Broughton Laboratories Ltd.

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The Way We Do Things Makes A Difference

Passionate. If we had to choose one word to describe our approach that would be it. We pride ourselves on offering the best analytical services available to the healthcare industry. We are an independent business, which means you benefit from our drive, expertise and fresh perspective. We offer a bespoke and high quality service, allowing you to concentrate on your core business activities and what you do best. The people we are and how we do things makes a tangible difference. Put simply, we are your laboratory.

Broughton Laboratories is an independent analytical testing laboratory focused on assisting veterinary, pharmaceutical and healthcare companies achieve their regulatory registration goals and post-registration product release testing. This is achieved through our extensive analytical testing and support services.

 

Pharmaceutical Testing

Broughton Laboratories Ltd. specialise in offering GMP compliant pharmaceutical testing services and our facilities are regularly inspected by the MHRA (Medicines and Healthcare Regulatory Authority). We have the ability to perform a vast array of analysis on pharmaceutical finished products, raw materials and other ingredients, from a variety of compendiums.

These include:

* The European Pharmacopoeia (EP)
* The British Pharmacopoeia (BP)
* The United States Pharmacopoeia (USP)
* The Japanese Pharmacopoeia (JP)
* The Association of Analytical Communities (AOAC International)
* The American Oil Chemists’ Society (AOCS)

QC Batch Release Testing

Broughton Laboratories is a MHRA-inspected facility that meets or exceeds all compliance standards for conducting QC release testing in compliance with GMP regulations. Our state-of-the-art systems for sample registration, testing and report generation, ensure our customers continuously receive a fast, reliable and high quality service. We always solve problems quickly and accurately, backed up by clear communication with clients. As a result, our clients always receive the best possible level of service and professionalism to meet their QC release testing needs.

 

 

Some of our key features include:

* Complete client confidentiality
* MHRA registered for cGMP regulatory compliance
* Tailored LIMS system validated to customers specifications
* Tailored Analysis Request Forms (ARFs) for submitting samples
* Fast and reliable turnaround times to meet your supply chain requirements
* Premium service and excellent value for money

Test Method Development

Broughton Laboratories has extensive experience in developing and validating analytical test methods for various applications and across a variety of product types in compliance with international regulations. Our analytical team have expertise in developing analytical methods in the following key areas:

* Efficient and robust QC test methods
* Stability indicating test methods in compliance with ICH guidelines
* Methods for cleaning validation studies
* Dissolution and drug-profiling methods
* Compendial methods specific to your products

The dosage forms on which we work include:

* Solid dose: tablets, hard gelatin capsules, granules, powders and medicated feeds
* Liquids: oral and topical liquids, suspensions and emulsions
* Semi-solids: creams, ointments and gels
* Medical devices

Broughton Laboratories can assist throughout the entire method development and validation activity to meet your requirements. This includes project planning, protocol writing, execution and final development report to satisfy your regulatory needs.

Test Method Validation

Broughton Laboratories has extensive experience in test method development and validating analytical test methods for various applications and across a variety of product types in compliance with international regulations. Our analytical teams have particular expertise in method validation and developing analytical methods in the following key areas:

* Efficient and robust QC test methods
* Stability indicating test methods in compliance with ICH guidelines
* Methods for cleaning validation studies
* Dissolution and drug-profiling methods
* Compendial methods specific to your products

We will also gladly support you in technology transfer validation projects.

Broughton Laboratories can assist throughout the entire method validation activity to meet your requirements. This includes project planning, protocol writing, execution, statistical evaluation and final validation report writing to satisfy your regulatory needs.

Stability Studies

Broughton Laboratories has fully-qualified stability room systems and is capable of providing the controlled temperature and humidity climatic conditions specified in the ICH/VICH guidelines for long-term, intermediate and accelerated stability storage trials.

Current standard ICH/VICH conditions are:

* 25ºC/60%RH
* 30ºC/65%RH
* 40ºC/75%RH

In addition, Broughton Laboratories can provide stability storage solutions for a client’s specific requirements.

In offering stability indicating test method development and validation, we can support you through the stability storage and stability testing programme.

Dissolution Studies

Dissolution is a critical parameter of pharmaceutical dosage forms. It is well recognised that in-vitro dissolution testing is relied upon to screen formulations during development and to ensure batch-to-batch quality control during routine release testing.

Dissolution is the process by which a solid solute with relatively low solubility enters into solution in the presence of solvent. Dissolution rate may be defined as the amount of active ingredient in a solid dosage form dissolved in unit time under standardised conditions of liquid/solid interface, temperature and media composition.

Broughton Laboratories has invested in state-of-the-art dissolution apparatus that meets the requirements of international regulations. Together with our extensive experience in developing and validating dissolution test methods, for various applications and across a variety of product types, we are confident that we can meet your expectations.

Product Formulation

Broughton Laboratories work with clients to develop and optimise formulations to progress products to manufacture. We recognise the critical importance of working with you to reduce the time between drug discovery and commercialisation.

We offer a complete range of formulation development services including:

* Pre-formulation assessments
* Formulation of a wide variety of dosage forms
* Laboratory-scale pilot batches
* Test method development and validation
* Stability storage and testing

We work on new active substances, generics and the reformulation of existing products to meet your requirements. The dosage forms on which we work include:

* Solid Dose: tablets, hard gelatin capsules, granules and powders
* Liquids: oral and topical liquids, suspensions and emulsions
* Semi-solids: creams, ointments and gels
* Medical devices

Technical Projects

Broughton Laboratories has extensive analytical testing and technical support services to assist pharmaceutical and healthcare clients achieve their regulatory registration goals and technical troubleshooting. We always solve problems quickly and accurately, backed up by clear communication with clients.

Our team of skilled and knowledgeable scientists are focused on meeting your expectations through:

* excellence in project management
* flexible supply contracts
* delivery on our promises

 

Statistical Analysis

Broughton Laboratories understand that analytical measurements should be made to satisfy the agreed requirement. This is why many of our clients benefit from our data evaluation service which includes using Six Sigma methodology. Some of the statistical techniques used to analyse data includes:

* Gauge R&R (Measurement System Evaluation)
* Components of variation (COV) assessment
* Process capability
* Statistical process control (SPC) charts
* Hypothesis tests (ANOVA and t-test)
* Design of experiments (DOE)

Many of our clients simply want an Excel spreadsheet of data with basic statistics to facilitate review meetings. We can accommodate all requests using our sophisticated LIMS system.

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