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ISO 15378:2017 Primary Packaging Materials for Medicinal Products

Primary Packaging Materials for Medicinal Products | ISO 15378:2017

The ISO 15378:2017 – Primary Packaging Materials for Medicinal products was developed by stakeholders in the pharmaceutical sector to provide a Quality Management System (QMS) for suppliers of materials intended to be used as packaging for medicinal products.

This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry.

ISO 15378:2017 certification with its holistic approach to GMP and quality requirements, is recognized throughout the world. It provides manufacturers of primary packaging materials with a suitable qualification for customer approval – as well as improving the organization’s image in the eyes of the authorities. ISO 15378:2017 standard applies to all manufacturers of packaging materials that come into direct contact with the medicinal products. The standard covers all the usual materials, such as glass, rubber, aluminum, and plastics.

This standard is now aligned with ISO 15378:2015 and has the same 10 elements high-level structure. The ISO 15378:2017 standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

This ISO 15378:2017 standard, developed with the participation of pharmaceutical sector experts, incorporates in a single document the quality management requirements of ISO 15378:2015 together with the Principles of Good Manufacturing Practice (GMP) for the design, manufacturing, and supply of primary packaging materials for medicinal products.

The ISO 15378:2017 standard includes several important QMS guidelines for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging, including:

  • Compliance to legal requirements
  • Identification, reduction and control of risks including contamination and manufacturing errors
  • Improved efficiency and cost-effectiveness in your operation
  • Process Approach for monitoring effectiveness of the system
  • Provision for Continual Improvement of Processes for overall improvements in products and processes
  • Any facility offering Products or Services and is desirous of having a globally acceptable quality assurance system for primary packaging materials for medicinal products needs to get certified to ISO 15378:2017
  • Any facility desirous of assuring customers about their quality systems should get ISO 15378 standard certification.
  • Any facility desirous of having interests of all stake holders covered in their system and has adequate provisions for mitigating risks in their processes must get ISO 15378 certification
  • Any facility desirous of having a strong marketing tool to showcase their quality capabilities must get ISO certification
  • Any facility desirous of having a complete system which covers all aspects of operations in one single system for management review must have ISO certification
  • Any facility whose management desires to have one single system through which management can build teamwork, review progress, measure, monitor, make corrections and give impetus for continual improvement must get ISO 15378 certification
  • Process of ISO 15378 certification starts with preparation of a Quality Management System (QMS) for primary packaging materials for medicinal products
  • ISO 15378 Consultants assist in developing a comprehensive, QMS to meet all requirements of ISO 15378 and Third-Party Certification Body stage 1 audit ISO 15378 requirements. The stage 1 audit from Certification Bodies vary depending on the selected Certification Bodies which verifies the documented system meeting all ISO 15378 requirements or not
  • An ISO 15378 consulting firm provides the techniques for implementation, and trains organization’s internal ISO 15378 auditors to become competent to perform internal audits or provides ISO Internal Auditing Services to audit all processes, all ISO 15378 Standard requirements and effective implementation of ISO 15378 Standard
  • Facilities need to initiate corrective actions and continual improvement is realized through control of nonconforming products/services.
  • Facilities need to implement the prepared QMS for a minimum of 3 months and gather adequate data and record to show as evidence
  • Managements of the facilities need to conduct one full scale review of the entire QMS and ensure its adequacy for their organization. Management Team needs to identify Action items to make corrections to any ISO requirement not being fulfilled
  • Once a QMS is ready, Internal ISO 15378 audit is performed and one full set of Management review takes place, the facility needs to contact a Certification Body for ISO 15378 certification audit
  • ISO 15378 Certification Bodies conduct ISO 15378 Audit in 2 stages. During Stage 1, ISO 15378 audit will evaluate the documentation system and basic requirements of meeting ISO Requirements
  • ISO 15378 Certification Body will return for final ISO 15378 audit where all ISO 15378 Requirements will be thoroughly audited to ensure that requirements are met and documentary evidence exists to demonstrate compliance
  • Once the ISO 15378 Certification Body is satisfied, recommendation is sent to accrediting agencies to issue ISO 15378 certification
  • QSE Consulting is the practice of assisting small, medium and large organizations in developing, training, implementing, and maintaining a documented Quality Management System (QMS) for achieving ISO 15378 certification
  • QSE Consultants can prepare your facilities to have a Quality Management System (QMS) and associated documents/records to show as evidence of having implemented the system
  • QSE always follows a tried and tested 10 step disciplined path in preparing facilities for ISO 15378 certification, which is insensitive to failure
  • QSE Consultants assist facilities to prepare a comprehensive simplified documentation system to show as evidence of having a streamlined process that ensures quality product or service every time without fail
  • QSE consultants help in identifying issues and concerns of all stake holders and take them in to account in preparing a QMS for ISO 15378 certification
  • QSE assist facilities in matching competence of personnel assigned to tasks, methods to select providers who supply quality products and services
  • QSE Consultants assist to build a robust system which compels task performers to have defined roles, responsibilities and controls to ensure quality
  • QSE Consultants assist organizations to identify all manufacturing and nonmanufacturing processes and facilitate in establishing process performance metrics or process performance indicators (Key Process Indicators = KPIs) to effectively monitor and measure organizations intended Goals and Objectives
  • QSE Consulting services are required to assist organizations in building a comprehensive QMS to identify risks at every process and have steps to mitigate risk
  • Internal Quality Audits conducted by QSE consultants, help the facilities to find all deficiencies in their implementation which are not normally found during organizations first party audits
  • QSE Consultants assist in meeting “Annex SL, a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written.” which in turn meets ISO 15378 requirements
  • QSE Consultants provide training to top management in promoting Risk-Based Thinking, Process Approach, and Continual Improvement
  • QSE consultants assist organizations to effectively control document information (Documents and Records) related to changes, conducting ISO management review meetings covering all management review inputs (as per ISO 15378 requirements)
    Including the trends to be monitored, internal audit results are fully addressed, risk related activities identified/assessed/mitigated, root-cause, identified and analysis is fully applied.
  • QSE consultants will ensure that certification is achieved with no or minimum nonconformities first time around
  • QSE is a premier Consulting, Auditing, and Training firm engaged in the field of ISO 15378 certification to international standards
  • QSE has a unique 10 steps disciplined path for ISO 15378 certification which is insensitive to failure
  • QSE has assisted over 700 facilities achieve ISO certifications
  • QSE’s unique document simplification tools result in smooth   implementation to achieve ISO 15378 certification
  • QSE identifies all processes from “Quote to Cash” in other words all activities from submission of quote, processing of the order, quality control, dispatch to customer and receive cash. All manufacturing and non-manufacturing processes are covered
  • QSE’ s documentation covers all requirements of customers and other interested parties, statutory and regulatory requirements
  • QSE’s unique simplified documented system is easy to integrate to other management systems
  • QSE engages qualified and competent auditors to conduct internal audits
  • QSE’s internal audits are more stringent than ISO 15378 Certification Bodies audits and will help companies pass certification audits with minimum nonconformities or no nonconformity
  • 98% of QSE assisted facilities passed the initial certification audit with zero deficiencies with a 100% passing rate first time around
  • QSE covers all the requirements of the standard including the implicit intent of the standard
  • QSE’s system development involves all relevant employees which lead to effective implementation
  • QSE’s Document Simplification is unique comprehensive single level documentation which ensures effective implementation
  • QSE’s documentation is unique, simple, lean and easy to implement and sustains certification audits in the long run
  • QSE’s ISO 15378internal auditing services promote the unbiased assessment of QMS implementation and the extent of implementation
  • QSE ensures to provide implementation assistance or complete understanding of the documentation and requirements
  • QSE’s unique management review format results into no nonconformities against management review during certification audits
  • QSE does not simply tell our customers what to do but assists them on how to do 
  • QSE’s 10-step disciplined path for ISO 15378 certification, achieves the organizations certification in the shortest possible time. Usually within 5 months
  • QSE provides post auditing services if required and can take the disputes to the highest levels for resolution

