Qualification & Validation

We provide quality

The validation guaranteed the quality of your products.

It is the documented proof that the production plant and the product correspond to the required high quality standards at any time. Here, it is necessary to keep the directions of the EU and of the FDA (GMP standards), to find out entrapments, to access riscs in the right ways and to profit from optimization possibilities.

Please, contact us. Together, we are finding the optimum solution for you.

By means of our outstanding knowledge and experiences, we are supporting you in the smooth handling of the validation works on our process plants.

On the basis of a validation master plan, proceedings and responsibilities are determined – from the Design Qualification (DQ) via the comparison of the installed plants and equipment with flow charts and specifications (Installations Qualification - IQ) as well as functional tests (Operations Qualification - OQ) up to the final Performance Qualification (PQ).
We are supporting these works by arranging all necessary GMP conform documents or, if requested, carry out these works by ourselves in a budget-compliant way.

Performance

When carrying out the qualification / validation, we test with the final customer the design, the installation, the functionality as well as the performance of the plant and the corresponding processes based on a detailled risk analysis in the below mentioned phases by means of documents and tests according to the criteria prescribed in the specifications.

Over the past years, the NETZSCH Vakumix has achieved special competence and experiences with the validation of automated plants, e.g. acc. To standard 21 CFR Part 11 "Electronic Records, Electronic Signature" and acc. to GAMP 4.

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Within the scope of the Design Qualification (DQ),

  • all product-relevant calculations and constructional designs carried out within the scope of the Detail Engineering are submitted for approval and
  • a complete documentation of all approved components is provided.

Within the scope of the Installations Qualification (IQ),

  • all components, measuring systems and fittings of the plant are tested regarding the type used, a correct installation and the function in reference of the documents resulting from the requirements specification,
  • the completeness and correctness of the documentation is checked,
  • the completeness of the documentation and the retraceability of the welding works and the used materials are verified,
  • the functioning of the measuring systems regarding the measuring ranges and the preciseness is tested and
  • a precise documentation / description of the tests carried out is made.

Within the scope of the Operational Qualification (OQ),

  • all automated operations regarding the operation, start and stop conditions, behaviour with malfunctioning / maloperation are tested,
  • the mode of operation of the CIP – function is tested by a “spray ball efficiency test“,
  • the operation of the safety devices are tested,
  • the operation of the plant with breakdown of single media is tested and
  • a precise documentation / description of the tests carried out is made.

Within the scope of the Performance Qualification (PQ), according to the customer’s requirements (PQ)

  • functions critical in terms of time, e.g. heating and cooling of product or heating time of the plant with SIP functions, are tested and
  • a precise documentation / description is made.

For further detailled information please contact us.

Definition

The term "Qualification" means that plants work perfectly and the expected results are realized in fact. (EU-GMP – guideline)

The “Validation“ mainly refers to methods, processes and computer systems. It is “the proof in accordance with the basics of a good production practise that methods, processes, equipment, material, working steps and systems leads really to the expected results“ (EU-GMP-guideline).