The GMP-compliant manufacture of medicinal products and active ingredients, cosmetics and foodstuffs is a prerequisite for successful market authorization and the marketing of products. Quality assurance plays a central role, as quality deviations have a direct impact on consumer health. In order to comply with the strict guidelines of the authorities, e.g. the European Union or the US Food and Drug Administration (FDA), the validation of manufacturing processes and the qualification of equipment, buildings and premises is a prerequisite.
With an experienced team, Chemgineering develops customized measures to achieve a status that meets the necessary regulatory requirements.
We create all relevant qualification, validation and compliance documents as well as standard operating procedures in the form of SOP templates. For audit-proof systems and processes that withstand audits at the first attempt.
Chemgineering pursues a risk-based approach. This focuses on identifying and assessing risks to product quality, data integrity and patient safety.
Our approach is as lean as possible in order to avoid duplication of effort, loss of knowledge or inefficiencies.
With experienced experts, a wealth of successfully completed projects and consistent know-how management, we ensure that you always receive the services that are required for the respective project.
Qualification
Qualification is the systematic and documented proof that a system is set up according to specifications and functions and produces according to requirements in order to ensure the required product quality, data integrity and patient safety.
Qualification is a multi-stage process consisting of the following parts:
Design qualification (DQ)
Installation qualification (IQ)
Operational qualification (OQ)
Performance qualification (PQ)
Selection of relevant services:
Projektbezogene Qualifizierung
Risikobasierte Qualifizierungskonzepte
GxP-Risikoanalysen
Erstellung von Standardarbeitsanweisungen
QS-Unterstützung
Periodische Reviews EQT + Dokumentation
Qualifizierung/Requalifizierung von EQT
Validation
Process validation is intended to demonstrate that all quality characteristics and process parameters that are considered important for ensuring validation status and acceptable product quality can be consistently met by the process. (Annex 15)
Selection of relevant services:
Computer System Validation (CSV)
Cleaning validation
Method validation
Process validation
Commissioning
Commissioning involves a series of planned activities to build, inspect, test and commission the system in accordance with the requirements of the URS in order to fulfill its intended purpose.
Commissioning includes all documents and documented tests required to operate the facilities, systems and equipment in a safe and functional environment (in accordance with the specified requirements).
Selection of relevant services:
Commissioning Master Plan (CMP)
User Requirement Specification (URS)
GxP Risk Analysis
Traceability-Matrix
Commissioning Plan
Function Checks
Installation Checks
Documents
Documented Checks
Commissioning Reporting
Process & document control
We combine qualification and commissioning to create synergies. Thanks to efficient and complete documentation as early as the commissioning stage, preparatory work for qualification can be carried out, saving time and money.
[Translate to English:] Qualifizierung (Blau) und Commissioning (Grün) gehen Hand in Hand
Your advantages with Chemgineering
Expert knowledge
Experienced employees and the opportunity to put together a team with the right "seniority" depending on the situation.
Many successfully implemented projects for well-known companies in the life sciences.
Support from all parts of the Chemgineering Group (DACH & International).
Proven experts for special topics (such as computer systems validation).
Efficiency
"As lean as possible" approach
Leveraging avoids additional costs.
Tests that have already been carried out during commissioning must be repeated during commissioning in accordance with the risk analysis.
We document in accordance with Good Documentation Practice so that tests can also be included in the qualification process.
Synergies
Through consistent know-how management and the internal training of employees "outside the box", we work together across all phases.
QVC is already considered in the concept / basic design.
This knowledge is later transferred to QVC.
Relevant Projects
Validation of COVID-19 Vaccine
Expansion of Production by Two Glass-lined Reactors
Building 305 - VAS10 - Centrifuge Plant & GMP Upgrade
New Facility HD15
New Solids Launch Facility (NSLF)
Filling line for pre-filled syringes
New sterile filling plant
Concept Design Cell Therapy Laboratory
University Hospital Basel Operation Wing East
Software validation of 3D printers
Recombinant Ebola Vaccine Production
Pharma Compliance I
Pharma Compliance II
MDR-Ready and QM-Support
IVDR-Ready and QM-Support
Requalification of a Vitamin Production Plant
Hyaluronic Acid Filler Extension: New WFI System
Production Expansion for HA Filler
Blister MedTec
GAP Analysis Cleaning Validation
Inhouse Training – Customer Specific
Development of primary packaging for parenterals
Restructuring of plasma production and sterile filling
Control unit set for autoclaves
New PW generator & automation
HVAC Qualification
New modular continuous production line for cosmetics
Validation of COVID-19 Vaccine
Transport validation of the world's first approved COVID-19 vaccine from BioNTech. Transportation at -70°C ±10°C and seamless compliance with the cold chain were essential for the rapid and safe delivery of this important vaccine.
