Process & Cleaning Validation
Are you looking for expertise in process and cleaning validation?
QbD offers a wide range of qualification and validation services for your processes, applications, and equipment. We have experts with knowledge of the entire validation and qualification field.
Don’t hesitate to contact us for more information.
Process & Cleaning Validation Services
Process validation is defined as the collection and evaluation of data, from development through to commercial production. It establishes scientific evidence that a process is capable of consistently delivering quality product and involves a series of activities taking place over the lifecycle of the product and process.
Process and cleaning validation does not only contribute to the safety and efficacy of medicinal products, it also helps to be compliant with regulations, reduce your production costs and improve the robustness and efficiency of your manufacturing process. It helps to determine the worst case and risks that may arise during the manufacturing of the quality products.Â
In other words, it is an essential part of the pharma industry to get a good, safe, and compliant product to patients.
Our experts can set up, improve and support the qualification and validation of your processes and cleaning.
What is Cleaning Validation?
Cleaning Validation is the process of confirming that cleaning procedures effectively and reproducibly remove residues and contaminants from equipment surfaces used in manufacturing processes. It involves systematic testing and documentation to ensure that cleaning methods consistently meet predetermined standards and regulatory requirements.Â
Cleaning validation does not only contribute to the safety and efficacy of medicinal products, it also helps to be compliant with regulations, reduce your production costs and improve the robustness and efficiency of your manufacturing process. It helps to determine the worst case and risks that may arise during the manufacturing of the quality products.Â
Cleaning Validation Essential to ensure:
- Product Quality: Proper cleaning validation ensures that your equipment is free from residues that could contaminate subsequent batches of your products, maintaining product purity and quality.Â
- Regulatory Compliance: Regulatory agencies require cleaning validation to ensure that manufacturing processes adhere to safety and quality standards, reducing the risk of product recalls or regulatory sanctions.Â
- Patient Safety: In industries such as pharmaceuticals and healthcare, cleaning validation is crucial for preventing cross-contamination and ensuring patient safety by eliminating the risk of exposure to harmful residues.Â
- Process Efficiency: Effective cleaning validation minimizes the risk of equipment malfunction or product contamination, reducing downtime and optimizing production efficiency.Â
Why QbD Group?
QbD can support existing teams or take the leading role in the following areas:
- Cleaning validation
- Process validation
- Method validation
- Equipment qualification
- Facility and utility qualification
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We guarantee that your products will meet quality demands and comply with the latest regulations in life sciences including ATMP, biotech, medical device, small molecule and generic products, resulting in a right first-time release and on-track project delivery.
Tailored solutions
The actual approach of this service is up to you. It is fully tailored to your needs.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.
