Resolve out-of-specification results before disposition

Bring raw data, method version, instrument status, sample history and related lots to the OOS investigation. QC and QA judge laboratory versus process causes without treating a retest as an automatic pass.

A request needs specialist review, financial concurrence or delegated approval.

People in the process

QQuality Control & AnalyticalProcess Owner
QQuality AssuranceParticipating Team
MManufacturingParticipating Team

Records it works with

Request, scope and proposed decision
Applicable policy and approval authority
Supporting technical, commercial and control records

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 Control & Analytical

Carry method transfers through receiving-lab readiness

Connect approved method, validation package, instruments, reference standards and transfer acceptance results. QC determines whether the receiving laboratory can support release testing on schedule.

Quality Control & Analytical

Assess stability excursions against registered shelf life

Link stability results, storage excursions, trend limits and market-approved shelf-life claims. QC and QA determine whether an investigation or regulatory change is needed before the next market supply.

Regulatory Affairs

Scope a product change across registered markets

Map proposed site, process, formula or specification changes to product dossiers, approved manufacturers and target markets. Regulatory affairs determines each filing route and implementation gate with QA before commercial rollout.

QMR

Explore all Pharma processes.

Order for the work. Room for the people.