ISO 15378:2017 is a standard that sets quality management system (QMS) standards for manufacturers of primary packaging materials for pharmaceutical goods. The standard’s goal is to ensure that pharmaceutical packaging materials fulfil the highest quality, safety, and performance standards.
The standard is intended to assist pharmaceutical businesses in meeting regulatory requirements, such as Good Manufacturing Practice (GMP) for packaging materials, by providing a framework for the development of an auditable and certified QMS. Its primary goal is to assist risk management and the deployment of a controlled system to eliminate these risks to assure the creation of safe products that meet the standards.
ISO 15378:2017 Guideline
ISO 15378:2017 is a quality management system standard that specifies the manufacturing, control, storage, and distribution of principal packaging materials for pharmaceutical products. This standard is intended for suppliers of pharmaceutical packaging materials.
ISO 15378:2017 establishes requirements for primary packaging material producers’ quality management systems (QMS), which include
- Management Responsibilities: The standard specifies top management’s roles and responsibilities in the implementation and maintenance of the QMS.
- Resource Management: The standard specifies standards for managing resources such as staff, buildings, and equipment.
- Product Realisation: The standard specifies the standards for ensuring that packaging materials are manufactured according to client specifications and regulatory requirements.
- Measurement, Analysis, and Improvement: The standard outlines procedures for monitoring and analysing the effectiveness of the QMS, as well as for implementing ongoing enhancement.
Step-by-step Guidelines to Get ISO 15378 Certification
You must complete the following stages to achieve ISO 15378:2017 QMS (Quality Management System) certification:
- Conduct a Gap Analysis: The initial phase is to conduct a gap analysis to identify the areas where your present quality management system does not meet the standards of the ISO 15378:2017 standard.
- Create an Implementation Plan: Create a plan to apply the necessary adjustments to your quality management system based on the results of the gap analysis.
- Implement the Changes: Implement the modifications outlined in the implementation plan, including modifying the procedures, policies, and procedures to meet the requirements of the ISO 15378:2017 standard.
- Conduct an Internal Audit: Perform an internal audit to check that your quality management system meets the standards of the ISO 15378:2017 standard.
- Engage an External Auditor: Employ an external auditor who has been certified by a certification authority to conduct a certification audit of your quality management system.
- Certification Audit: The certification audit will include a review of your quality system’s documents and processes to confirm that they fulfil the standards of the ISO 15378:2017 standard.
- Corrective Actions: If any non-conformities are discovered during the certification audit, remedial action must be taken to resolve them.
- Obtain Certifying: After you have performed and validated the remedial measures, the certifying authority will grant you an ISO 15378:2017 QMS certification.
How can Punyam.com Assist you with ISO 15378 Certification?
Punyam.com is a major ISO Certification Consultant in India, providing advisory services for all ISO standards. Punyam.com, an ISO 15378 consultant in India, can assist you in completing all standards and obtaining ISO 15378:2017 certification.