Customer
BioNTech SE
Location
Mainz, Germany / Worldwide
Budget
Confidential
Year
Since October 2020 (ongoing)
Mandate
Consulting
Services
Transport validation of the COVID-19 vaccine (master plan, test planning and evaluation, final report)
Supply network from raw materials to finished product
Temperature mapping (-80°C to room temperature)
Expansion of Production by Two Glass-lined Reactors
Planning of two glass-lined reactors, including all connections for steam, air, cooling water, exhaust air, vacuum, nitrogen.
Customer
Biosynth AG
Location
Staad, Switzerland
Budget
1.7 Mio CHF
Year
1 Year
Mandate
Planning
Services
Process Design: Detail Design
Plant Design: 3D Laser Scanning, Layout Equipment, 3D Piping
Qualification: DQ, IQ, OQ
Commissioning: Control of Mechanical Completion
Building 305 - VAS10 - Centrifuge Plant & GMP Upgrade
Centrifuge plant. Upgrade of a cone Dryer, GMP cabin for big bag filling
Customer
DSM Nutritional Products Ltd.
Location
Sisseln, Switzerland
Budget
7 Mio. CHF
Year
2 Years
Mandate
General Planner
Services
Support of Basic Design
Detail Design
CAD 3D (PDS)
Coordination of disciplines
Construction Management
Commissioning Support
New Facility HD15
Planning and execution of a new plant (4 floors) for the production of natural products under high pressure conditions (supercritical CO2 up to 1,000 bar).
Customer
Hopfenveredelung St. Johann GmbH
Location
Wolznach, Germany
Budget
6 Mio. EUR (excl. Engineering Fees)
Year
3 Years
Mandate
General Planner
Services
Basic & detail engineering, support of the procurement process (tendering procedure, contract negotiations), construction management, support of commissioning
Chemical engineering departments: project management, HVAC incl. automation, process planning (building services, packaging unit, piping, 3-D model)
Special features: Process automation of the customer, relocation of existing process equipment (e.g. extraction system)
New Solids Launch Facility (NSLF)
New building for the production and packaging of solid dosage forms and inhalation products.
Customer
Novartis Pharma AG
Location
Stein, Switzerland
Budget
500+ Mio. CHF
Year
5 Years
Mandate
General Planner Process
Services
Project management
Concept study, basic and detailed design
3D planning pure media supply
Construction management
Qualification
Procurement support
Expediting
Document management
Filling line for pre-filled syringes
Planning of a filling line for pre-filled syringes in Switzerland, including planning of all process systems and building infrastructure through to commissioning.
Customer
International Pharmaceutical Manufacturer
Location
Switzerland
Budget
35 Mio. CHF
Year
3 Years
Mandate
General Planner
Services
Project management
Planning for all process systems and entire building infrastructure in existing production building (ventilation, clean room, connection to energy and media supply, incl. EMSR and building automation)
Conceptual design, basic design, detail design
Procurement support, expediting
Support for installation management (conversion during ongoing operations)
Planning and qualification of a complete filling line for vials using isolator technology, including automatic loading and unloading. General planning and qualification of the new system.
Customer
Merz Group Services GmbH
Location
Dessau, Germany
Budget
18 Mio. EUR
Year
2 Years
Mandate
General Planner, Qualification
Services
Qualification concept
Qualification master plan
Risk analysis
Review and approval of supplier documents
Monitoring of qualification (IQ/OQ)
Coordination of qualification (IQ/OQ)
Implementation of PQ
Concept Design Cell Therapy Laboratory
Cell therapy laboratory with various clean room zones incl. storage/logistics and technical areas. Development of the user requirements and the optimum room concept in close cooperation with six different user groups (different processes / laboratory requirements). Total area of 1,000m².
Customer
University Hospital
Location
Switzerland
Budget
Confidential
Year
2 Years
Mandate
Concept Design Planning
Services
Concept design for production area (cleanrooms incl. unclassified technical areas)
Elaboration of the qualification concept
Elaboration of user requirements and future needs
Elaboration of the optimal layout
GMP consulting
University Hospital Basel Operation Wing East
Renovation and extension (new building) of the east operating wing at Basel University Hospital. Assumption of all qualification activities, risk analyses and documents. Overall quality coordination of construction with all trades.
