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Services

Qualification and Validation

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:

 

Selection of relevant services:

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:

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:

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.

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

If you have any questions about qualification, validation or commissioning, please contact us

We help you to successfully implement your project.

With professional qualification, validation and commissioning. Get in touch with us.

Switzerland +41 (0) 61 467 54 00
Germany +49 (0) 611 778870
Spain +34 (0) 932 38 49 90