Auditing

We perform full on-site assessment/audit and mock inspections of all GXP areas of Quality Assurance, Quality Control, Manufacturing, Equipment Qualification and Software and Process  Validation,  Chemistry, and microbiology laboratories in relation to the site’s GMP Compliance.  Resulting in the Reports of “readiness” or gaps in compliance and provided recommendations for any remediation requirementsWe perform full on-site assessment/audit and mock inspections of all GXP areas of Quality Assurance, Quality Control, Manufacturing, Equipment Qualification and Software and Process  Validation,  Chemistry, and microbiology laboratories in relation to the site’s GMP Compliance.  Resulting in the Reports of “readiness” or gaps in compliance and provided recommendations for any remediation requirements

GMP Auditing → - Mock inspections and SME readiness

GCP Auditing → Mock inspections and SME readiness

GLP Auditing → Mock inspections and SME readiness

Supplier Auditing → Mock inspections and SME readiness

MQSS consultants have extensive knowledge of Compliance- Mock Inspections, Facilitating responses to address FDA-483s and Warning Letters, and she has helped many companies (worldwide) to prepare for FDA inspections and participated/facilitated responses during the inspection (in front room) and managed back room as well.