Customer
Basel-Stadt Building Department
Location
Basel, Switzerland
Budget
128 Mio. CHF
Year
4 Years
Mandate
Quality Assurance
Services
Monitoring and coordination of qualification activities (DQ/IQ/OQ/PQ)
Preparation of risk analyses
Preparation of DQ, IQ, OQ and PQ plans and reports
Preparation of checklists
Checking and approval of supplier documents
Overall quality coordination of construction with all trades
Software validation of 3D printers
Creation of a CSV framework, an SOP for the software development cycle and a validation strategy for the control software for 3D printers used to manufacture medical devices.
Customer
Anonymous Customer
Location
Confidential
Budget
Confidential
Year
6 Months
Mandate
Consulting
Services
Consulting: GAP analysis, risk analysis, concept development
Computerized system validation: validation plan, specification, test strategy
Operational procedures
Recombinant Ebola Vaccine Production
Conversion of a production facility, USP and DSP, for cell culture-based vaccine production, including adaptation of media, clean rooms, HVAC and chemical wastewater inactivation.
Customer
Janssen Vaccines AG (J&J, ex. Crucell)
Location
Bern, Switzerland
Budget
8. Mio EUR
Year
2 Years
Mandate
General Planner
Services
Concept design, process layout, basic design, incl. HSE and GMP reviews, detail design
Disposable equipment installation
Conversion of ventilation & media supply
Construction management and commissioning
Planning and implementation of chemical wastewater inactivation
Pharma Compliance I
Implementation and support of internal audits at the company's locations (worldwide) in a team with the customer.
Customer
International Pharmaceutical Company
Location
Switzerland
Budget
600.000 CHF
Year
1 Year
Mandate
Consulting
Services
Preparing the audits in the team
Conducting the audits on site, mostly as lead auditors
Preparing the audit reports
Checking the proposed corrective measures of the audit committee
Pharma Compliance II
Creation of a system to assess the appropriate GMP level of excipient suppliers.
Customer
Medium-sized Pharmaceutical Company
Location
Switzerland
Budget
11.000 CHF
Year
2 Months
Mandate
Consulting
Services
Preparation and implementation of a workshop on the evaluation of excipients
Creation of a concept for the evaluation of the appropriate GMP level of excipients based on the customer's existing system
Creation of the necessary SOP and documentation
Training of employees
MDR-Ready and QM-Support
Against the backdrop of regulatory changes (MDD to MDR), the requirements for various customers were determined and compliance with the new regulations was checked and documented.
Customer
Various Medtech Companies and Hospitals
Location
Münchenstein, Switzerland and others
Budget
Confidential
Year
3 Years
Mandate
Consulting
Services
Background: regulatory changes (MDD to MDR)
Actors and roles; Classification I, IIa, IIb and III, conformity assessment procedures
Safety and performance requirements, technical documentation (TD)
Against the backdrop of regulatory changes (IVDD to IVDR), the requirements for various customers were determined and compliance with the new regulations was checked and documented.
Customer
Various Medtech and Diagnostics Companies
Location
Münchenstein, Switzerland and others
Budget
Confidential
Year
4 Years
Mandate
Consulting
Services
Background: Regulatory changes (IVDD to IVDR)
Actors and roles; classification A, B, C and D, conformity assessment procedures
Safety and performance requirements, technical documentation (TD)
Requalification of an existing plant for the production of vitamins. Customer conclusion: "With this project, we were able to show the site management that it is possible to efficiently qualify an old plant with calculable costs and in compliance with the planned timelines."
Customer
DSM Nutritional Products GmbH
Location
Grenzach-Whylen, Germany
Budget
Confidential
Year
8 Months
Mandate
Qualification
Services
Development of qualification concept
Creation of URSs
Creation of risk analyses
Creation of superordinate qualification documents (QMP, QMB)
Qualification: DQ, IQ, PQ (implementation incl. test plan creation, report)
Hyaluronic Acid Filler Extension: New WFI System
Thermo (Vapor) Compression WFI-Erzeuger-, Lager- und Verteilsystem für WFI, Reindampf.
Planning, execution and commissioning of GMP production rooms and laboratories including process media.
