Operon strategist provide consultancy for ISO 15378 Certification

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.

What is ISO 15378 Certification ?

• ISO 15378:2017 standard indicates requirements for a quality management system where an organization needs to show its capacity to give primary packaging materials for medicinal products, which reliably meet customer requirements, including regulatory requirements and International Standards relevant to primary packaging medicinal materials
• An ISO 15378:2017 certificate with its wholistic way to deal with GMP and quality necessities is perceived all through the world. It delivers manufacturers of primary packaging materials with an appropriate capability for customer approval – just as improving the organization’s image according to the authorities. ISO 15378:2017 applies to all manufacturers of packaging materials that come into direct contact with the medical products. The standard covers all the typical materials, such as glass, rubber, aluminium, and plastics.
• This ISO standard is currently lined up with ISO 9001:2015 and has same 10 elements high-level structure. ISO 15378:2017 determines necessities for a quality management system where an association needs to exhibit its capacity to deliver primary packaging materials for medicinal products, which reliably meet customer requirements, including regulatory prerequisites and International Standards pertinent to primary packaging materials.
• Objective to upgrade customer satisfaction through the effective use of the system, including processes for the development of the system and the confirmation of conformity to client and material statutory and regulatory necessities.
• The primary packaging material is identified as the material that is in direct contact with the measurement structure. With the involvement in Primary packaging standard which may require any single part of a container closure system which includes containers, container liners, closures, closure liners, stopper oversells, etc.

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.

Read More - ISO 15378 Certification

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device