Rubber Consultants started carrying out work for the Pharmaceutical industry in the early 1990s. As the laboratory already had a
   capability for nitrosamine testing (since early 1980s) this was one of the first areas of demand.

   1990 Extractables testing for a drug manufacturer.
  
   1992 Extractables testing for rubber component suppliers.

   1996 Testing drug media for various rubber residuals. Validation to ICH Guidelines.

   1996 Achieved NAMAS accreditation, now UKAS accreditation to ISO17025.

   2001 Development and validation of a set of 16 extractables and leachables methods for a major drug manufacturer. These are
            still used to test both R&D stability samples and Production samples. This expanded our capability to plastics as well as
            elastomers, and to a much broader range of target compounds.

   2004 ISO 9001 accreditation achieved site-wide.

   2005 R&D stability testing started to come under GMP control.

   2008 Our QMS expanded to encompass the Orange Guide.

   A list of QPs is available on request.

RC Pharma, Brickendonbury, Hertford, United Kingdom, SG13 8NL
T: + 44 (0)1992 554657    F: +44 (0)1992 504248
E: rcpharma@rubberconsultants.com

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Analytical Testing for the Pharmaceutical & Healthcare Industries
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