THE SIMPLEST WAY
FROM CONCEPT TO GOAL.
Think. Work. Integrate.
References
- Company Wasserburger Arzneimittelwerk GmbH – Recipharm
- Location Wasserburg a. Inn, Germany
- Description
- FDA Readiness of Qualification Documents
Review of qualification documents and GMP-relevant processes in preparation for an FDA audit
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- Duration 5 months
- Authorisation cGMP Compliance Review of Qualification Documents with regard to an FDA Inspection
- Description
- Examination of documents for cGMP compliance according with EU GMP guidelines and applicable FDA guidelines
Checklist creation
Review of the documents of all related trades
Testing of the elements (e.B. URS, RA, DQ, IQ, OQ, PQ, FDS, HDS, SOP ́s, logbooks, maintenance and servicing plans, alarm list, etc.) against the test criteria listed in checklist
List for possible examination questions
Weekly meetings
Implementation of workshops and lectures on relevant topics
Analysis, recommendations and notes for an FDA inspection
Final
- Company Corden Pharma GmbH
- Location Plankstadt, Germany
- Description
- Construction of a new packaging line for the packaging of veterinary medicinal products
Clean rooms, media, ventilation system
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- Duration 5 months
- Authorisation project coordination, consulting, engineering, qualification, master plan including risk analysis
- Description
- Advice on all GMP-relevant questions
Creation of the validation master plan
Engineering – URS to all individual devices
Risk analyses for all trades
Comprehensive qualification documentation
Construction supervision of all trades
Supplier coordination
Solution-oriented co-execution of the project in consultation of suppliers
- Company Ideal Pharma Packaging GmbH
- Location Brackenheim, Germany
- Description
- CRequalification of ventilation systems from the existing stock
GMP Upgrade
Requalification compressed air system
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- Duration 7 months
- Authorisation Preparation of the complete qualification documents
- Description
- Restoration of the qualification status of the existing production facilities
Requalification of a compressed air system for primary packaging
Qualification of production rooms (sampling, material locks, personnel locks)
Qualification plan
Room plans with CAD
Review of risk analysis and documentation
Document creation and execution of DQ, IQ, OQ/PQ and final reports
Videos on flow visualization
Supplier management of the service provider for requalification measurements and evaluation
- Company Corden Pharma GmbH
- Location Plankstadt, Germany
- Description
- Construction of a production plant for the production of veterinary medicinal products in existing buildings, Granulation lines, container mixer, insulator, LF workbench, container washing system, cleaning system, rooms, room monitoring, ultra-clean media, laboratory equipment
- Duration 15 months
- Authorisation project coordination, consulting, engineering, qualification
- Description
- Advice on GMP-relevant questions
Engineering – URS DQ of subprojects
Risk analyses for all trades (layout/structure of the risk analysis was carried out by Corden as
Standard established)
Comprehensive qualification documentation and implementation IQ, OQ, support of the PQ
Performance Qualification
Supplier management (coordination and review documentation)
Participation in the coordination and scheduling as well as the associated meetings
- Company Boehringer Ingelheim
- Location Deutschland
- Description
- Aseptic filling line
- Plants, process equipment
- Duration 2 years
- Authorisation Project management
- Description
- Consultation
- Project management of qualification/ validation
- Management of workshops on risk analysis
- Qualification of all plants
- Creation of the VMP and the URS
- Qualification documents
- Company Haupt Pharma, Wolfratshausen
- Location Deutschland
- Description
- Multipurpose cytostatic filling line
- Filling line, insulators
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- Duration 1 year
- Authorisation Consultation, support
- Description
- Consulting for basic design engineering
- Consulting for detailed engineering
- Consulting for isolator technology
- Screenplay for Mock-Up
- Erstellung und Durchführung des Mock-Up
- Company Nestlé Suisse SA
- Location Switzerland
- Description
- Bottling line for American market
- Food
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- Duration 3 years
- Authorisation Consulting
- Description
- All GMP questions about the American market for the food industry
- Questions about the procurement of a bottling line for the American market
- Help to prepare for FDA audit
- Project-related gap analysis
- Company Boehringer Ingelheim
- Location Deutschland
- Description
- Coater
- New plant for production building
-
- Duration 1 1/2 years
- Authorisation Project management
- Description
- Consulting and planning for introduction into the production building
- Creation of the project order
- Presentation to the Investment Committee
- Composition and management of the project team
- Conduct of all project meetings
- Risk assessments
- Cost and schedule control
- Concept planning within the project
- URS preparation
- Request for bids and award of the construction of the plant
- Supervision of commissioning
- Handover to the operation team
- Comprehensive documentation of the overall process