Certification Consultancy Introduces ISO 15378:2017 Documentation Kit for Primary Medicinal Packaging Manufacturers

2026-09-23 10:08:00 Education

Ahmedabad, India, September 23, 2026 — Certification Consultancy has announced its ISO 15378:2017 Documentation Kit, a structured documentation resource designed for organizations involved in the manufacturing of primary packaging materials for medicinal products and working to establish or implement an ISO 15378:2017 quality management system.
ISO 15378:2017 provides quality management requirements for primary packaging materials used for medicinal products. Appropriate documentation helps organizations establish defined processes, responsibilities, controls, records, and quality management practices within their operations.
The ISO 15378:2017 Documentation Kit from Certification Consultancy provides ready-to-use and editable documentation that organizations can modify according to their specific processes, activities, responsibilities, and operational requirements. The documentation is written in plain English and is designed to provide a structured starting point for implementation.
The documentation package includes an ISO 15378:2017 Manual with 8 chapters and 5 annexures, 19 mandatory procedures, 61 standard operating procedures, 43 sample record-keeping forms, 4 sample exhibits, and 12 process approaches with flowcharts. It also includes a department-wise and requirements-wise internal audit checklist containing more than 500 audit questions.
The documentation resources are designed to support organizations in developing and organizing quality management system documentation. The procedures include structured information covering areas such as purpose, scope, responsibilities, implementation methods, reference documents, exhibits, and applicable formats.
The sample forms can be used to establish records across different departments, while the process approaches and flowcharts provide a structured way to document relevant organizational processes. The internal audit checklist can also support organizations in reviewing their implementation and identifying areas requiring attention.
For primary medicinal packaging manufacturers, maintaining organized documentation is an important part of establishing an effective quality management system. The ISO 15378:2017 Documentation Kit provides editable templates that can be reviewed, customized, and adapted to reflect an organization's actual processes and requirements.
The documentation package is intended to help organizations reduce the effort involved in preparing documentation from the beginning. Ready-to-use templates can provide a structured foundation for developing manuals, procedures, SOPs, forms, records, and audit-related documentation.
The ISO 15378:2017 Documentation Kit is particularly relevant to organizations involved in primary packaging materials for medicinal products that are working toward systematic implementation of ISO 15378:2017 requirements and applicable GMP-related practices.
Certification Consultancy provides certification documentation, consultancy, and training services for organizations implementing management systems and accreditation requirements. Its services cover quality, environmental, occupational health and safety, information security, food safety, laboratory accreditation, healthcare, and other management-system requirements.
Organizations interested in learning more about the ISO 15378:2017 Documentation Kit can visit:
https://www.certificationconsultancy.com/iso-15378-certification-documents-manual.htm
About Certification Consultancy
Certification Consultancy is a global consultancy and training company providing certification documentation, management system consultancy, and training services. The company provides documentation and implementation resources for organizations working toward various international management system standards and accreditation requirements.
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Certification Consultancy
Ahmedabad, Gujarat, India
Website: https://www.certificationconsultancy.com/iso-15378-certification-documents-manual.htm