Pharma-grade materials at Rhein-Plast

Only qualified raw materials with a DMF number for complete regulatory transparency and traceability.

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explanation

What does Pharmagrade mean?

Definition and relevance for the regulated pharmaceutical environment

The term "Pharmagrade" refers to raw materials specifically for the regulated pharmaceutical environment. Each batch has a DMF number and is fully traceable.

Our approach

Our pharmaceutical-grade approach

GMP manufacturing, risk-based processes, qualified equipment

GMP manufacturing in accordance with EudraLex

Volume 4, risk-based processes

Qualified attachments

Validated procedures, cleanroom conditions

Full traceability

DMF number per batch, documented supply chain

Verified conformity

Test protocols according to Ph. Eur. and USP

advantages

Your advantage: regulatory certainty

Simplified approval procedures and maximum compliance

Simplified FDA/EMA approval procedures

Declarations of conformity and certificates available on request

Stability and purity of sensitive products ensured

Complete traceability of every raw material batch

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Discuss pharmaceutical-grade requirements

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