ISO 15378

The ISO 15378:2017(Primary Packaging Material for Medical Products) standard specifies particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) requirements, applicable to primary packaging materials for a quality management system (QMS) where an organization needs to demonstrate the ability to provide primary packaging materials for medicinal products that consistently meet customer and regulatory requirements as well as international best practice. ISO 15378 is applicable for the design, manufacture and supply of primary packaging materials for medicinal products; the standard is generic and intended to be applicable to any organization, regardless of its type or size, or the products and services it provides

The ISO 15378 Primary Packaging Materials for Medicinal standard 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. When you certify your operation against the ISO 15378 standard, you mitigate your risks especially related to contamination, mix-ups and errors. Further, you ensure your customers of the compliance of your QMS.

The ISO 15378 Primary Packaging Materials for Medicinal standard was developed by stakeholders in the pharmaceutical sector to give a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products.

ISO 15378:2017 Certification outlines requirements for a quality management system specifically tailored for the manufacturing of primary packaging materials for medicinal products. This certification ensures that organizations meet regulatory and quality standards, enhancing the safety and efficacy of pharmaceutical packaging. By achieving ISO 15378 certification, companies demonstrate their commitment to quality, compliance with applicable regulations, and continuous improvement in their manufacturing processes.

Descriptions: ISCC Certification Service Description Brief ISCC Certification Services encompass a range of services aimed at ensuring the sustainability, traceability, and integrity of raw materials and products across supply chains. These services include: Guidelines and Instructions: Providing detailed guidelines and instructions for certifications and their requirements.

ISO 15378:2017 - PRIMARY PACKAGING MATERIALS FOR MEDICAL DEVICES SO 15378:2018 specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organizations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products. The standard delineates GMP principles and specifies QMS requirements applicable to primary packaging materials for medicinal products. The ISO 15378 standard enables you to comply with legal requirements for pharmaceutical and medical device primary packaging materials. ISO 15378 integrates the requirements of ISO 9001 as well as GMP, a regulatory requirement for the pharmaceutical and medical device industries as per all international regulations such as the Code of Federal Regulations (U.S.), European directives, and Indian regulations. Adhering to GMP principles boosts the efficiency of your production processes. The standard also helps to reduce the risks of safety hazards and product contamination, and ensure product efficacy and shelf life. Our certification services empower businesses to achieve their goals through expert guidance, establishment consultancy, implementation, and training, ensuring alignment with both government and private certification bodies. With a global vision and a local focus, Shamkris Global Group is dedicated to supporting your business in successfully navigating the complex regulatory and certification landscapes.

Training Programme Features ISO 15378:2017 (GMP Good Manufacturing Practices) is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.Good Manufacturing Practice (GMP) is a term that is renowned worldwide for the control and management of manufacturing, testing and final quality control of food / beverage, pharmaceutical goods and their primary packaging. GMP is a set of rules that gives you the affirmation that your item is safe. GMP is responsible for the safety, efficiency and quality of pharmaceutical products, cosmetic products, edible products and their primary packaging.This Training Programme introduces participants to ISO 15378 and gives an overview of new requirements & its interpretations. The Training Programme is useful for all the organizations / personnel to develop an effective management system with reference to Good Manufacturing Practices (GMP) for Primary Packaging Materials of Medicinal Products. Who should attend the training? Quality Managers / ExecutivesManagement RepresentativesManagement System ConsultantsPersonnel wishing to attend Internal or Lead Auditor Training Programme Training Coverage Introduction to ISO 15378Overview of Revision HistorySystem designating and PlanningRequired DocumentationOperational Planning & ControlPerformance EvaluationImprovementEnd of Training Programme

ISO Certification ConsultancyWe assist in implementation, documentation, training, and certification for the following ISO standards: ISO 9001 Quality Management System ISO 13485 Medical Devices Quality Management ISO 14001 Environmental Management System ISO 45001 Occupational Health and Safety ISO 22000 Food Safety Management ISO 27001 Information Security Management ISO 21001 Educational Organization Management ISO 50001 Energy Management System ISO 17025 Laboratory Accreditation GMP / WHO-GMP / CE Marking Documentation SOP DevelopmentQMS Manuals, Procedures, SOPs, Work Instructions Risk Assessments, CAPA systems, Internal Audit Tools Training ServicesISO Awareness Programs Internal Auditor Training Lead Auditor Training Customized corporate training modules Audit SupportGap Analysis Mock Audits Internal Audit Services Certification Body Coordination Why Choose Us? 100% Certification Success Rate Quick Cost-Effective Solutions Experienced Certified Consultants Industry-Specific Knowledge Confidential Ethical Practices On-time Project Completion

A specialized certification for manufacturers of glass, plastic, or rubber packaging for the pharma industry. We help you integrate ISO 9001 requirements with GMP (Good Manufacturing Practices) to ensure zero-defect packaging.

