Pharmaceutical Quality Assurance (QA)
Biotec’s commitment to pharmaceutical quality assurance and attaining the highest quality standards ensures that patient safety and customer service is never compromised through a lack of manufacturing control or service at Biotec.
Biotec’s new, purpose built facility, modern quality assurance management system and highly experienced team all combine in ensuring the highest quality levels are always achieved.
Biotec operate in compliance with the following pharmaceutical quality assurance standards and guidelines:
- EC Directives; 2001/20/EC Clinical Trials Directive, 2001/83/EC Medicinal Products for Human Use Directive, 2003/94/EC Good Manufacturing Practice (GMP) Directive.
- EC GMP guidelines; EudraLex Volume 4.
- ISO9001:2008 Quality Management Systems standard.
Biotec is routinely audited by the Medicine and Healthcare Products Regulatory Agency (MHRA) to ensure compliance with relevant EC GMP guidelines. Biotec hold the following licences (issued by the MHRA):
- Manufacturer Investigational Medicinal Products Licence MIA(IMP)/19819
- Manufacturer’s / Importer’s Licence MIA/19819
- Manufacturer Specials Licence MS/19819
- Full Wholesale Dealer Licence WL/19819
- Home Office Controlled Drugs Licence (issued by the Home Office)
Should you require any further information regarding our pharmaceutical quality assurance department or systems please contact us
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Registered Office: Biotec Services International Limited, Biotec House, Central Park, Western Avenue, Bridgend Industrial Estate, Bridgend CF31 3RT UK
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