We can perform work to the following standards in order to meet the requirements of clients from different industry sectors:
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Good Manufacturing Practice (GMP) as it relates to contract analytical services
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BS EN ISO/IEC 17025 (UKAS Accreditation of Testing Services)
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Good Clinical Practice (GCP)
Related Documents
Good Manufacturing Practice (GMP)
We perform pharmaceutical services (pharmacopoeial testing, release testing and stability testing) following our GMP Quality System.
We have been issued with Certificates of GMP Compliance for products for human use and veterinary products stating that RSSL comply with the principles and guidelines of Good Manufacturing Practices as laid down in Directives 2003/94/EC and 91/412/EEC respectively, by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). We have also been inspected by the United States Food and Drug Administration against current Good Manufacturing Practice (cGMP) and classified as an acceptable contract testing laboratory.
Please find PDF’s of our approvals from the MHRA and the FDA. If you have any questions regarding these, please contact our Quality Assurance Unit (QAU) on 0118 918 4159 or email R.Reading.QEHS@rssl.com
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Good Clinical Practice (GCP)
Where required, consumer research studies can be conducted in accordance with Good Clinical Practice as interpreted in the ICH Harmonised Tripartite Guideline. To ensure compliance with this, studies are subject to audit by our QAU. The Declaration of Helsinki and its amendments are respected at all times. We obtain written approval for these studies from an appropriately constituted Ethics Committee. The Committee requires a full written protocol, containing a detailed description of the research methodology along with full details of the formulation of each product, relevant safety data, proposed information sheets and informed consent forms along with Case Report Forms which are to be used.
UKAS Testing
Our laboratories perform testing that is accredited by United Kingdom Accreditation Service (UKAS) as being compliant with BS EN ISO/IEC 17025. It is our policy to accredit all testing that is carried out routinely by the laboratories. However, since the Quality System operates throughout all laboratories and many of the procedures are common for work performed, even work that is not accredited, benefits significantly from our UKAS accreditation.
We are registered as Accredited Testing Laboratory No 1216.
Tests that are accredited by UKAS are listed in our Schedule of Accreditation.