Decide complaint impact beyond the first batch

Trace a reported defect through batch genealogy, other markets, distribution and prior complaints. QA leads the technical risk assessment and routes recall or field decisions to authorised specialists.

A notice, complaint, missed commitment or disputed amount opens a case.

People in the process

QQuality AssuranceProcess Owner
RRegulatory AffairsParticipating Team
PPharmacovigilanceParticipating Team
DDistributionParticipating Team

Records it works with

Relevant agreement, policy or governing record
Transaction, performance and payment history
Notices, communications and supporting evidence

The process is a starting point.The standards are yours.

Configure by product, authorisation and destination market. Regulatory Affairs and authorised quality personnel retain product-change, submission and batch-release decisions. Safety reporting and UCPMP requirements use the applicable reviewed scope.

Keep the work connected.

Quality Assurance

Hold batch disposition until exceptions are resolved

Link batch record, QC results, deviations, rework, environmental monitoring and change history. Authorised QA reviews the product-specific impact and decides release, rejection or further investigation.

Quality Assurance

Verify CAPA effectiveness against recurrence evidence

Connect root cause, actions, training, validation and subsequent batches or complaints. QA tests whether the issue actually recurred before approving closure or extending controls.

MEQ

Quality Assurance

Review recurring quality signals across product lots

Assemble batch and analytical trends, deviations, complaints, returns and stability data for the formal product quality review. QA reconciles missing inputs and cross-functional conclusions before approving process or supplier actions.

Explore all Pharma processes.

Order for the work. Room for the people.