Is an audit coming up, have deficiencies in your cleaning validation been identified, or do you need to introduce new products on multi-purpose equipment? We support you with practical solutions.

Your cleaning validation no longer meets current requirements

Your existing cleaning validation still relies on the 1/1000 rule or other outdated limit calculations. This has been flagged as a deficiency in an audit or self-inspection.

• The risk: During regulatory inspections, the lack of a toxicological rationale for the limits is considered a critical deviation. In the worst case, a production stop may be imposed.
• Our solution: We perform a gap analysis of your existing validations, calculate PDE-based limits in line with the current EMA guideline, and systematically update your documentation.

Introduction of a new product on a multi-purpose facility

You want to manufacture a new medicinal product on existing equipment that is also used for other products. The cleaning validation needs to be extended accordingly.

• The risk: Without validated cleaning processes for the new product, batch release is not possible. Market launch is delayed.
• Our solution: We assess whether the new product can be assigned to an existing product group or whether a separate validation is required. We calculate the new limits, adapt your validation documentation, and support the validation execution.

Analytical methods are not validated

The analytical methods for your cleaning samples have never been formally validated. Recovery rates for swab samples are not documented.

• The risk: Without validated analytical methods, your cleaning validation results are not meaningful. Inspectors will question the validity of the entire cleaning validation.
• Our solution: We support you with method validation, perform recovery studies, and document that your analytical methods are fit for their intended purpose.

Are you facing these or other challenges in cleaning validation? Speak to us: The initial consultation is free of charge.

Are you planning a cleaning validation, or do you need to update existing validations? We are at your side to make sure your cleaning validation meets all regulatory requirements.

How QP-Engineering supports you with cleaning validation:

• Tailored concept and strategy development: We develop bespoke cleaning validation concepts that take your specific equipment, products, and processes into account and meet current regulatory requirements.
• Scientifically sound limit calculation: We calculate health-based acceptance criteria in line with the EMA guideline and document the rationale in a fully traceable way.
• Practical sampling strategies: We define critical sampling locations, develop suitable swab and rinse methods, and validate recovery rates.
• End-to-end project management: Our team coordinates all stakeholders, monitors validation progress, and ensures on-time delivery in line with your objectives.
• GMP training on cleaning validation: Our team offers dedicated training so your staff understand the requirements of cleaning validation and apply them correctly.

QP-Engineering understands the specific requirements of cleaning validation in the pharmaceutical industry. Our expert team has years of experience validating cleaning processes for solid and liquid dosage forms, sterile and non-sterile products, and highly potent active ingredients (HAPI). We support pharmaceutical companies in every aspect of cleaning validation: from the initial concept development through sampling to audit-ready documentation.