ISO 15378 Certification is a quality assurance for primary packaging materials for medical products specific prerequisites for the utilization of ISO 9001:2008, with reference to GMP. In 2006, the procedure-oriented ISO 15378 standard was delivered. In view of the globally acknowledged ISO 9001 quality standard, it contains all the GMP essentials appropriate to primary packaging material, for example, batch tracing, risk management, validation, and controlled environment.
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 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
Operon Strategist support the manufacturers of primary packaging materials for the medicinal product to enhance their QMS system by addressing specific requirements to meet the quality objectives as per ISO 15378 certification. Operon Strategist assist the pharmaceutical and medical device industries to assess their suppliers of primary packaging materials and increase overall product quality.
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Phone no - 9325283428
Mail - dm@operonstrategist.comIf You Want Medical Devices Services Consultation For Following.- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
If You Want Medical Devices Services Consultation For Following.
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
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