Global Pharma QA is a Limited Company (Ltd.), based in the United Kingdom, established and directed by Orit Galperin, M.Sc and Certified Quality Engineer (CQE).
Provides independent consultancy and auditing worldwide in the area of GLP/GCLP.
Prepares companies for GLP/GCLP/ ISO15189 accreditations and regulatory inspections.
Consults non-regulated companies and university laboratories for quality improvements.
Core services include Assessment of Compliance with applicable sections of the following directives:
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GLP with OECD GLP or/and FDA 21CFR part 58, for Good Laboratory Practice for Nonclinical Laboratory Studies and part 11 for Electronic Records; Electronic Signatures.
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GCLP in central and reference laboratories following the EMA/RQA/WHO and GDPR.
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Country local GLPs as CFDA GLP (Chinese GLP), Brazilian GLP etc.
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Wide experience auditing and consulting Universities and Research Centers for Good Research Practice.
We inspect and provide GCLP Laboratories Compliance Certification - valid for 2 years
Additional GLP/GCLP needs will be assessed per client request.