GMP Qualification

Quality from the beginning

Particularly in the pharmaceutical, food and chemical sectors, GMP-compliant production plays a central role. In order to meet the high standards and guidelines for hygiene, premises and equipment, we develop customized measures for quality assurance. We create all relevant qualification and validation documents as well as work instructions to guarantee a constant product quality and to avoid misinterpretations. Only after a defect-free acceptance by your qualification department and our GMP experts, the automation system will start to operate. For systematic qualification, we use the V-model. Your advantage: The well-thought-out qualification process saves you time and costs and minimizes your risk in terms of product liability.

Implementation Risk Management

In most of our customer projects we prepare the risk assessment according to the FMEA method (Failure Mode and Effects Analysis). FMEA has been recognized as a DIN standard since 1980 (DIN 25448, since 2006 DIN EN 60812).

We carry out the evaluation of risk groups and risk ratios in our office as a proposal. In cooperation with the client, these key figures are then discussed and approved. This ensures the “four-eyes principle” required by GMP.

Preparation of Specification sheet

The specification sheet defines the requirements for the project. It is presented in tabular form. Here, we pay strict attention to clear requirements, as these serve as the basis for the qualification or test documents in the further course of the GMP qualification and are traced back in the traceability matrix.

Furthermore, the roles of the project participants are also defined with the preparation of the specifications (Who defines? Who operates? Who tests? Who releases?).

Preparation & Performance of FAT, SAT

The FAT represents an important milestone in the overall schedule of the project.

For us, the FAT (Factory Acceptance Test) is an important test in the project, because this is where our customer gives his approval to the supplier that the tested plant part or machine may be delivered to the construction site. This ensures that no “semi-finished” components are delivered.

In the SAT (Site Acceptance Test) we then check that everything has arrived on the construction site undamaged. Any points resulting from minor defects in the FAT test are immediately checked.

Preparation & Performance DQ, IQ, OQ

The DQ (Design Qualification) represents the conclusion of the planning phase. After that, construction can and may take place. The automation technology divides DQ into two phases: HDS (hardware design qualification) and SDS (software design qualification).

With the preparation and performance of the IQ (Installation Qualification), we test all components that are testable at the end of the assembly phase. These are, for example, material certificates, FDA certificates or the correct assembly of vessels and pipelines.
But there is also a lot to check in the field of automation technology, such as control cabinet, circuit diagram, EMC-compliant cabling, fire protection bushings, compressed air supply, and so on.

Within the scope of OQ (Operation Qualification), we check all GMP-relevant functions of the plant. These are, for example: Emergency stop, dosing, heating, stirring, cooling, circulation, and so on.

In addition, all requirements resulting from 21 CFR Part 11 or EU GMP Annex 11 are checked as part of the OQ. This includes points such as user registration, domain functions, password aging, long-term archiving, electronic signature, etc.

Computerized system validation

“Prospective Computerized system validation” means that we validate the computer system for the first time before it goes into productive use.

When performing the “Revalidation” or “Periodic Review”, we check the computer system after a period of time specified in the validation master plan that the requirements from the system installation are still being operated unchanged. If deviations have occurred, these are documented and integrated into the life cycle of the system in a GMP-compliant manner.

A “retrospective Computerized system validation”, i.e. after the computer system has already been put into productive use, is no longer required according to GAMP 5.

Categorization according to GAMP 5

GAMP 5 provides several software categories for the classification of a computerized system. By correctly classifying the new software systems, the validation effort for the overall system can be reduced considerably.

We carry out an initial classification of the software systems in our office as a proposal. These software categories are then discussed and approved in cooperation with the customer. This ensures the “four-eyes principle” required by GMP.

Maintenance of the valid state

In order to maintain the valid state of a pharmaceutical plant, recurring activities are necessary that extend over the entire life cycle of the plant.

The tasks to be performed include, for example, the check that:

• the last implemented changes / modifications are recorded in accordance with GMP,
• the maintenance cards have been processed,
• the SOPs are up to date,
• the employees are trained,
• the user administration is up to date,
• the times of all installations and subsystems are set correctly and identically,
• the full function of long-term data archiving is given,

as well as the performance of an audit trail review.