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PROCESS VALIDATION SERVICES

Specialists in Process Validation

Bio Products Validation Limited (BPV Limited) is a provider of process validation services and specialists, offering comprehensive solutions for life science manufacturers in the UK, Ireland, and beyond. Our team of highly skilled validation engineers and consultants have expertise in validating processes across a range of pharmaceutical and biotechnology facilities, ensuring consistent quality and regulatory compliance.

BPV Limited utilises extensive process validation protocols and robust data collection methodologies to demonstrate a process’s ability to consistently deliver a product that meets its pre-determined specifications and quality attributes through every critical manufacturing step.

BPV Limited provides fully customisable process validation solutions tailored to the unique needs of life science clients. Our unwavering focus on quality and process control provides clients with confidence that their manufacturing processes will consistently produce a product meeting its pre-determined specification and quality attributes, enabling them to bring life-changing treatments to market efficiently and safely.

In addition to process validation, BPV Limited offers a comprehensive range of validation services, including equipment validation, cleaning validation, and computer system validation, ensuring compliance and quality across all aspects of pharmaceutical manufacturing. Our experienced validation specialists work closely with clients to develop and implement tailored validation strategies, leveraging industry best practices and regulatory guidelines.

BPV offers process validation services and provides process specialists and engineers in the UK and Ireland

With products having a short shelf life, process validation becomes even more crucial. Depending on the product specifications, we can evaluate critical parameters such as pH, temperature, purity, and product weight variation throughout the production process. This ensures they remain within validated ranges. Our proactive approach allows us to quickly identify and correct any deviations, ensuring the highest product quality and regulatory compliance.

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What are Process Validation Services?

Process validation documents and demonstrates that a specific process consistently produces a product that meets its predetermined specifications and quality attributes. By proving that the process works reliably and repeatedly, businesses can qualify that their products are safe, effective, and consistently meet quality standards.

To take advantage of our team’s expertise in process validation, reach out to us today to discuss your needs or request a quote.

The Importance of Process Validation

Process validation is essential for ensuring product quality and consumer or patient safety, especially in industries such as pharmaceuticals and biotechnology. Process validation also helps businesses to comply with relevant regulatory requirements for their industry and reduces the risk of product recalls, defects, and production failures.

Process Validation Sectors

Process validation services are imperative for any business that manufactures products that require strict quality, safety, and regulatory compliance. We provide commercial process validation services to a wide range of business types, including the following:

Pharmaceutical Manufacturers

We offer our validation services to pharmaceutical manufacturers in accordance with MHRA, EU GMP, and ICH guidelines.

Biotechnology Companies

Businesses involved in biologic drugs, monoclonal antibodies, ATMPs, DNA and RNA sequencing, recombinant proteins, cell and gene therapies, and vaccines can benefit from our biotechnology process validation services.

Medical Device Manufacturers

Our medical device manufacturing process validation services include validating the processes involved in the manufacture of diagnostic devices, implants, surgical instruments, and combination products in accordance with UK MDR 2002, ISO 13485, and EU MDR where applicable.

Benefits of Process Validation Services

Regulatory Compliance

Our services can help to ensure your alignment with various regulatory requirements and international standards, helping your company to remain audit-ready and minimising your risk of non-conformance findings during inspections.

Cost Efficiency and Sustainability

By identifying process issues early, your business can avoid costly rework or recalls. By optimising your manufacturing process, process validation can help you to reduce your use of materials and improve your energy efficiency.

Quality and Safety

Process validation ensures the quality and safety of your products, reducing the likelihood of batch failures, contamination, or variability.

Knowledge and Control

Process validation improves your knowledge of critical process parameters and quality attributes, allowing for better control and risk management going forwards.

Our Process Validation Services

Bio Products Validation Limited (BPV Limited) is a provider of process validation services and specialists, offering comprehensive solutions for life science manufacturers in the UK, Ireland, and beyond.

BPV Limited utilises extensive process validation protocols and robust data collection methodologies to demonstrate a process’s ability to consistently deliver a product that meets its pre-determined specifications and quality attributes through every critical manufacturing step.

BPV Limited provides fully customisable process validation solutions tailored to the unique needs of life science clients. Our unwavering focus on quality and process control provides clients with confidence that their manufacturing processes will consistently produce a product meeting its pre-determined specification and quality attributes, enabling them to bring life-changing treatments to market efficiently and safely.

How to Arrange Our Process Validation Services

To take advantage of our team’s expertise in process validation, you can reach out to us today to discuss your needs or request a quote by either filling in our online form, sending us an email at [email protected],
or calling us on 01293 405147.

Why Choose BPV?

Bio Products Validation Ltd (BPV) was established to offer the best level of validation services within the UK and Ireland life science industry. With a dedicated team of validation engineers and consultants, BPV’s team has provided services to the life science industry since 2005.

As a company, our engineers have over 100 years of combined industry experience working on a variety of validation projects, small and large, across the pharmaceutical and life science sectors. We understand that every company’s needs are different, so we will work with you to achieve your desired goals and outcomes efficiently.

Our experienced validation engineers can reduce your project timelines and overall costs by streamlining your processes and we can quickly scale our resources to meet your changing demands. BPV is a trusted name in the industry; our team is fully versed in cGMP and GxP regulations and boasts an unwavering commitment to excellence and customer satisfaction which truly sets us apart.

If you are interested in working with us or learning more about our services, get in touch with us today to request a quote or to discuss your needs with a member of our friendly and knowledgeable team.

Frequently Asked Questions (FAQs)

What are the stages of process validation?

Process validation involves three key stages:

  1. Process design – defining and developing the manufacturing process, including identifying critical quality attributes and critical process parameters
  2. Process qualification – this is often done by manufacturing and testing a number of production-scale batches to confirm the processes ability to consistently produce a product of the required quality
  3. Continued verification – ongoing monitoring and control to ensure the process remains under control during routine production

Is process validation mandatory in the UK?

Process verification is compulsory for regulated industries, with MHRA and EU GMP both requiring documented process validation.

Do you offer custom process validation?

Our process validation services are entirely bespoke and tailored to each client’s process, product, and regulatory requirements.

Can you help during technology transfer or scale-up?

We support validation throughout tech transfer phases to ensure smooth transitions and regulatory compliance.

Do you provide validation documentation and reports?

According to your preferences, we can deliver full validation documentation, including protocols, reports, risk assessments, and SOPs. All of our documentation aligns with with MHRA, EU GMP, and GxP expectations.

How do I get started with working with BPV?

You can contact us via email at [email protected], call 01293 405147, or use our online form to request a quote or consultation.