GxP Qualification of Laboratory Equipment and Production Facilities

Qualifications and validations are essential components of quality assurance in regulated industries, particularly where processes must generate consistent, compliant, and traceable products in accordance with cGMP guidelines. The systematic evaluation of all process-relevant parameters, equipment components, and computer-supported systems is of fundamental importance for ensuring product quality and safety.

cube one GmbH possesses comprehensive expertise in GxP-compliant qualification and validation and supports you in implementing and executing risk-based validation strategies in line with current regulatory requirements.

Our Expertise:

Equipment and Room Qualification: As GMP experts, we support you in qualifying your production facilities, laboratory equipment, and clean rooms in accordance with GMP Annex 15. Our risk-based approach ensures efficient and regulatory-compliant implementation of all qualification phases.
Process Validation: We develop and implement tailored validation strategies for your critical processes, taking into account cGMP requirements and current regulatory standards. This includes process validation from initial process characterization to continuous process verification.
Computerized System Validation (CSV): From stand-alone applications to complex client-server architectures – we validate your computer-supported systems in accordance with GAMP 5, GMP Annex 11, and FDA 21 CFR Part 11. We utilize a category-based approach to determine the required validation scope.
Excelsheet Validation: For GxP-compliant use of Excel applications, we offer specialized validation services. This includes developing validated templates and implementing control functions to ensure data integrity in accordance with ALCOA+ principles.
Lifecycle Management through your Validation Manager: Sustainable lifecycle management is the key to lasting compliance. Our Validation Manager proactively supports you in maintaining the validated state of your systems and processes. Through structured periodic reviews, precise change impact analyses, and expertly executed re-qualifications, the Validation Manager ensures that your operations consistently meet regulatory requirements, even as changes occur.
Change Control: As part of an integrated change management system, we accompany system changes from initial risk assessment to final documentation. We ensure compliance with regulatory requirements for documentation quality and traceability.

Your Strategic Advantage:

The strategic partnership with cube one GmbH in qualification and validation secures you the following decisive competitive advantages:

Maximum GxP Compliance: We ensure comprehensive adherence to all relevant regulations (GMP, Annex 11/15, 21 CFR Part 11) for your facilities, processes, computer-supported systems (CSV), and critical Excel applications.
Focus on Core Competencies: Relieving your internal resources by taking over time-intensive, specialized tasks – gain space for research, development, and value creation.
Increased Process Efficiency: By accompanying qualified experts, inefficiencies are minimized and processes streamlined.
Risk-Based Approach: Proactive identification and mitigation of quality-relevant risks minimizes the probability of deviations, non-compliance, and associated costs.
Accelerated Market Introduction: Efficient validation processes enable faster time-to-market for your products.
Audit and Inspection Security: Comprehensive, GMP-compliant documentation of all qualification and validation activities creates transparency and security during regulatory inspections and customer audits.
Sustainable Quality Assurance: Implementation of robust processes and systems to maintain the validated state throughout the entire lifecycle.
Competitive Advantage: Increase your reputation through validated processes and systems.

Validation Documents

We Create the Qualification and Validation Documents You Need
Validation Master Plan (VMP), which establishes the overarching validation strategy, responsibilities, schedule, and fundamental principles and scope of validation activities. This document serves as the basis for all subsequent GxP-relevant validation activities.
User Requirements Specification (URS), which lists all requirements for the system to be qualified/validated. Considers technical standards, general, functional, and process requirements.
Qualification Documents (DQ, IQ, OQ, PQ), which provide systematic evidence of the correct Design Review, Installation, Operation, and Performance of the system. These four qualification phases form the basis for documented proof of compliance.
Risk Analysis (RA), which lists and evaluates all risks concerning the system and process. The risk analysis is created according to common risk analysis methods, such as FMEA (Failure Mode and Effects Analysis).
Validation Summary Report (VSR), which, as a final document, summarizes all validation activities, evaluates the results, and documents the formal closure of the validation. This report serves as evidence of GMP compliance.
Standard Operating Procedure (SOP), which describes in detail as a standardized work instruction how specific processes and activities are to be executed. It ensures the reproducibility of workflows under GMP-compliant conditions and establishes responsibilities and required documentation.
And many other documents.