What is ISO 15378:2017 Certification This standard specifies particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) requirements, applicable to primary packaging materials for a quality management system (QMS) where an organization needs to demonstrate the ability to provide primary packaging materials for medicinal products that consistently meet customer and regulatory requirements as well as international best practice. It is applicable for the design, manufacture and supply of primary packaging materials for medicinal products; the standard is generic and intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. Advantages: Demonstration of quality, good manufacturing and safety controls: This standard testifies to the achievement of the principles of Good Manufacturing Practices and the control of primary packaging items within organizations; very important for the safety of a patient using the drug given its direct contact with the product. The application of Good Manufacturing Practices for pharmaceutical packaging products should ensure that they meet the needs and requirements of the pharmaceutical industry. Alignment with ISO 9001:2015 specific to medicinal product packaging: This International Standard is an application standard for primary packaging articles that contains the full text of ISO 9001:2015, which allows certified organizations to optimize the implementation of the requirements of ISO 9001 for the manufacture of primary packaging materials for medicinal products Brand Protection: This certification helps assure your organization s commitment to quality and safety, helping to improve and protect your brand and organizational image, both publicly and with key stakeholders Risk management: This certification is designed to help organizations identify, control and manage risks throughout the ISO 15378 audit process Regulatory compliance: This certification supports your organization s efforts to maintain current and anticipated future compliance with applicable statutory and regulatory requirements Customer satisfaction: This certification is designed to help enhance customer satisfaction through the effective application of the QMS, including processes for continual improvement and assurance of conformity to customer requirements Structure Introduction 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement Annexure A: Clarification of new structure, terminology and concepts B: Other international standards on quality management and quality management system developed by ISO/TC 176 C: GMP requirements for printed primary packaging materials D: Guidance on verification, qualification and validation requirements for primary packaging materials

CDG is a trusted provider of ISO 15378:2017 Certification Services in India, helping pharmaceutical packaging manufacturers implement internationally recognized quality management systems for primary packaging materials. ISO 15378:2017 integrates the requirements of ISO 9001 with Good Manufacturing Practices (GMP) specifically for manufacturers of primary packaging materials used in medicinal products. This certification demonstrates a company s commitment to product quality, patient safety, regulatory compliance, and continual improvement in pharmaceutical packaging operations. Our ISO 15378 certification consultancy services are designed for manufacturers of glass containers, rubber closures, plastic packaging, aluminum caps, blister packs, pharmaceutical bottles, vials, ampoules, tubes, cartons, and other primary packaging materials used in the pharmaceutical industry. CDG provides complete support for ISO 15378 implementation, documentation, training, internal audits, gap analysis, GMP compliance, risk management, and certification assistance across India. ISO 15378:2017 certification helps organizations establish a robust Pharmaceutical Packaging Quality Management System (PPQMS) that meets the expectations of pharmaceutical companies, global buyers, and regulatory authorities. With increasing demand for GMP compliant packaging suppliers, ISO 15378 certification has become essential for businesses involved in pharmaceutical primary packaging manufacturing and supply chains. CDG offers professional ISO 15378 consultancy services for small, medium, and large pharmaceutical packaging manufacturers. Our experienced consultants guide organizations in meeting all ISO 15378 requirements including process control, contamination prevention, traceability, validation, documentation control, quality assurance, hygiene practices, risk assessment, supplier management, and customer satisfaction monitoring. Benefits of ISO 15378:2017 Certification include improved product quality, enhanced GMP compliance, reduced manufacturing risks, better process efficiency, increased customer confidence, improved market reputation, international business opportunities, and compliance with pharmaceutical industry standards. ISO 15378 certification also helps organizations strengthen regulatory compliance and improve operational consistency in pharmaceutical packaging production. Our ISO 15378 certification process includes: ISO 15378 gap assessment GMP compliance evaluation Documentation development SOP preparation Quality manual preparation Employee training Internal audit support Corrective action implementation Certification audit coordination Post-certification support CDG provides ISO 15378 certification services in Delhi, Mumbai, Pune, Bengaluru, Hyderabad, Chennai, Ahmedabad, Kolkata, Noida, Gurugram, Faridabad, Chandigarh, Baddi, and all major industrial cities across India. We work with pharmaceutical packaging manufacturers, medical packaging companies, packaging material suppliers, pharma container manufacturers, and healthcare packaging industries. If you are searching for ISO 15378 Certification in India, ISO 15378 consultants, ISO 15378 certification cost, ISO 15378 GMP certification, pharmaceutical packaging certification, ISO 15378 audit services, ISO 15378 implementation services, GMP for pharmaceutical packaging, primary packaging material certification, pharmaceutical packaging quality management certification, or ISO 15378 consultancy services in India, CDG is your reliable certification partner. Our team ensures a smooth, cost-effective, and timely ISO 15378 certification process tailored to your organization s operational requirements.