The benefits of implementing ISO 15378 management systems are diverse and seen in all departments of a given company. 

The benefits of certification:

  • Helps organizations in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors
  • Meets mandatory requirements for facilities engaged in manufacturing packaging for medicinal products
  • ISO 15378:2017 aligns with ISO 9001:2015 and easily integrates both the standards
  • ISO 15378:2017certification is a great marketing tool to get international market share of packaging of medicinal products
  •  ISO 15378:2017 certification avoids or minimizes FDA audits
  • An ISO 15378 certified facility can minimize and managing product-related risk and conducting validation activities 

QSE has assisted over 700 organization in obtaining ISO and other certifications, contact details can be furnished on demand for any certification

Primary Packaging materials for medicinal products are very important items and are directly linked to the health and wellbeing of humans or animals consuming those medicinal products. FDA attached great importance to this packaging materials affecting health. To minimize or eliminate FDA audits, it is advisable to get ISO 15378 certification.

Third-Party audit ISO 15378 Certification Bodies (accredited by the International Accreditation Forum or IAF) perform the audits on the organizations to grant ISO 15378 certifications with demonstrated evidence of conformity to all the requirements of ISO 15378:2017.

Typically, it takes anywhere between 7 to 8 months for certification when you start from scratch. QSE has well developed systems and ISO 15378 templates which are easily understood for implementation. Therefore, it is possible to get certification within about 5 months through QSE.

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