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Qualification

Our qualification services ensure that pharmaceutical systems and facilities meet regulatory requirements and are optimally prepared for operation. With a structured approach, we support you through all phases – from planning to final acceptance.

FROM REQUIREMENTS TO SUCCESSFUL FINAL ACCEPTANCE

Structured Qualification – From Requirements to Operation

The qualification of pharmaceutical systems and facilities is a central component for ensuring quality, compliance, and product safety. At the same time, the process is complex: various requirements, numerous documents, and clearly defined testing phases must logically build upon each other and be implemented comprehensibly.
Our qualification approach follows a structured, risk-based procedure and supports you from the initial requirement definition to successful commissioning and requalification during ongoing operation.

V-Model of Qualification

A qualification is divided into several phases, which are described in this chapter. The phases build upon each other and should therefore proceed sequentially. For this reason, a formal release for the subsequent steps is generally required after the completion of each qualification step.
V-Modell Qualifizierungsdiagramm V-Modell mit URS, FS, DS, Umsetzung, IQ, OQ, PQ, RQ und Verifikationspfeilen sowie DQ-Klammer DQ. Designqualifizierung URS Nutzeranforderungen FS Funktionsspezifikation DS Designspezifikation Umsetzung evtl. mit FAT, SAT IQ Installationsqualifizierung OQ Funktionsqualifizierung PQ Leistungsqualifizierung RQ Requalifizierung verifiziert verifiziert verifiziert Erstqualifizierung Requalifizierung im Lifecycle

Design Qualification

Design Qualification demonstrates that the planned system complies with GMP requirements and user requirements. User Requirement Specifications (URS) and specifications are reconciled with the planned design. The design is typically released upon completion of the DQ.

User Requirements

The URS defines all requirements for the pharmaceutical system from the user’s perspective. It is based on the intended use, considering GMP, safety, and quality aspects. The URS forms the basis for all further specifications and qualification steps.

Functional Specification

The Functional Specification concretizes the requirements described in the URS and defines which functions the system must fulfill. It serves as the basis for deriving tests and acceptance criteria in subsequent qualification phases.

Design Specification

The Design Specification describes the technical implementation of the functional requirements. It defines the structure, components, and technical design of the system and ensures that the design meets the defined requirements.

Implementation

Implementation includes the setup, installation, and commissioning of the system based on the approved design. Optionally, FAT and SAT tests accompany this step for early quality assurance.

Installation Qualification

IQ confirms that the system has been installed according to approved drawings and specifications. Installation, materials, documentation, calibrations, as well as mechanical and electrical execution are checked, among other things.

Operational Qualification

OQ demonstrates that the system functions correctly within defined operating limits. Safety functions, operating modes, monitoring and interface functions, as well as operational documentation and personnel training, are checked.

Performance Qualification

PQ proves that the system operates reproducibly and according to specifications in real operation and in conjunction with adjacent systems. This demonstrates performance under practical conditions.

Requalification

Requalification ensures that a qualified system continues to meet the defined requirements throughout its lifecycle. Scope and frequency are determined on a risk-based approach, e.g., in case of changes or after defined time intervals.

The phases presented form the basis for our qualification support services.

Our Services at a Glance

Quality Management Plans

Detailed planning of quality-relevant measures to ensure compliance

Document Creation

Creation and review of all qualification-relevant documents – User Requirement Specifications (URS), functional specifications, and Standard Operating Procedures (SOPs).

Risk Analysis & Assessment

Identification and assessment of potential risks to ensure stable and safe operation

Qualification Plans

We support all qualification phases (DQ, IQ, OQ, and PQ), including design review, and ensure seamless documentation

Change Management

Structured assessment and implementation of changes to continuously ensure compliance and process stability

Your Benefits with DPhE

Quality Assurance

GMP-compliant implementation guaranteed

Traceability

Structured, auditable documentation

Expertise

Technical and regulatory expertise

Process Orientation

Efficient processes through risk orientation