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.

A draft, counterparty revision or request to update a playbook is received.

People in the process

QQuality AssuranceProcess Owner
MManufacturingParticipating Team
QQuality ControlParticipating Team

Records it works with

Current draft and previous versions
Approved playbook and fallbacks
Negotiation history and business instructions

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

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.

Quality Assurance

Close inspection observations against proved corrections

Assign authority findings to root causes, batch scope, remediation and effectiveness evidence. QA checks the response against actual records before authorised submission and inspection follow-up.

MER

Explore all Pharma processes.

Order for the work. Room for the people.