Certification and consultancy both, onsite training and assessment and reporting .

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Amatya Solutions Private Limited Company (A Unit of Amatya Group) Provides Iso 15378 2017 Certification Service ISO 15378 is a standard for the primary packaging materials for medicinal products. It specifies requirements for the design and manufacturing of primary packaging materials, such as glass, plastics, elastomers, and aluminum, used in the pharmaceutical and healthcare industries. These materials are essential to ensure the safety and quality of pharmaceutical products. ISO 15378:2017 is a specific version of the standard that was published in 2017. It outlines the requirements for the quality management system of manufacturers of primary packaging materials for medicinal products. To achieve ISO 15378:2017 certification, a manufacturer must demonstrate compliance with these requirements. The certification is a way of showing that the manufacturer follows good manufacturing practices and is committed to producing high-quality packaging materials for pharmaceutical products. If you are looking for ISO 15378:2017 certification services, you would typically need to contact a certification body or registrar accredited by an authoritative organization. These certification bodies assess and audit the quality management systems of manufacturers to determine if they meet the ISO 15378:2017 requirements. If the manufacturer complies, they receive ISO 15378:2017 certification. To find a certification service provider, you can search for accredited certification bodies in your region or contact a relevant industry association for recommendations. Keep in mind that ISO certification typically involves a thorough audit and assessment process to ensure compliance with the standard's requirements.

ISO 15378 is an international standard that specifies the requirements for a Quality Management System (QMS) for organizations involved in the design, manufacture, and supply of primary packaging materials for medicinal products. The standard integrates the requirements of ISO 9001:2015 with Good Manufacturing Practices (GMP) to ensure that packaging materials consistently meet customer, statutory, and regulatory requirements. The current edition is ISO 15378:2017, confirmed in 2023, with Amendment 1:2024 introducing climate-action-related changes. Objective The objective of ISO 15378 is to: Ensure the safety and quality of primary packaging materials for medicinal products. Integrate Quality Management System requirements with GMP principles. Prevent contamination, mix-ups, and manufacturing defects. Enhance product traceability and regulatory compliance. Improve customer satisfaction through continual improvement. Scope The standard applies to organizations involved in: Design and development Manufacturing Printing and decoration Testing and inspection Storage and distribution of primary packaging materials that come into direct contact with medicinal products. Examples of Primary Packaging Materials Glass vials and ampoules Plastic bottles and containers Rubber stoppers and closures Aluminum caps and seals Blister films and foils Prefilled syringe components Plastic tubes Pharmaceutical closures and dispensing systems Major Requirements of ISO 15378 Quality Management System based on ISO 9001:2015 Good Manufacturing Practices (GMP) Risk-based thinking and quality risk management Product realization and process validation Change management and change control Supplier qualification and evaluation Raw material control Traceability of materials and finished products Contamination prevention and cleanliness Infrastructure and work environment control Equipment calibration and maintenance Personnel competency, training, and hygiene Documentation and document control Record retention Internal audits Management review Corrective and Preventive Action (CAPA) Customer complaint handling Continual improvement Key GMP Elements Prevention of contamination and cross-contamination Controlled production environment Material identification and segregation Cleaning and sanitation procedures Validation of critical manufacturing processes Packaging material protection during storage and transportation Product recall and traceability system Benefits of ISO 15378 Certification Demonstrates compliance with pharmaceutical industry expectations. Improves product quality and consistency. Reduces risks of contamination and packaging defects. Strengthens supplier credibility and customer confidence. Supports compliance with global pharmaceutical regulations. Improves operational efficiency and process control. Reduces customer audits through internationally recognized certification. Enhances market access in domestic and international pharmaceutical industries. Organizations That Should Implement ISO 15378 Pharmaceutical packaging manufacturers Glass container manufacturers

