Product/Service

Pharmaceutical Qualification Services

Source: M+W Group

The production process for products in the pharmaceutical industries  is subject to increasingly more stringent regulations by the authorities and must comply with FDA and European standards.

The production process for products in the pharmaceutical industries  is subject to increasingly more stringent regulations by the authorities and must comply with FDA and European standards. If you operate a plant subject to validation you must provide evidence that your entire pharmaceutical process control system complies with the specification and its operation is reproducible.

We are well-prepared for these pharmaceutical requirements and will gladly assist you during every stage of the qualification process:

  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

The entire planning process is described in the design specifications. At this stage we ensure that you requirements are fully being met and that all overriding directives and laws are being complied with. Specific work instructions (SOPs) ensure not only GMP-compliant execution, but also the maintenance of the qualified status.