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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 |
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.
 "Legal basis for medical devices GMP documentation | ENGEL")
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)
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