Our experienced team – a risk-based approach – efficient qualification and validation for your project

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

What does qualification mean?

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)

What services do we offer?

• Project-related qualification
• Risk-based qualification concepts
• GxP risk analysis
• GAP analysis and mock audits
• Creation of standard operating procedures (SOPs)
• QS-support
• Periodic reviews EQT + Documentation
• Qualification/requalification of EQT
• Laboratory qualification
• clean room qualification
• qualification of API synthesis plants
• qualification of chemical plants
• qualification of biotechnology facilities
• qualification of sterile and non-sterile pharmaceutical production facilities
• qualification of automation systems
• qualification of cleaning processes and systems (washing machines, CIP, stopper washing)
• qualification of sterilization processes and systems (autoclaves, SIP, stopper sterilization)
• qualification of containment-equipment (isolators, RABS, laminar flows, VHP decontamination equipment and processes) 

Validation

What does validation mean?

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)

What services do we offer?

• Computer System Validation (CSV)
• Cleaning validation
• Method validation
• Process validation

Commissioning

What does commissioning mean?

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).

What services do we offer?

• Commissioning Master Plan (CMP)
• User Requirement Specification (URS)
• GxP Risk Analysis
• Traceability-Matrix
• Commissioning Plan
• Function Checks
• Installation Checks
• Documents
• Documented Checks
• Commissioning Reporting

Frequently asked questions about commissioning, qualification, and validation

How important is efficient documentation in commissioning, qualification, and validation?

Documentation is very important, because an efficient approach to documentation has an impact on all subsequent phases. Efficient document management, which starts as early as commissioning, avoids extra work in qualification and thus creates efficiencies. So-called "leveraging" prevents additional work. Tests that have already been carried out during commissioning can also be transferred to qualification through documentation in accordance with GDP (Good Documentation Practice).

What are the advantages of having an experienced team for commissioning, qualification, and validation projects?

Contributing expert knowledge and experienced employees to projects is invaluable. Our large team of experienced engineers from a wide variety of backgrounds allows us to put together the right team with the necessary seniority and experience in specific areas, depending on the situation. At any given time, we have exactly the right people on board to ensure the success of the project.

Many successfully implemented projects in commissioning, qualification, and validation speak for us here. Thanks to the interaction within the Chemgineering Group, we can draw on support from all parts of the company (DACH and international) and thus also have access to experts for niche topics.

How can synergies in commissioning, qualification, and validation be leveraged in a targeted manner?

Through consistent know-how management and internal training of employees to "think outside the box," we work together across all phases. Commissioning, qualification, and validation should already be considered during the engineering phases—and thus from the very beginning. The knowledge gathered is then seamlessly transferred to CQV later on, thus avoiding additional work.

How can processes and document control be implemented efficiently?

Qualification and commissioning should be considered together in order to create synergies. Efficient and complete documentation during commissioning in accordance with Good Documentation Practice (GDP) allows preparatory work for qualification to be carried out, saving time and money.