GUIDANCE
Classify supplier risk
Consider the material or service, product impact, data access, manufacturing role, regulatory history and ability to affect quality.
LH QUALITY CONSULTING RESOURCE
Supplier Quality & GMP Auditing
Outsourcing does not outsource responsibility for quality. A risk-based supplier quality program helps pharmaceutical and biotech companies qualify critical suppliers, assess performance and maintain appropriate oversight.
GUIDANCE
Qualify before relying on the supplier
Qualification may include questionnaires, documentation review, audits, quality agreements and evaluation of relevant certifications or inspection history.
GUIDANCE
Audit with a purpose
A useful GMP audit should evaluate controls that matter to the sponsor, not simply produce a long checklist. Focus on systems, evidence and recurring risks.
GUIDANCE
Document findings clearly
Findings should describe the observed condition, evidence, relevant requirement or expectation and potential impact. Avoid vague observations that are difficult to remediate.
GUIDANCE
Track remediation and effectiveness
Supplier quality does not end when the audit report is issued. Track commitments, assess responses and escalate significant or recurring issues.
GUIDANCE
Maintain ongoing oversight
Use supplier performance, deviations, complaints, change notifications and audit history to determine whether the supplier's risk rating should change.
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