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ISO 15378:2017 (Rs.5000/-)

Primary Packaging Materials for Medicinal Products

ISO 15378: 2017 - Suppliers of ingredients for use as packaging have been developed to provide a quality management system (QMS) by stakeholders in the pharmaceutical sector to primary pharmaceutical packaging drugs materials.

This international standard identifies 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 direct contact with the product. The application of GMPs to pharmaceutical packaging materials ensures that these materials meet the needs and requirements of the pharmaceutical industry.

ISO 15378: Certification is recognized worldwide for 2017 GMP with a global outlook and quality requirements. It provides manufacturers of basic packaging materials with a suitable qualification for customer approval - as well as improving 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: 2015 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 demonstrate its ability to provide primary packaging materials for drugs that consistently meet customer requirements, including regulatory requirements. And international standard for primary packaging materials.

This ISO 15378: 2017 standard, developed with the participation 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 includes several important QMS guidelines for major manufacturers of glass, plastic, rubber, aluminum, and other materials used for pharmaceutical packaging:

» Compliance with legal requirements
» Identification, reduction and control of risks including contamination and manufacturing errors
» Improve efficiency and profitability of your operations
» Process Approach for System Efficiency Monitoring
» Provision for continuous process improvement for overall product and process improvement

Who Should Get ISO 15378 Certified?

» Any facility offering products or services seeking a generally accepted quality assurance system for primary drug packaging must be ISO 15378: 2017 certified.
» Any installation must assure ISO 15378 certification to assure customers of its quality systems.
» Any facility wishes that the interests of all stakeholders are taken into account in its system and should achieve ISO 15378 certification due to adequate provisions to reduce risk in their processes
» Any installation desiring a powerful marketing tool to present its quality capabilities must obtain ISO certification
» Any facility wishing to have a complete system to cover all aspects of operations in a single management control system must be ISO certified
» ISO 15378 certification is required for any facility whose management aspires to a single system that allows it to provide teamwork, review progress, measure, control, correct and provide the necessary incentives for continuous improvement.

Process for Getting ISO 15378:2017 Certification

» The ISO 15378 certification process begins with the preparation of a quality management system (QMS) for primary pharmaceutical packaging materials
» ISO 15378 consultants assist in the development of a comprehensive quality management system that meets all requirements of ISO 15378 and Phase 1 of the third-party certification body audit. Stage 1 audits of certification bodies vary according to the certification bodies selected, which makes it possible to certify whether the document meets all requirements of ISO 15398.
» An ISO 15378 consulting firm provides implementation techniques and trains the organization's ISO 15378 internal auditors to become proficient to conduct internal processes or provide ISO internal audit services to examine all processes, requirements. Effective application of ISO 15378 and ISO 15378
» Corrective actions should be initiated and continuous improvement achieved through control of non-compliant products / services.
» Institutions should implement a quality management system prepared for at least three months and gather appropriate data and records as evidence.
» Facility management should conduct a comprehensive review of the entire quality management system and ensure its adequacy for its organization. The management team must identify steps to be taken to correct any incomplete ISO requirements
» Once the quality management system is in place, the ISO 15378 internal audit is performed and a full set of management reviews are executed. The establishment should contact the certification body for an ISO 15378 certification audit.
» ISO 15378 certification bodies conduct ISO 15378 audits in two stages. In the first phase, ISO 15378 will evaluate the audit documentation system and the basic requirements to meet ISO requirements.
» The ISO 15378 certification body will return for an ISO 15378 final audit in which all ISO 15378 requirements will be fully audited to ensure compliance with these requirements and the existence of documented evidence of compliance.
» After the ISO 15378 certification body is satisfied, a recommendation is sent to accreditation agencies to issue ISO 15378 certification

The Benefits of Having a QMS for Primary Packaging of Medicinal Products

» Helps organizations in the pharmaceutical industry reduce or eliminate contamination, errors and cases of errors
» Meets mandatory requirements for pharmaceutical packaging manufacturing facilities
» ISO 15378: 2017 aligns with ISO 9001: 2015 and easily integrates standards
» ISO 15378: 2017 certification is an excellent marketing tool to win a share of the international pharmaceutical packaging market.
» ISO 15378: 2017 certification avoids or reduces FDA audit
» An ISO 15378 certified facility can reduce and manage product risk and conduct assumptions