In addition to ISO 9001, this document specifies 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.In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.
ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.
Know more About the - ISO 15378 certification for medical device
What are the benefits of ISO 15378 Benefits?
- ISO 15378 Standard has strategic tools that reduce costs by minimizing waste and manufacturing errors and increasing productivity.
- It encourages organizations to get to new markets and encourages free and reasonable worldwide exchange.
- The manufacturer can improve their proficiency of production processes by following GMP standards according to ISO 15378 standard.
- To relieve your risks particularly identified with product contamination, mix-ups and errors and ensure product efficacy and shelf life.
- Assurance of quality products to your clients. Upgrade customer satisfaction.
- Competitive Advantage over other non- confirmed providers.
- Application of risk management helps to reduce errors associated with the product.
ISO 15378 certification - Primary Packaging Material for Medicinal standard
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.
SGS provides reliable, independent ISO 15378 certification for your pharmaceutical packaging materials manufacturing operation. During your audit prior to certification we analyse your operation, identifying strengths and outlining the areas where improvement is necessary.
SGS is a globally recognised leader in certification for the pharmaceutical sector. The SGS global network of auditors understand your manufacturing processes and the precise meaning of all aspects of the standard. The ISO 15378:2006 standard includes a number of 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
Partner with SGS when you need to demonstrate your ability to quality provide packaging materials for the pharmaceutical industry and help improve patient safety. Contact us today to learn more about ISO15378 – Primary Packaging for Medicinal Products certification.