Expertise.
Process validation.
Compliant?
Efficient?
Reliable?
Validated manufacturing processes for regulated industries.
Sound process validation is required by law in pharmaceutical and biotechnological production (GMP) - and is essential in medical technology in accordance with ISO 13485. The following applies in all cases: only validated processes guarantee consistent quality, product safety and approvability.
Our services are based on internationally recognized standards such as EU GMP, FDA 21 CFR and ISO 13485. Whether IQ/OQ/PQ for automated systems or risk-based validation of manual processes - we ensure that your processes are regulatory compliant and technically robust.
You benefit from our experience in validation strategy, qualification and audit preparation - in close coordination with your internal QA, engineering and regulatory teams - particularly for complex technologies such as filling processes, sterile packaging or active ingredient production.
Ensure your regulatory compliance with our process validation.
Process validation - structured, risk-based & documented.
Planning and risk assessment.
- Analysis of critical process steps and risk factors
- Development of a GMP or ISO-compliant validation strategy
- Definition of valid test criteria and target parameters
IQ/OQ/PQ & risk-based qualification.
- IQ: Installation qualification of technical systems
- OQ: Function test under specified conditions
- PQ: Proof of performance in real operation (e.g. for automated lines)
- Risk-based alternatives for manual or semi-automated processes
Documentation and audit preparation.
- Creation of complete validation documents and reports
- Integration into existing SOP structures
- Support for inspections by authorities and internal audits
Practical examples from pharma, biotech and medical technology.
Challenge.
A pharmaceutical company wanted to get new production lines up and running quickly while meeting all GMP requirements. customer requirements.Measures.
- Development of a complete validation strategy
- Implementation of structured IQ/OQ/PQ
- Cooperation with engineering and QA
Results.
- On-schedule commissioning without delay
- GMP-compliant processes from day one
- Successful initial inspection by the authorities.
Success.
Fast market launch through auditable processes.Validate your processes in accordance with GMP and ISO 13485.
Our service for valid manufacturing processes - flexible, regulatory safe, auditable.
We analyze your processes and develop an individual validation strategy tailored to your product, industry and risk profile.
For automated or critical processes, we carry out complete IQ/OQ/PQ. For manual processes, we use risk-based validation approaches.
We provide structured documentation suitable for use by the authorities and support you with audits, follow-up and re-validation.
Validation does not end with the last test: We support you with revalidation, review cycles and adaptation to new regulatory requirements.
We identify potential for improvement, optimize your processes and prepare the necessary documentation for certification.
With preventive risk management, we ensure the continuous monitoring of critical process steps in order to guarantee quality in the long term. Further information on risk management can be found on the ISO 9001 principles page.
We advise you on the selection of a suitable certification body and support you throughout the entire certification process.