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- Calibration
  
  We are one of the leading calibration laboratories in Europe and accredited for more than 300 calibration procedures according to ISO/IEC 17025:2017.
  Calibration
- Our measured variables
  Our accredited laboratories cover almost all measurands and offer a unique service portfolio.
- On-site Calibration
  We calibrate test equipment and measuring points at our customers' sites with professional competence and high-precision equipment.
- Calibration equipment
  With our portable calibrators for temperature, humidity and pressure, calibrations can be carried out regardless of location.
- Test equipment management
  
  We manage your test equipment with the holistic test equipment management solution PRIMAS for compliance with standards and directives.
  Test equipment management
- PRIMAS online
  The internet-based test equipment management system PRIMAS online supports the assurance of test equipment requirements - even while on the road.
- PRIMAS validated
  PRIMAS validated is a validation-enabled test equipment management system for companies with GxP compliance requirements.
- PRIMAS exchange
  PRIMAS exchange enables automated data transfer of test equipment data between MES/CAQ systems and our data master.
- PRIMAS connect
  PRIMAS connect is a web service for automated access and queries to PRIMAS online in the Testo Industrial Services data system.
- Qualification
  
  We support qualification projects such as cleanroom qualification or plant qualification. We also qualify warehouses and transport systems according to GDP and GSP standards.
  Qualification
- Qualification of cleanrooms
  Professional support for all GMP measures in the area of cleanroom qualification - from conception to implementation.
- Qualification of plants and utilities
  Risk-based qualification of process plants, supply systems and utilities for sustainable safety of process stability and robustness.
- Transport and storage qualification
  Storage and transport qualification to ensure uniform temperature and climate conditions and maintain product quality.
- Validation
  
  We take care of cleaning, process and transport validation as well as computer and software validation to ensure reproducibility and robustness.
  Validation
- Cleaning validation
  Holistic handling of professional cleaning validations as well as support for validation projects and revalidation measures.
- Process validation
  Risk-based process validation to demonstrate the fulfilment of process requirements and outcomes, and to ensure product quality.
- Transport validation
  Transport validation to ensure stable climate conditions during logistics and transport of sensitive goods to the consumer.
- Computer and software validation
  Computer and software validation (CSV) to ensure the reproducibility of procedures and processes of computer-based systems.

What is the difference between qualification and validation?

The knowledge area qualification answers basic questions on the distinction between qualification and validation, the qualification phases and the requirements for the storage and transport of medicinal products.

Here you will find answers to the following questions:

What is the difference between a qualification and a validation?
What are the qualification phases?
Do the high-quality requirements also apply to the storage and transport of medicinal products?
What are the objectives of quality risk management according to ICH Q9?

What is the difference between a qualification and a validation?

Qualification involves providing documented evidence that facilities, production and supply equipment, and premises are suitable for the intended purpose. Validation, on the other hand, provides evidence of the suitability of processes and procedures.

 What are the qualification phases?

In the life cycle of a plant, different phases of qualification are distinguished:

DQ: Design qualification
IQ: Installation qualification
OQ: Operational Qualification
PQ: Performance Qualification

Sequence of a plant qualification

Do the high-quality requirements also apply to the storage and transport of medicinal products?

Yes, the high-quality requirements are firmly anchored in the Good Storage Practice (GSP) and the Good Distribution Practice (GDP). In its individual phases, the storage and transport process is influenced by quality risks of varying degrees, which must be adequately controlled. Qualification and validation measures can minimise these critical influencing factors and demonstrate compliance with GxP requirements.

Transport and storage qualification

What are the objectives of quality risk management according to ICH Q9?

The objectives are to identify, assess and reduce risks that could in any way negatively affect the quality of products and thus the safety of medicines. In this context, risk is defined as the combination of the probability of occurrence of a loss and its magnitude.