 "Plant qualification for medical devices | ENGEL")
- Home
- 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 |
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.
 "Legal basis for medical devices GMP documentation | ENGEL")
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)
-
![Picture shows injection molding machine e-motion from ENGEL]( "High-precision injection molding in medical technology | ENGEL")
Blog![Markus Malleck]( "Markus Malleck")
Markus MalleckMarch 1, 2023Medical technology injection molding at the highest levelMarch 1, 2023Electric injection molding machine e-motion meets demanding requirements at Fresenius Medical Care
-
medical technologies
-
systems solution
-
consultancy
11 minutes -
 "High-precision injection molding in medical technology | ENGEL")
)
