GMP Qualification

Support for all necessary qualification tasks

SCHRADER GMP Qualification

As a supplier of pharmaceutical and food technology systems, SCHRADER offers support in all necessary qualification tasks.

The qualification process is carried out in accordance with the standards set out in the EU GMP Directive 2003/94/EC Annex 15 Point 3, the resulting documents are submitted to the customer for review and approval before the respective process step. The process is carried out according to the V-model described in the SCHRADER internal qualification plan.

First, the customer’s requirements are formulated in the User Requirement Specification (URS). After receiving this User Requirement Specification, SCHRADER creates a functional specification sheet from it, in which the requirements are checked for feasibility and implementation and commented on. This functional specification sheet serves as the basis for all subsequent steps.

After awarding the contract, the technical specifications are defined in detail and the risk assessment is carried out in accordance with the qualification plan. The risk assessment is carried out in the form of a Failure Mode and Effects Analysis (FMEA). In the Failure Mode and Effects analysis (FMEA), all plant-related risks with regard to product quality are identified and evaluated, in order to derive appropriate measures to ensure consistently high product quality.

As a matter of principle, SCHRADER carries out the following qualification and validation activities for your plant in line with Annex 15 of the EU GMP guidelines:

Design Qualification –
(DQ)

Factory Acceptance Test (FAT)

Installation Qualification -
(IQ)

Operational Qualification –
(OQ)

Site Acceptance Test -
(SAT)

Performance Qualification –
(PQ)

The Design Qualification (DQ) is written proof that the proposed plant design meets the requirements of the specifications. Important criteria are checked before production, e.g. compliance with the 3D rule for outlets and valves or control-relevant documents. With the completion of the DQ, the production approval is granted.

The Factory Acceptance Test (FAT) is used to check the system before delivery and installation and includes, among other things, the spray masking test with riboflavin solution according to the VDMA leaflet or the software acceptance. The FAT is often part of the software validation concept. After a successful FAT, the system is shipped and assembled and the software can be installed.

The installation qualification (IQ) includes the verification of the equipment for the requirements defined in the specifications, the correct installation, as well as the verification of the construction materials used. IQ also includes the input/output test (input/output, I/O).

The Operational Qualification (OQ) is the written proof that the equipment and the respective plant unit comply with the technical specifications in terms of their function. It is used to check the correct system function over the entire defined operating range.

The Site Acceptance Test (SAT) includes a supplementary inspection of the FAT after transport and installation at the customer’s premises and includes a performance run of the system.

The Performance Qualification (PQ) checks the function of the system, including the upper and lower operating areas. Although the PQ is a system-oriented qualification step, it is tailored to the individual process of the customer. Typical criteria for the PQ are the passing of the cleaning validation and sufficient batch homogeneity of the product batches. Due to the resulting operational regulations and high-level requirements, the PQ can only be carried out on site by the customer, and optionally with the support of SCHRADER.

Especially in the pharmaceutical industry, quality assurance is of particular importance, since quality deviations can have a direct impact on health.

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