GMP-compliant documentation

GMP-compliant documentation at E+K Sortiersysteme

The abbreviation GMP stands for ‘Good Manufacturing Practice’. This quality assurance system is of crucial importance for the production of medicinal products. GMP defines the strict requirements and standards that must be met in the pharmaceutical industry. Qualification is an essential part of GMP quality assurance, as it serves as the basis for the validation of technical systems. Qualification represents the first step in the validation procedure.

E+K Sortiersysteme offers GMP-compliant documentation and system qualification packages to ensure GMP-compliant system development, especially for the pharmaceutical industry. Our scope of services covers the crucial phases DQ (Design Qualification), IQ (Installation Qualification) all the way to OQ (Operational Qualification).

Software development at E+K is carried out in accordance with the GAMP5 guideline of the ISPE (International Society for Pharmaceutical Engineering), including risk assessment and categorization of criticality. In software development, we rely on proven modules as well as the implementation of customer and application-specific features and requirements.

System qualification

E+K offers a comprehensive range of necessary documentation for system qualification. Based on a risk analysis, we create the qualification documents for your systems and carry out the document-based inspection. Direct qualification by our E+K experts enables shorter delivery times and offers an all-round carefree package for maximum reliability.

In addition to other procedures, standards, guidelines and laws, compliance with the cGMP guideline is an integral part of our working methods. We rely on GMP-compliant machine design that meets the highest quality standards to ensure that our solutions fulfil the requirements of the pharmaceutical industry. Our GMP services guarantee both a GMP-compliant development process and compliance with the strict specifications, guidelines, standards and laws of the industry.

 In parallel to the GMP guidelines, there are other guidelines that are considered best practice in the field of pharmaceutical manufacturing. Among these guidelines is GAMP, which stands for ‘Good Automated Manufacturing Practice’ and was published by the International Society for Pharmaceutical Engineering (ISPE). Our solutions are developed according to the process flow model of the V-model in accordance with GAMP5 and fulfil the requirements of cGMP (current Good Manufacturing Practice).

The E+K qualification process

Risk-based qualification is divided into four phases:

Design qualification (DQ): At this stage, we use the URS (User Requirement Specification) or the specification sheet to check whether the intended design and planned technical implementation meet the specified requirements.

Installation Qualification (IQ): This is where the installed system is checked in accordance with the previously defined design qualification.

Operational Qualification (OQ):  In this phase, the specific functions of the system are checked. The focus is on critical functions and the interaction of the various functions within the system. The actual state of the system is compared with the planned design state.

Performance qualification (PQ): This step is relevant for complex and interlinked technical systems and is the responsibility of our customers. Here, the performance of the system is tested under real conditions. GMP-compliant documentation is a crucial aspect in complying with the strict quality and safety standards in the pharmaceutical industry.

Our experts are at your disposal to ensure that your plants and systems meet the highest requirements and that qualification is carried out properly in accordance with GMP and GAMP guidelines. Contact us - we will be happy to advise you!