Validation for Injection Molding

At Chippewa Plastics, we understand the importance of Validation for your Plastic Parts, especially when it comes to FDA Validation for Regulated industries. 

21 CFR 820.3 (z)(1) defines Process Validation as "establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications"

Our team knows how to structure your Master Validation Plan (MVP) with a risk-based approach that won't leave you buried in documentation. We have attended FDA training and defended our protocols and reports in FDA Inspections. Ask about our depth of knowledge in: 

• IQ
• OQ/OQ-E
• PQ

Validation addresses our Customer's needs:

• Ensure parts meet all specifications for intended use
• Proactive approach to reduce field failures
• Meet regulatory requirements as FDA defined special process
• Support First Article Inspection (FAI), APQP, and PPAP