Control process changes through validation and market gates

Link proposed parameters, risk assessment, qualification batches and approved instructions to product registration impact. Manufacturing schedules implementation only after QA and regulatory resolve the technical and market gates.

A proposed change affects an approved product, process, contract or operating plan.

People in the process

MManufacturing & Technical OperationsProcess Owner
QQuality AssuranceParticipating Team
RRegulatory AffairsParticipating Team
EEngineeringParticipating Team

Records it works with

Change request and current approved baseline
Affected agreements, policies and operating records
Technical, commercial and regulatory assessments

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.

Manufacturing & Technical Operations

Carry equipment qualification into the production plan

Connect installation tests, calibration, cleaning validation, deviations and training to planned product campaigns. Technical operations identifies what must be completed before equipment is used for a batch.

Manufacturing & Technical Operations

Resolve yield losses before the next campaign

Join batch genealogy, line events, rejected material and approved process limits. Manufacturing and QA decide corrective trials and stock disposition before scheduling repeat production.

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.