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Quality and Technical Support
Impeccable Standards. Absolute Control.
Quality is our focus. It is the bedrock of our entire operation
and underpins every product and process that we carry out.
From high-end quality control, regulation, testing, analysis and validation, our systems and procedures are continually scrutinised to ensure we operate and deliver the highest possible quality standards.
All our operations and equipment are controlled by Standard
Operating Procedures (SOPs), which are regularly reviewed,
and all staff are fully GMP trained.
Accreditations
Our manufacturing and warehousing operations are covered
by an impressive range of quality accreditations:
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MHRA pharmaceutical licence - The Medicines and Healthcare Regulatory Authority
www.mhra.gov.uk |
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FDA approved - US Food and Drug Association
www.fda.gov |
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ISO 9001:2000, ISO 13485:2003 |
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Manufacturer of Class 1 Medical Devices |
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Investors in People |
Microbiological Testing
Our in-house facility undertakes all forms of rigorous
microbiological testing as well as routine monitoring of raw
materials and finished products, TVC testing, and water and
environmental testing.
We also conduct BP challenge-testing to BP/USP standards
and MIC studies, particularly for product development - and
carry out regular people-challenge testing to ensure we are
operating to the highest standards of hygiene and cleanliness.
Analytical Support and Testing
Highly qualified scientists perform routine testing and analysis
of raw materials and finished products to ensure strict
compliance with product licenses.
Analytical support and testing services include:
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Full assay testing |
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Pharmacopoeia testing - BP, EP and USP |
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Method development and validation |
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Release testing |
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Full stability testing to ICH standards and requirements |
Our equipment includes:
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HPLCs |
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GCs including one with headspace |
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Auto Titrator |
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UV and IR spectrometers |
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Stability chambers |
Quality Assurance and Regulatory Assurance
Our Quality Assurance group assures full process and product
compliance with GMP (Good Manufacturing Practice)
requirements, implementation of quality systems and
appropriate employee training.
The department includes Qualified Persons (QPs) with
responsibility for the release of finished products, an audit
function and validation services.
The group also provides specialist regulation and legislation
consultancy services for both the UK and export markets,
including liaising with national and international regulatory
authorities, pre-market submissions and product registration
and licensing.
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