Qualification and validation

The GMP-compliant manufacture of pharmaceuticals and active ingredients, cosmetics and food is a prerequisite for a successful marketing authorization and the marketing of the products. Quality assurance plays a key role since quality deviations can have a direct impact on the health of consumers. In order to comply with the strict guidelines of the authorities, e.g. the European Union or the US Food and Drug Administration (FDA), validation of the manufacturing processes and the qualification of equipment, buildings and premises are absolutely necessary.

With an experienced team, Chemgineering develops individualized measures to achieve a status that meets the required regulatory requirements. We prepare all the relevant qualification, validation and compliance documents as well as standard work instructions in the form of SOP templates. For audit-proof systems and processes that withstand audits from the very onset.

V modell

Chemgineering uses the V-model for systematic qualification. The GMP critical points of user requirements, system specifications and technical specifications are reflected in the individual tests.

Qualification plan: System-specific qualification activities, responsibilities, scheduling and documents to be created are defined.System specifications (FS, HDS, SDS, R & I / EMSR scheme): Description of the technical equipment as a basis for development, construction and installation.

SAT test: Technical acceptance in the supplier's factory / technical acceptance after delivery and installation by the operator / user.

Design qualification (DQ): Documented proof that quality-relevant requirements were taken into account during planning. The compliance with URS and system specifications is checked.

Installation qualification (IQ): Documented proof that equipment and systems have been delivered and installed in accordance with GMP-critical requirements and statutory safety regulations. Measuring and control technology, built-in materials, surfaces and quality-relevant measuring points are tested.

Operational qualification (OQ): Documented proof that the system functionality defined in accordance with the system specifications is completely fulfilled within the entire working area and within specified limits. Qualification report: Approval of the OQ report can be started with a subsequent PQ or process validation.

Performance qualification (PQ): Documented proof that all the relevant plant components and systems meet the defined specifications and requirements in an operating condition.

Our services in the field of qualification and validation:

  • Individual qualification concepts
  • Risk analyses
  • Standard work instructions
  • Plant qualification
  • Qualification reviews
  • Re-qualification
  • Qualification in the context of decommissioning
  • Qualification of laboratory equipment
  • Process validation
  • Cleaning validation
  • Sterilization validation
  • Transport validation

Other topics

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