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Quality Control
Release Testing

Confirming Products Meet Specifications and Ensuring Safety

Quality Control (QC) Release Testing is key to ensuring your product has been manufactured correctly, is of appropriate quality and will produce the desired therapeutic effect for the end user. With over 15 years as a trusted provider of Quality Control (QC) Release Testing for regulated products, we are an ideal partner for your testing, inspection, and quality control needs.

 


three scientists in lab coats shaking hands

Our Efficient, Accurate QC Testing 

Ensuring you have the right partner to work with on your QC/batch release testing is critical to your business success. An experienced, efficient laboratory will positively impact your commercial operations and avoid unnecessary costs or delays.

Look for a partner with the experience to understand what matters to your business, and that can deliver the fast and efficient service you need. Ensure the company you choose emphasizes open communication, and thorough root cause analysis and investigation techniques for reporting and recording deviations. 

Our ethos is to ensure we can provide you with more than just the data.  We make sure we fully understand your business requirements so we can provide you with the information you need, when you need it, and in the format that you prefer.

 

Quality Control Release Testing at Broughton 

  • GMP certified/UKAS accredited laboratory with a robust Quality Management System (QMS)
  • Rapid turnarounds to meet your commercial timelines
  • Capacity for a high throughput of samples
  • Focused on communication and customer service
  • Access to a designated point of contact in the laboratory
  • Quick identification of atypical results
  • Quality-controlled sample handling processes
  • Scientific experts to help interpret deviations and atypical results
  • Raw data and record-keeping services
batch release testing taking place in a laboratory

Our Release Testing Services 

QC release testing starts once the analytical method validation or transfer has been completed and the relevant documents have been approved or with the identification of an appropriate Broughton platform method. All projects are assigned a dedicated point of contact within the laboratory to provide routine status updates and be available to your team for questions or issue resolution. We also use our Laboratory Information Management Software (LIMS) to ensure that all test data are reported promptly, and that raw data is retained and controlled securely.

We offer a fully integrated analytical testing service so the laboratory team can rely on input and advice from a wide range of scientific and regulatory experts if your project requires additional support.

Analytical method validation/transfer

Our team of highly experienced scientists will manage all aspects of your project needs, from feasibility and method assessment, through to validation and implementation.  Click here to learn more.

Batch testing

We perform batch testing for routine product release, APIs, clinical or pre-validation batches in line with your approved or draft specifications.


Expedited turnaround times are available to suit your business requirements.

Investigation management

Our dedicated team will quickly inform you of any atypical results and keep you informed of investigation progress.  Robust systems are in place for change control, deviations and effective CAPA management.

Results reporting in a format to meet your needs

We can provide results via Certificate of Analysis, detailing all test parameters or in other formats to suit your requirements e.g. spreadsheet reporting of data, formal written reports and statistical analysis of data.

Facility for controlled storage of your samples

We can store your samples in our on-site ICH stability storage facility and manage all aspect of your stability study. Click here to learn more.

Other Analytical Services

Broughton Method Development and Validation

Analytical Method Development and Validation

UHPLC and LC-MS method development, validation, and technology transfer with precision testing at ultra-low LOQ.

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Broughton Stability Storage QC

Stability Storage and Analysis

60,000 liters of purpose-built in-house stability storage capacity and full scientific analytical capabilities across chemistry, extractables and leachables studies, and toxicology. 

 

 

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Sample Handling

Efficient and high-quality sample shipping and handling services are essential to ensuring your batch release program stays on track to meet your commercial obligations. Our sample receipt, processing, and storage procedures are in line with GMP or ISO 17025 requirements for sample management. Laboratory teams are trained from day one on the importance of meeting client commitments, speedy communication, and acting as an extension of your in-house team.

Learn more about Shipping Samples by reading our Shipping FAQ. 

 

Plain brown box being picked up by woman wearing blue gloves and white lab coat
Broughton LIMS software on laptop at desk

Bespoke Record-Keeping Software

Real-time access to your QC release test data and trend reports through a secure and validated Laboratory Information Management System (LIMS) drives efficiency, ensures regulatory compliance, and provides data when needed. 

We record all test data in our bespoke LIMS (LabHQ), explicitly designed by our sister company, Broughton Software, to collate, store, and report analytical data. This system is designed and validated to meet the requirements of FDA 21 CFR part 11 and MHRA Annex 11 for electronic record keeping and signatures. 

Speak to an expert 

Speak with a QC release testing expert to discuss your business needs and learn how we can help your business succeed.



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Testing Services Resources

Learn more about how we can help bring your product to market through our high-quality analytical testing services.

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Pharma Inhalation Services

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A Guide To Pharmaceutical Marketing Authorisation in the UK

The MHRA is now a stand-alone body issuing national authorisations only. This infographic outlines the routes to a Pharmaceutical Marketing Authorisation in the UK.

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Toxicology-Advice-and-Consultancy-Services

Toxicology Advice and Consultancy Services

Our team of in-house toxicologists reviews and evaluates toxicological data on a wide range of chemicals to produce independent expert opinions on risk assessment. We then advise on the strategies to mitigate or reduce those risks to protect corporate reputation and public health.

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Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

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