Compliance
Our team work diligently to ensure ongoing compliance with all relevant regulations and standards to ensure our products and services are at the forefront of each industry sector’s evolving regulatory requirements.
Compliance
Quality Assurance
Quality underpins every part of E&O’s manufacturing and service operations. All processes are designed and controlled to meet the required standards across all the microbiological culture media industry sectors.
E&O Laboratories Ltd is certified to ISO 9001:2015 & BS EN ISO 13485:2016 for “The development, manufacture and supply of microbiological prepared culture media, dehydrated culture media, blood products, microbiological supplements/reagents and microbiological analytical services”
The Quality management system is designed and written to ensure accuracy and traceability throughout the business.
All manufactured Culture Media & raw material testing is subcontracted to Quality Control Department for quality control.
Test methods are accredited by UKAS in compliance with BS EN ISO/IEC 17025:2017. Methodology is based on ISO 11133:2014.
E&O Laboratories Ltd’s farm division holds a Home Office Project License for the Animals (Scientific Procedures) Act 1986 to routinely harvest & process donor animal blood products.
All Animal technicians hold personal licenses and two farms are licensed designated areas.
E&O laboratories Ltd’s clinical products are registered within the EU and UK in compliance with Regulation (EU) 2017/746 of the European Union and UK Medical Device Regulations 2002(UK MDR 2002), as amended.
Pharmaceutical culture media manufacture comply with the Harmonized MTL methods in the US/EU/JP Pharmacopoeias – International Standards and ISO criteria.
E&O Laboratories Management System incorporates the relevant criteria of Good Manufacturing Practice (cGMP) and Good Laboratory Practice (cGLP) to ensure products are consistently manufactured and controlled to defined quality.
Quality Assurance
Quality underpins every part of E&O’s manufacturing and service operations.
All processes are designed and controlled to meet the required standards across all the microbiological culture media industry sectors.
E&O Laboratories Ltd is certified to ISO 9001:2015 & BS EN ISO 13485:2016 for “The development, manufacture and supply of microbiological prepared culture media, dehydrated culture media, blood products, microbiological supplements/reagents and microbiological analytical services”
The Quality management system is designed and written to ensure accuracy and traceability throughout the business.
All manufactured Culture Media & raw material testing is subcontracted to Quality Control Department for quality control.
Test methods are accredited by UKAS in compliance with BS EN ISO/IEC 17025:2017. Methodology is based on ISO 11133:2014.
E&O Laboratories Ltd’s farm division holds a Home Office Project License for the Animals (Scientific Procedures) Act 1986 to routinely harvest & process donor animal blood products.
All Animal technicians hold personal licenses and two farms are licensed designated areas.
E&O laboratories Ltd’s clinical products are registered within the EU and UK in compliance with Regulation (EU) 2017/746 of the European Union and UK Medical Device Regulations 2002(UK MDR 2002), as amended.
Pharmaceutical culture media manufacture comply with the Harmonized MTL methods in the US/EU/JP Pharmacopoeias – International Standards and ISO criteria.
E&O Laboratories Management System incorporates the relevant criteria of Good Manufacturing Practice (cGMP) and Good Laboratory Practice (cGLP) to ensure products are consistently manufactured and controlled to defined quality.
Quality Control & Certification
Quality Control Department carries out quality control testing on the manufactured ready-to-use microbiological culture media, donor animal blood & sera, antibiotic supplements/reagents, and incoming bulk raw materials.
Certification is available online for all production batch manufacture following the completion of the QC protocol. Once all specifications are met, the batch is formally released for stock.
Quality Control Department is responsible for the reporting of all the results from the rigorous testing and monitoring regime of E&O Laboratories controlled environment areas regarding air supply, DI water and general cGMP/cGLP hygiene for the manufacturing areas in their facilities at Burnhouse and Westfield.
E&O Laboratories Ltd's technical team are continually striving to improve product performance through selective raw material sourcing, sensitive & accurate media sterilisation, innovative packaging/storage solutions and continual ongoing shelf-life analysis.
Quality Control & Certification
Quality Control Department carries out quality control testing on the manufactured ready-to-use microbiological culture media, donor animal blood & sera, antibiotic supplements/reagents, and incoming bulk raw materials.
Certification is available online for all production batch manufacture following the completion of the QC protocol. Once all specifications are met, the batch is formally released for stock.
Quality Control Department is responsible for reporting all results from the rigorous testing and monitoring regime of E&O Laboratories controlled environment areas regarding air supply, DI water and general cGMP/cGLP hygiene for the manufacturing areas at Burnhouse and Westfield.
E&O Laboratories Ltd's technical team are continually striving to improve product performance through selective raw material sourcing, sensitive & accurate media sterilisation, innovative packaging/storage solutions and continual ongoing shelf-life analysis.