ISO 15378:2017 Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) specifies requirements for a QMS when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, with the goal of enhancing customer satisfaction through effective systems, continuous improvement, and commitment to customer and applicable statutory and regulatory requirements. It is applicable to any organization, regardless of its type or size, or the products and services it provides. ISO 15378:2017 s GMP principles in production and control of primary packaging materials are important for the safety of a patient receiving the medicinal product because of the direct contact between the packaging materials and the product. ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. ISO 15378:2017 provides two very useful normative annexes: Annex C (normative) GMP requirements for printed primary packaging materials Annex D (informative) Guidance on verification, qualification, and validation requirements for primary packaging materials

Iso 15378 Specifies Quality Management System Requirements for Primary Packaging Manufacturers in the Pharmaceutical and Medical Device Industries, and Benchmarks Their Ability to Consistently Deliver Safe and Reliable Packaging.

This 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.ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.BenefitsMinimize or eliminate instances of contamination, mix-ups, and errors.Reassure business partners and customers of commitment to qualityProtect customers from purchasing potentially ineffective or dangerous productsProduction and service cost is reduced to lot extent.Services become more effective and efficient in all mannersImproved legal and regulatory or contractual requirements complianceThorough traceability of material as well as finished product is maintainedStandard of safety throughout the organization is upliftedOperating cost is reduced by reducing or eliminating down time in terms of health concernsCompliance with legal, statutory and regulatory requirementsImproved stakeholder relationships - by safeguarding the human health and propertyReputation of organization is improved in societyImproved risk management by making people aware about health and safety related issuesBusiness sustainability is increased

Product Description ISO 15378:2011 specifies needs for a quality management system where an organization requirements to demonstrate its ability to provide primary packaging materials for medicinal products, which constantly meet client needs, including regulatory necessities and International Standards applicable to primary packaging materials. ISO 15378:2011 is an application standard for the design, manufacture and provide of primary packaging materials for medicinal products. It is also applicable for certification purposes. Benefits of ISO 15378:2011 Decrease in mistaken mix-ups Decrease of manufacturing errors Minimization or elimination instances of contamination Creates competitive advantages Cost minimization for certified organization Confirmation of adherence to legal needs and contractual obligations Additional assurance of quality products to your clients Decrease and control of risks Saves time and costs Obvious statement of the organization s competence Get better quality capability

ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.ISO 15378 requirements include compliance to ISO 9001 and Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials 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.Good Manufacturing Practice (GMP) is a term that is renowned worldwide for the control and management of manufacturing, testing and final quality control of food / beverage and pharmaceutical goods and their primary packaging. GMP is a set of rules that gives you the affirmation that your item is safe. GMP is responsible for the safety, efficiency, and quality of pharmaceutical products, cosmetic products and edible products and their primary packaging.The quality approach of GMP guarantees to enable organizations to limit or eliminate instances of contamination, mistakes and errors. This thus shields the customer from purchasing an item, which isn t effective or even dangerous. It is accepted that GMP is one of the best business tools, which will refine both the compliance and performance of the organization.ISO 15378 being a specific standard for primary packaging materials for medicinal products, the required controls and monitoring of the quality management system and actual on floor practices are very specific and stringent. In such scenario, the practical, easy and effective implementation of the system is very essential. PQSmitra team with an expertise more than 20 years has supported many clients implement GMP and get ISO 15378 certification.The ISO 15378:2017 implementation process is described below: Review of the existing Quality Management System. This review is carried out through discussions and verifications of records during visits to the client organization. The pharma customer specific requirements are taken into consideration to make this activity effective.GMP based system designing and documentation (Records and Procedures). 100% documentation support is offered by PQSmitra. This includes shop floor controls as well as control on documentation and records.Training on GMP and QMS related requirementsRoutine assistance and system verification to ensure compliance to the requirements.Internal audit and Management reviewCertification audit Stage 1 and Stage 2Submission of action plan on audit observationsReview of report by the certification authority and awarding the certificate to the organization