DQ/IQ/OQ/PQ

We conduct all necessary qualification/validation phases in accordance with GMP requirements and GAMP 5. This includes creating risk-based test cases, final documentation, and execution either remotely or on-site, taking into account SOPs and cGMP guidelines.
DQ – Design Qualification: In the DQ, the specification is reviewed against the User Requirements (URS) and it is documented that the design meets regulatory requirements.
IQ – Installation Qualification: The IQ verifies and documents that all system components have been correctly installed according to the technical specification and that the installation environment meets the defined requirements.
OQ – Operational Qualification: In the OQ, all functional specifications are tested under controlled conditions and it is demonstrated that the system operates reliably within the established operating parameters.
PQ – Performance Qualification: The PQ demonstrates the system’s suitability in routine operation under real production conditions and verifies process reproducibility.

Excelsheet Validation / Life Cycle

We support you in the GxP-compliant use of Excel spreadsheets in regulated environments.
Both the development and validation of Excel spreadsheets are part of our repertoire.
We ensure that your system remains in its qualified/validated state throughout its entire lifecycle.
This includes, among other things, change control, conducting requalification and revalidation, as well as support for all lifecycle activities such as user and audit trail reviews and decommissioning.

FAQ on the Qualification of Facilities and Laboratory Equipment in the GxP Environment

What is the difference between qualification and validation?

Qualification refers to equipment, facilities, and utilities, while validation refers to processes and methods. Qualification is the documented evidence that equipment is properly installed, functions correctly, and actually leads to the expected results. Validation confirms that a process (using the qualified equipment) consistently meets quality requirements.

What are the four phases of qualification (IQ, OQ, PQ)?

Qualification is typically divided into four phases:

Design Qualification (DQ): Documented evidence that the design of the facility/equipment is suitable for the intended use.
Installation Qualification (IQ): Documented evidence that the facility/equipment has been delivered according to the manufacturer’s specifications or user requirements and has been correctly installed.
Operational Qualification (OQ): Documented evidence that the facility/equipment operates within the specified operating and specification limits.
Performance Qualification (PQ): Documented evidence that the facility/equipment operates consistently and reproducibly under normal operating conditions.

What is the DQ process (Design Qualification) and when is it performed?

DQ is the first phase and is performed before the purchase or construction of the facility/equipment. It ensures that the URS (User Requirement Specification) – the user requirements – have been transferred into the design of the facility and that regulatory requirements can be met.

What documents are typically necessary for IQ (Installation Qualification)?

For IQ, the following are required, among others:

Review of delivery documentation (delivery notes, manuals).
Verification of correct installation (connections, cabling, location).
Comparison with drawings and diagrams (e.g., P&ID).
Calibration certificates of measuring instruments.

What critical aspects are tested during OQ (Operational Qualification)?

OQ includes testing all functional aspects of the facility/equipment under „worst-case“ conditions. Critical parameters tested include:

Functionality of the control system (e.g., alarm limits, safety shutdowns).
Compliance with operating parameters (e.g., temperature range, pressure limits).
Function of the safety system.

What is the focus of PQ (Performance Qualification)?

PQ is the proof that the facility/equipment consistently delivers the expected performance under real production or laboratory conditions over an extended period of time. Typically, multiple runs/batches are tested to demonstrate reproducibility and consistency.

What happens if a facility needs to be modified after qualification?

Any change that could affect the qualified parameters or the integrity of the facility must be managed through a formal change control process. The change is assessed, and it is determined whether a re-qualification (repeated IQ, OQ and/or PQ) is necessary to ensure ongoing compliance.

How long are qualifications valid and what does re-qualification mean?

Qualifications are not necessarily time-limited, but remain valid as long as the qualified state of the facility/equipment remains unchanged. Re-qualification or periodic review is, however, required to confirm that the equipment continues to function according to requirements, especially after major changes, relocations, or after a certain period of use.

What is the purpose of a calibration plan?

A calibration plan specifies that all measuring instruments (e.g., thermometers, pressure sensors, scales) that affect quality are regularly calibrated to ensure their accuracy. Only calibrated measuring equipment may be used for qualification and GxP operations. Calibration must be traceable to internationally recognized standards.

Who is responsible for the qualification?

The responsibility ultimately lies with the facility or equipment operator (the end user). However, the execution of the qualification is often carried out by a team consisting of: