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Picture shows plant qualification by ENGEL
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  • GMP Documentation

ENGEL GMP Documentation

Your Basis for Quality Management

Whether medical devices or diagnostics: ENGEL GMP documentation provides you with comprehensive, in-depth machine qualification. Our experts will help you to meet the legal preconditions for marketing your products both nationally and internationally.

As early as in the planning phase of each project, we implement your specification sheet precisely in the ENGEL Functional Specification, documenting all specifications in every detail. Together with Impact Assessment, Risk Analysis and ERES/GAMP Classification, this forms the basis for the design of your machine. All your requirements are precisely implemented, then checked step by step and once again documented.

The Essential Points of ENGEL GMP Documentation

Topic Description
Scope & Objectives
Responsibilities & Organisation
Definitions & System Layout
Impact Assessment IA Basis for the assessment of the assembly & components with regard to qualification relevance; the qualification scope is defined
GxP/ERES/GAMP Classification Basis for classification of computer aided systems in terms of GxP relevance, classification according to GAMP 5 and determining the relevance according to ERES 211 CFR Part 11 - GAMP 5 classification 3
Risk Analysis RA Investigation of the assemblies & components to establish whether they meet GMP requirements; determination of the testing depth for DQ, IQ & OQ
Master Qualification Plan MQP Conceptual description of the qualification activities for injection moulding machines
Design Qualification DQ Proof that all the requirements specified in the MQP specifications & standards are met and the risk for the products to be manufactured and/or the environment has been reduced to an acceptable level
Installation Qualification IQ Documented evidence that all relevant assemblies or components have been fitted and installed in a DQ-compliant manner
Operation Qualification OQ Proof that the injection moulding machine in the "as built/at rest" state meets specifications defined in the Performance Specifications; measurements are performed after commissioning
Factory Acceptance Test FAT Acceptance certificate at the manufacturing plant, including documentation of the changes prior to delivery
Site Acceptance Test SAT Acceptance certificate at the operator's location
Re-qualification at the operator's plant Re-inspection of the acceptance criteria
Picture shows customer Helvoet with ENGEL employees
GMP documentation in Practice
ENGEL Supplies Complete System Including GMP Documentation

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

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

EU guidelines:

  • Medical Device Regulation, MDR

  • In Vitro Diagnostics Regulation, IVDR

National legislation (example):

  • Medical Devices Act in Germany

Recognised standard:

  • ISO 13485

USA directives:

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

  • Current Good Manufacturing Practise (c’GMP)

Other recognised guidelines:

  • Good Automated Manufacturing Practise (GAMP 5)

ENGEL Team

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The ENGEL team will be happy to assist you with comprehensive know-how on the subject of injection moulding.