ISO 15378 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. All the requirements of ISO 15378 standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. ISO 15378 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.QGlobal is the leading management consultants providing end to end consulting services for businesses to obtain ISO 15378 certification. We have proven track record of providing ISO 15378 certification consultancy services at very competitive price. With our immense experience in offering ISO 15378 certification consultancy services, we can understand your challenges in a better way and provide you the most comprehensive services. Depending upon your requirement, we can provide you end to end support for successfully implementing ISO 15378 standard to achieve certification.Benefits of ISO 15378 certification Better communication Increase customer loyalty and customer retention Improve customer focus and satisfaction Build brand reputation Continual improvement Good governance & leadership Increase employee morale and productivity Standout among competition Manage process risks Adaptability to changing regulatory requirements Eliminate defects and waste Adaptability to changing customer perceptions Reduce customer complaints and rework Worldwide recognition and credibility

ISO 15378:2015 identify necessities for a quality management system where an organization requirements to demonstrate its capability to give primary packaging materials for medicinal products, which constantly meet client necessities, including regulatory necessities and International Standards applicable to primary packaging materials.Benefits of ISO 15378:2015 Certification Decrease and control of risks Presentation of the company's expertise Creation of competitive advantages Time and cost savings Evidence of compliance with statutory regulations and contractual agreements Development of the quality ability

ISO 15378 Certification Services

Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP). It 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. ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

ISO 15378 Certification Services

The ISO 15378 Primary Packaging Materials for Medicinal standard was developed by stakeholders in the pharmaceutical sector to give a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products. ISO 15378:2011 identifies needs for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organizations require demonstrating their capability to constantly meet client necessities, including regulatory requirements and global standards applicable to primary packaging materials for such medicinal products. The standard delineates GMP principles and specifies QMS necessities applicable to primary packaging materials for medicinal products. CANDCERT is an internationally acknowledged leader in certification for the pharmaceutical sector. The CANDCERT worldwide network of auditors understands you re manufacturing procedures and the accurate meaning of all aspects of the standard. The ISO 15378:2006 standard includes a number of essential QMS guidelines for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging. Benefits of ISO 15378 Certification Decrease of manufacturing errorsAdditional assurance of quality products to your clientsCost minimization for certified organizationDecrease in mistaken mix-upsEnhancement in processesMinimization or removal instances of contamination

GMP has been restated as a legal requirement in order to ensure the health of consumers by reducing risk, including contamination and/or mix-ups, in the pharmaceutical and food industries.First published in 2006, the process-oriented ISO 15378 standard focuses on this perspective. Based on the internationally accepted ISO 9001 quality standard, it contains all of the GMP requirements relevant to primary packaging material, such as batch tracing, risk management, validation, and controlled environment. ISO 15378 applies to all manufacturers of packaging materials that come into direct contact with the medicinal product, e.g. glass, rubber, aluminium, and plastics.ISO 15378 benefitsA certificate to ISO 15378, with its holistic approach to GMP and quality requirements, is recognized throughout the world.Evidence of adherence to legal requirements and contractual obligationsReduction and control of risksClear statement of the organization s competenceCreates competitive advantagesImproves quality capabilitySaves time and costs Conformity and value generationDQS was the first certification body to become accredited for ISO 15378 by the German Association for Accreditation (TGA) in July of 2007. With an independent and expert assessment of their management system, top management can be sure that the system is in conformance with the requirements of the standard. In addition, the auditors will focus on the identification of improvement potential. Finally, audits also result in an increased awareness of whether or not the management system is suitable for achieving the desired results. With value-generating audits, the ideal certification body will provide direction for decision making processes.

ISO 15378:2015 specifies requirements for a quality management system where an organisation needs to demonstrate it's 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