15378 certification, standard operating procedures, formats, etc.
- Preparation of Quality assurance plan for maintaining and assuring quality of inspection services provided to the consumer.
- ISO 15378 training to all levels of employees.
- Assistance in the effective execution of the system by periodic visits till accreditation.
- Conduct internal audit for ISO 15378 system to check readiness for the accreditation.
- Conduct management review meeting in the existence of Top Management to guide the inspection bodies for effective execution on all the concerns associated to both management requirements and technical requirements.