ISO 15378:2017 Primary packaging materials for medicinal products
This 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.
Structure
- Scope
- Normative references
- Terms and definitions
- Context of the organization
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- 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
ISO 15378:2017 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 encourage 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.