GUIDANCE
Quality system assessment
A consultant can review procedures, records and processes to identify gaps against applicable GMP expectations and the company's operating model.
LH QUALITY CONSULTING RESOURCE
What Does a GMP Quality Consultant Do?
A GMP quality consultant helps regulated organizations strengthen the systems and practices that protect product quality and patient safety. The work can range from senior, hands-on Quality expertise to hands-on remediation.
GUIDANCE
Inspection readiness
Consultants can conduct readiness assessments, mock inspections and documentation reviews before regulators, customers or partners arrive.
GUIDANCE
Remediation and CAPA
When findings or recurring problems exist, an experienced consultant can help prioritize root causes, corrective actions, effectiveness checks and sustainable process improvements.
GUIDANCE
Manufacturing and CMC quality
GMP consulting may include manufacturing oversight, validation, technology transfer, batch disposition, quality agreements and lifecycle quality management.
GUIDANCE
Supplier and CDMO oversight
For outsourced operations, supplier qualification, audits, risk assessment and ongoing performance oversight are essential parts of a practical GMP program.
GUIDANCE
When to bring in outside expertise
External support is especially useful during rapid growth, remediation, leadership transitions, new manufacturing relationships, pre-inspection preparation or periods when internal QA capacity is stretched.
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