|
At BioReliance, our high profile and highly experienced
staff work to assure that the highest standards are maintained throughout
your project. The establishment and effective operation within a
testing facility of a program of Quality Assurance (QA) is a regulatory
requirement of GLP/GMP and is one of the principal means of assuring
that testing is conducted in accordance with regulatory requirements.
Additionally, the quality systems team is responsible for assuring
conformance with cGMP in our Manufacturing operations.
BioReliance's Quality Systems is responsible
for assuring compliance with worldwide GLP regulations (e.g. OECD,
FDA, EPA, EU) and applicable GMP regulations (e.g. FDA, EU, MHRA
‘Orange Guide’).
At BioReliance you can be assured of the highest quality of pro-active services:
- On-Going laboratory inspection program
- Audit of study data and final reports
- Batch approval for material produced by manufacturing group
- Document control
- Review of critical support documentation (SOPs, protocols, batch records, specifications)
- Archiving
- Host client and regulatory audits
- Perform environmental monitoring
- Assure quality of critical raw materials
- Perform inspections of suppliers and subcontractors
- Quality improvement and tracking / trending of quality key indicators
|  |
