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.

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

People in the process

RRegulatory AffairsProcess Owner
QQuality AssuranceParticipating Team
MManufacturingParticipating Team
RR&DParticipating 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.

Regulatory Affairs

Reconcile approved artwork with every market version

Link label text, pack size, registration conditions and artwork proofs to the countries and batches concerned. Regulatory and QA approve cutover and stock disposition before packaging changes.

QPC

Regulatory Affairs

Answer authority queries from controlled source data

Collect the exact dossier version, study/report references and manufacturing changes behind an authority question. Regulatory authors a consistent response with technical owners and records the submission and commitments.

RQM

Regulatory Affairs

Check export permissions against product and destination

Join the product approval status, destination requirements, requested certificates and shipment plan. Regulatory determines whether a specific export permission or certificate is needed before operations books dispatch.

Explore all Pharma processes.

Order for the work. Room for the people.