Manufacturing
Plant Layout Design – Facility Layout Design
Manufacturing plant layout design is the primary step for manufacturing plant setup. Medical Device Manufacturing plant must be compliant with the rules given by respective regulatory bodies like USFDA, CDSCO etc.When it comes to the right design of the facility, the man and material flow are to be taken into consideration. The product segregation, product manufacturing flows and process steps, the use of the classified areas play an important role. The good experience handholding will lead to the correct decision makings of the same this will ensure a smooth transition during audits from regulatory bodies & customers. The manufacturing plant layout design is prepared by our Auto-CAD expert based on inputs from the client & their architect/civil engineer.
Manufacturing Plant Layout Design
The best demonstration of the compliance can be achieved by the right design. The right design minimises the manual errors and requires the least effort in controlling the activities. Hence the right design of product, manufacturing site and the system plays the vital role in the quality of products and take care of the future issues that may crop up because of poor designs.
There are various expectations “implied“ and “expected to be understood” laid down by the regulators across the world. Some of the expectations can be well understood and compiled in the facility based on the experience of the regulatory audits. In the case of the existing facility, it is very important to know the facility compliance before applying for the regulatory audits to avoid the irreversible losses at the end of the facility audit. Our manufacturing plant layout design is appreciated by various regulatory for their compliances and the for minimal man and material movements and products segregations.
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Contact details –
Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.
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
- 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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