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Image shows plant qualification from ENGEL
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  • GMP Documentation

ENGEL GMP Documentation

Your Basis for a Functioning Quality Management

Whether medical devices or diagnostics: ENGEL GMP documentation provides you with a comprehensive, well-founded system qualification. It supports you in meeting the basic legal requirements for placing your products on the market, both nationally and internationally.

Already in the planning phase of each project, your created specification sheet is exactly implemented in the ENGEL Functional Specification. Together with the impact assessment, the risk analysis and the ERES/GAMP classification, this is the basis for the design. These requirements, documented in detail, are precisely implemented during the construction of your plant. Subsequently checked step by step and documented again.

The Essential Points of the ENGEL GMP Documentation

Topic Description
Scope & Objective
Responsibilities & Organization
Definitions & System Structure
Impact Assessment IA Basis for the assessment of the assembly & components with regard to qualification relevance; the scope of qualification is determined.
GxP/ERES/GAMP Classification Basis for classification of computer aided systems regarding GxP relevance, classification according to GAMP5 and determination of ERES relevance according to 211 CFR Part 11 - GAMP 5 Class 3
Risk Analysis RA Examination of the groups & components whether they meet GMP requirements, determination of the depth of testing for DQ, IQ & OQ
Master Qualification Plan MQP Conceptual description of qualification activities for injection molding machines
Design Qualification DQ Evidence that all specifications & standards defined in the MQP are met and that the risk for the products to be manufactured and/or the environment is reduced to an acceptable level
Installation Qualification IQ Documented evidence that all relevant assemblies or components have been assembled & installed in a DQ-compliant manner.
Operation Qualification OQ Proof that the injection molding machine in the "as built/at rest" condition achieves the specifications defined in the specification sheet; measurement takes place after commissioning
Factory Acceptance Test FAT Acceptance protocol at the manufacturer's plant including documentation of changes prior to delivery
Acceptance at installation site SAT Acceptance protocol at the operator site
Requalification at the operator's plant Periodic review of the acceptance criteria
Picture shows customer Helvoet with ENGEL employees
GMP Documentation in Practice
ENGEL Supplies Complete System Including GMP Documentation

An injection molding system solution saves costs and speeds up commissioning. ENGEL also includes the GMP documentation into the overall package. The advantage for customer Helvoet: even more efficient project handling and a consistently optimized production cell.

Picture shows a person in the injection molding clean room of ENGEL
Legal Basis for Medical Devices

EU Directives:

  • Medical Device Regulation, MDR

  • In Vitro Diagnostics Regulation, IVDR

National laws (example):

  • Medical Devices Act in Germany

Recognized standard:

  • ISO 13485

USA guidelines:

  • Code of Federal Regulation Title 21 Part 820 (21 CFR 820)

  • Current Good Manufacturing Practice (c'GMP)

Other recognized guideline:

  • Good Automated Manufacturing Practice (GAMP 5)

Markus Lettau

Molding Industry Business Advisor

+1 (717) 767 2016

Write us

The ENGEL team is happy to support you with extensive knowledge in the field of injection molding.