ISO 15378:2017 is a standard that specifies the standards for the manufacture, packing, and storage of principal packaging materials for pharmaceutical products. The standard is intended to ensure that primary packaging materials are created and handled in a manner that fulfils the pharmaceutical industry's exacting requirements. It is also meant to ensure that these materials are of the highest quality and satisfy the unique needs of the pharmaceutical sector.
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 construction of a QMS that can be audited and certified.
What is ISO 15378:2017 Certification?
ISO 15378:2017 is a Quality Management System (QMS) certification standard that outlines the standards for pharmaceutical main packaging materials. The standard focuses on Good Manufacturing Practices (GMP) and guaranteeing the safety, quality, and consistency of drug-making components.
The ISO 15378:2017 standard establishes guidelines for the design, development, manufacturing, and distribution of pharmaceutical packaging components such as containers, closures, and labels. The standard also contains risk management, quality control, and documentation requirements.
Pharmaceutical packaging manufacturers can demonstrate their dedication to delivering high-quality products that comply with industry laws and meet consumer expectations by acquiring ISO 15378:2017 certification.
What are the Advantages of ISO 15378:2017?
- The ISO 15378:2017 Standard includes strategic instruments for lowering costs by reducing waste and manufacturing errors while enhancing productivity.
- It encourages businesses to enter new markets and promotes free and fair global trade.
- Manufacturers can improve their manufacturing processes by adhering to GMP standards by the ISO 15378:2017 certification
- To reduce your risks, particularly those associated with product contamination, mix-ups, and errors, and to assure product efficacy and shelf life.
- Clients can be assured of high-quality items. Improve customer satisfaction.
- Competitive advantage over other service providers.
- The use of risk management aids in the reduction of product faults.
Application of ISO 15378:2017
- ISO 15378:2017 is an application standard for the design, manufacture, and supply of primary packaging material for pharmaceutical products.
- It is also ideal for the certification of principal packaging material for medicinal items in the pharmaceutical and medical device industries. This primary packaging standard identifies good manufacturing practice (GMP) norms and Quality Management systems applicable to primary packaging materials for pharmaceutical goods.
- ISO 15378:2017 can be used for quality improvement, training, auditing, and certification.
- Every five years, the ISO 15378:2017 certification standard is reviewed.
Requirements of ISO 15378:2017
The following sections define ISO 15378 requirements:
- Organizational context
- Leadership
- Make a plan.
- Help
- Operation (extra BPM needs)
- Performance evaluation
- Development
How will Certificationconsultancy.com Help to Achieve ISO 15378 Certification?
We provide an ISO 15378 certification consulting for primary packaging materials used in the production of medical products. Our ISO 15378 documentation kit can assist users in making the certification process more efficient and successful. This kit includes the ISO 15378 manual, procedures, internal audit checklist, exhibits, sample formats, etc in editable formats.
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