Customer
Merz Anteis SA
Location
Lonay, Switzerland
Budget
Confidential
Year
1 Year
Mandate
General Planner
Services
Development of layout variants
Planning, tendering and construction site management:
TGA
Cleanrooms
Cleanroom and airlock furniture
Electrical and sanitary installations
Process media and distribution (gases, vacuum and WFI)
Construction activities
WFI production and storage
2 GMP washing machines
Qualification support
Blister MedTec
Facility for the production of blisters for medical products.
Customer
Ivers - Lee AG
Location
Burgdorf, Switzerland
Budget
Confidential
Year
1 Year
Mandate
Project Management and Planning
Services
Project management
Concept development incl. cost estimation
Plant engineering
Infrastructure planning
Qualification
GAP Analysis Cleaning Validation
Evaluation of the hygienic design, GAP analysis and strategy development for cleaning validation.
Customer
International Medical Technology Company
Location
Rotkreuz, Switzerland
Budget
800.000 CHF
Year
1 Year
Mandate
Concept Study
Services
Project management
Hygienic process design
GAP analysis
Qualification/validation
Cost estimate
Inhouse Training – Customer Specific
Planning and execution of customer-specific in-house training courses, topics as required, e.g: CSV, GMP basics, data integrity.
Customer
Several Customers, Classroom Seminar or Online Training
Budget
variable
Year
ongoing
Mandate
Consulting
Services
Depending on subject areas and duration from approx. CHF 2,300
Duration from half a day. Typically 1-2 days
Determining the training requirements
Drawing up a training schedule, coordinating the content and duration
Preparing the content and training documents
Conducting the training, possibly in combination with a topic-specific workshop
Issuing training certificates
Development of primary packaging for parenterals
Development of a new primary packaging material for parenteral application.
Customer
Hoffmann Neopac AG
Location
Oberdiessbach, Switzerland
Budget
confidential
Year
2 Years
Mandate
Project Management and Planning
Services
Project management (internal + external)
Concept study
Plant engineering
Infrastructure planning
Qualification
SAP validation
Support adaptation of QA system
Restructuring of plasma production and sterile filling
GMP-compliant conversion of plasma processing (10,000 m2) incl. PM for new sterile filling.
Customer
Biotest Pharma GmbH
Location
Dreieich, Germany
Budget
50 Mio. €
Year
6 Years
Mandate
General Planner
Services
GMP concept development
Concept planning
Process description
Basic engineering
Project management
Detailed scheduling
ERP system implementation in production
Cleaning validation / media fills
Control unit set for autoclaves
Replacement control (Hardware and Software) of two autoclaves, Siemens S5 to Siemens S7: Qualification of the new control (access protection, audit trail, monitoring, process) of a small autoclave as a pilot project. Analog implementation of a large autoclave.
Customer
Novartis Pharma Stein AG
Location
Stein, Switzerland
Budget
500.000 CHF
Year
1 Year
Mandate
Confidential
Services
Project management
Preparation of qualification documentation
Implementation of qualification
Coordination of qualification activities
Preparation of final documentation
New PW generator & automation
Procurement of new PW generators, adaptation of automation incl. connection to BMS + MAS, dismantling of existing generators.
Customer
Novartis Pharma AG
Location
Wehr, Germany
Budget
500.000 EUR
Year
1 Year
Mandate
General Planner
Services
Concept planning
Basic and detail engineering
Preparation of URS and tender documents
Installation and commissioning support
GxP, functional and HSE risk analyses
Qualification plans
Coordination and implementation of qualification activities (DQ, IQ, OQ)
HVAC Qualification
Design review and qualification of the HVAC systems in the new building for oral solid and liquid dosage forms (production and packaging).
Customer
Ilko Ilac
Location
Konya, Turkey
Budget
5 Mio. EUR
Year
1 Year
Mandate
Design Review and Qualification
Services
Technical and GMP design review of HVAC systems
Qualification of HVAC systems
Preparation of all qualification documents for QMP, RA, DQ, IQ, OQ and PQ
Coordination and monitoring of qualification activities
New modular continuous production line for cosmetics
Design of a modular and standardized production line for cosmetic products. The production line was integrated into an existing building at the site.
Customer
Multinational Cosmetics Company
Location
Mexico
Budget
15,6 Mio. EUR
Year
1 Year
Mandate
Engineering Design
Services
Detail Design of the production line
HAZOP & ATEX assessment
Design Qualification
URS for procurement
If you have any questions about qualification, validation or commissioning, please contact us
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