Comment 0Times Lookup 419psc Date Created 23-08-18 15:01
Pharmaceutical Packaging Material Quality Management System Specification Standard
ISO 15378 adheres to GMP (Good Manufacturing Practice) principles and is a standard for primary packaging materials for pharmaceuticals. It is an international standard related to good pharmaceutical manufacturing and quality control (GMP) by applying ISO 9001 quality management system requirements.
This standard provides guidelines for pharmaceutical manufacturers to ensure quality and safety in the process of producing and providing primary packaging materials, and to establish an appropriate quality management system in compliance with GMP principles. GMP contains internationally recognized principles to ensure the highest quality and safety in the pharmaceutical industry.
This standard specifies the requirements for pharmaceutical manufacturers to ensure high quality and safety in the production and control of packaging materials. The ISO 15378 standard covers glass, plastic, rubber, aluminum, and others used in pharmaceutical packaging.
Pharmaceutical manufacturers need to comply with the requirements to ensure high quality and safety in the production and management of packaging materials.
ISO 15378 covers the following key aspects.
- • Quality Management System: Provides guidelines for manufacturers to establish appropriate systems for controlling, monitoring and quality control of the production process of packaging materials.
- • Raw material selection and purchase: The quality of packaging materials is highly dependent on the quality of raw materials. ISO 15378 defines requirements and procedures for the selection and purchase of raw materials.
- • Quality Management and Inspection: ISO 15378 sets standards for methods and procedures for manufacturers to continuously assess the quality of packaging materials, conduct risk assessments and conduct inspections by including risk management in their processes.
- • Quality Assurance: ISO 15378 ensures the safety and effectiveness of pharmaceuticals by minimizing risks and rejects during manufacturing.
- • Compliance with GMP principles: GMP principles will increase the efficiency of a manufacturer's production process.
ISO 15378 provides useful guidelines and standards for manufacturers who must follow regulations to maintain and improve the quality and safety of pharmaceutical packaging materials. By complying with these standards, pharmaceutical manufacturers can supply high-quality packaging materials and ensure safety.
Key features of ISO 15378
- • Ensuring quality and safety: ISO 15378 takes seriously the quality and safety of pharmaceutical packaging materials and ensures product safety through proper quality control.
- • Compliance with Regulatory Requirements: This standard helps meet international regulations and requirements that apply to the pharmaceutical industry. This allows businesses to increase their stability in legal terms.
- • Increase customer confidence: Companies that have been certified to ISO 15378 establish a high level of confidence in product quality and safety. This can increase customer satisfaction and gain more market share.
- • Issue prevention and action: ISO 15378 helps to maintain product quality and safety continuously by preventing potential issues in advance and taking quick and effective action on problems that arise.
- • Continuous improvement: ISO 15378 encourages companies to pursue continuous improvement. A higher level of quality is achieved through the process of improving the quality management system.
Benefits of ISO 15378 certification include
- • Providing safe products to patients and consumers
- • Reinforcing competitiveness in the international market
- • Reduce legal risk
- • Cost reduction and productivity improvement
By complying with the ISO 15378 standard, pharmaceutical manufacturers can supply high-quality packaging materials, ensure safety, and remain competitive in the global market.
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