GMP System Validation in SAP

Good Manufacturing Practice for pharmaceuticals and active ingredients efficiently implemented in SAP!

Your Requirements

  • Quality and risk management
  • Document management
  • Documentation of processes
  • Overview of handling with pharmaceuticals

Our Solution

  • Process documentation
  • Organisation
  • Transparency
  • Document management
  • Templates

Your Benefits

  • Full transparency over all processes
  • Sustainable documentation
  • Knowledge management
  • Increase of efficiency

The SERKEM Solution in Detail

GMP System Validation in SAP

GMP (Good Manufacturing Practice) refers to a form of ensuring that pharmaceuticals and active ingredients meet the highest quality standards and follow a targeted quality management system. A distinction is made between GMP and cGMP. GMP represents the quality requirements in Germany, while cGMP is the equivalent in the USA.

To comply with GMP requirements, your SAP system must have a comprehensive quality assurance system. Additionally, it should be fully documented and monitored.

First, a distinction must be made between qualification and validation:

Qualification

The qualification is the documented verification that the processes are all planned and installed according to valid rules and user requirements, and that they work.

Validation

The validation is the documented verification that a process is planned and executed according to valid rules and user requirements. The result has to be reproducible at any time.

The 4 validation phases

The design qualification is the documented verification that the design of the processes or of the system fulfills the requirements of the specification sheet, the GMP and the general quality assurance.

The following documents can be checked (an extract):

  • R & I schemes (rule and instrumentation schemes)
  • Process and facility description
  • Layouts
  • Specification sheets
  • Process flow diagrams

The installation qualification is the corresponding verification that the process, the system or the infrastructure are built and installed like the defined specifications, specification sheets and installation requirements.

The installation qualification should include the following (an extract):

  • Supplier audits
  • Data sheets
  • Inspection certificates
  • Material verifications
  • Operation and maintenance manuals

The operations qualification is the documented verification that the process or system works permanently, how specified, and can fulfill all the function requirements.

The following points have to be checked (an extract):

  • Interfaces
  • Normal functions
  • Manual functions

The performance qualification is the documented verification that the critical processes or critical systems, which were defined in the risk analysis, correspond reliably and permanently to a regulated process workflow.

V-model for quality assurance

For the validation of computer-based systems, a so-called V model is often used as reference model. The advantage is that this kind of model can be shown and used in many different forms. Though, this can lead to partially unclear and ambiguous presentations.

The v-model has its name through the characteristically presentation of the letter „v“. The left axis forms the different specification phases and the right axis the relative testing phases.

Therefore, the v-model is very suitable for the presentation of specification phases and the belonging testing phases as wells as for the appropriate adjustment to previously prepared specifications, user requirements and system specifications.

Phases of the v-model

At the user requirements, the process-oriented as well as operation-based requirements of the user or the process owner are registered:

Example

Process-based: Only certain users should receive the access to the system.

Operation-based: The system need to have a password protection according to a certain template.

At this document, the user requirements are further detailed and the appropriate operations specified.

Example

The user has to enter the user name and password in a modal dialogue field.

Also named design specifications, the technical requirements map the explanations for the developer how the system specifications have to be implemented. It´s specified, for example, which specific parts have to be deposited in the coding of a database table.

Are these phases completed and the first validation implemented, so the realization follows. Depending on the procedure, the appropriate tests will be executed. So the v-model in particular relation to GMP applies in both implementation steps DQ and IQ.

The most important guidelines and standards:

  • EG GMP-Leitfaden – Anhang 15 – Qualifizierung und Validierung
  • PIC/S PI 006-2 Recommendations on Validation Master Plan, Installation and Operation Qualification Non-Sterile Process Validation Cleaning Validation
  • Aide Memoire 0712 1104: Inspektion von Qualifizierung und Validierung in Pharmazeutische Herstellung und Qualitätskontrolle
  • ISO 14644, Teil 4
  • VDI 2083, Blatt 4.1, Blatt 11

If you need assistance at the validation of your SAP system, feel free to contact us.