Validation

Validation is the key component of good manufacturing practice

Validation is a central GMP requirement and an essential part of quality assurance. Valicare offers a comprehensive service for GMP-compliant process validation.

Validation is an essential part of the good manufacturing practice (GMP) and assures that the production process is reproducible and the specifications of the drug products or medical devices are continuously in compliance.

Valicare GmbH offers comprehensive service for GMP-compliant validation of:

  • Production processes (process validation, PV)
  • Cleaning processes (cleaning validation, CV)
  • Analytical methods (analytical method validation, AMV)
  • Computer-based systems (computer system validation, CSV)

Our validation plans and protocols contain defined test methods and acceptance criteria and will be prepared in agreement with the customer. Our validation reports document the results of the validation runs and check the compliance with the specifications. A follow-up of the deviations, their GMP-compliant documentation and handling through change control system complete our validation process.

  • Validation master plan

    The validation master plan (VMP) of Valicare follows the official requirements of the current GMP guidelines, describes the qualification and validation procedure and generates a schedule as a fundamental basis for the planning of your validation project. In addition, we identify in a risk-based approach the critical process parts and equipment as well as facilities and utilities which have impact on the product quality and must be qualified and validated successfully before starting the routine production.

    The VMP contains:

    • Qualification and validation policy
    • General qualification and validation strategy and procedure
    • Structure of the organization and responsibilities for the qualification and validation project
    • Summary of the facilities, equipment, systems, processes and their qualification and validation status
    • Definition of the required qualification and validation protocols and their structure
    • Determination of a deviation and change control management
    • Guidelines for development of acceptance criteria
    • Cross-reference list to already existing documents and SOPs
    • Time schedule and resource planning

    The VMP demonstrates that the validation approach of your company is thoroughly in GMP compliance.

  • Process validation

    Process validation ensures that the process fulfills all specific requirements and acceptance criteria during routine production with a high level of reproducibility.

    Successful qualification of the equipment and facilities is a part of prerequisites for process validation which is an evidence that the design, installation, operation and performance fulfill the GMP requirements of the manufacturing process.

    Our process validation scope:

    • Determination of critical quality attributes (CQA) and critical process parameter (CPP) as well as their acceptance criteria in accordance with current guidelines, authorization documentation and process risk assessment
    • Evaluation of all test results from production, in process controls (IPC) and the quality control of the finished product
    • Evaluation of the monitoring results coming from sterile media systems, utilities and clean rooms
    • Follow-up of the deviations and their GMP-compliant handling and documentation
  • Change control

    Changes made to the validation process must be clearly documented and commented.

    Changes on critical aspects like starting material (including packaging material), intermediate products, procedures and process parameters, equipment and environmental conditions, design space and process control may have an impact on process reproducibility or product quality. Therefore, the control of changes is an important part of any quality assurance system.

    The Valicare GmbH can follow up the scheduled changes and discuss the mandatory regulatory requirements to check the necessity of tasks like rebuilding, requalification and/or revalidation.

  • Revalidation

    In the GMP guidelines regular revalidation of critical processes is required. On the basis of the initial validation, critical parameters are therefore rechecked at appropriate time intervals, often with a reduced scope. The Valicare GmbH offers comprehensive GMP-compliant revalidation support.

    Valicare services:

    • Revalidation of cleaning in place (CIP) and sterilisation in place (SIP) processes
    • Revalidation of decontamination cycles in isolators and active airlock systems
    • Revalidation of aseptic filling processes by “media-fill”

    The results of the validation are recorded in a GMP-compliant documentation in form of plans and reports. Deviations are documented according to your deviation management requirements and suggestions for remediation are submitted.

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Contact us if you have any questions. We will gladly answer and advise you.