Quality Assurance (QA) and Quality Control (QC) Operations have been in place for
several years to insure that products at Asymchem are prepared responsibly and in
accordance with ISO 9001 standards. With QA available in every shift, compliance
to the demands of cGMP is now in place for operations up through kilo-lab scale.
Construction of a new, cGMP pilot plant is underway and will be operation by Sept 07.
Audits by our pharmaceutical/biotech customers are welcomed and considered an
integral part of our commitment to continuous quality improvement.
QA system functions:
Raw Material Release ;
Intermediates Release ;
Batch Record Review ;
Final product Release ;
Change Control ;
Deviation/OOS investigation ;
Document Retention and archives ;
COA Review and Approval ;
Quality concerns ;
QA present in every shift, 24/7 ;
GMP compliance program-ICH Q7A.
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