ES1-05Semiconductor & Optoelectronics Solution

LUNA Engineering

Name: LUNA Industrial Automation
Address: 1599 Fengpu Avenue, Fengxian District, Shanghai, Shanghai, 201400, CN
Telephone: +86 189 1715 6222
Price range: $$$

Process-Validation-v1

LUNA process validation service for pharma/food/medical device, protocol writing/execution/report/regulatory support, FDA 2011/EU Annex 15/ICH Q10, FMEA.

$22,000in stock

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Specifications

Scope: Process validation for pharma, food, medical device
Steps: Protocol writing, execution, report, regulatory submission support
Standards: FDA Process Validation Guidance 2011, EU Annex 15, ICH Q10
Duration: 2-16 weeks
Risk tool: FMEA + critical process parameter mapping