Clear pharmaceutical export consignments with required regulatory certificates

Check each export order against registration abroad and approval status in India, and obtain the export NOC, government laboratory certificate or CoPP it needs. Quality Assurance can release only fully certified batches, and Logistics can clear customs with a complete document set.

Starts when

Confirmation of an export purchase order or tender award for formulations or APIs.

Runs: Per consignment; weekly or daily for active exporters.

People in the process

RRegulatory AffairsProcess Owner
EExport SalesParticipating Team
QQuality ControlParticipating Team
QQuality AssuranceParticipating Team
LLogisticsParticipating Team

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

Implement NPPA ceiling price revisions across invoicing and stock

Map each NPPA ceiling price notification or annual revision to affected products, compute the new MRP and apply it to price masters, packs and channel stock. Regulatory Affairs can circulate revised price lists with proof of dissemination and answer any overcharging notice.

FCSIL

Quality Assurance

Investigate and respond to NSQ reports on drug batches

Verify a government analyst report or NSQ alert against batch records, distribution data and the retained sample, logging the date of service. Quality Assurance and Legal can decide whether to contest or recall, and reply to the drug controller with root-cause findings.

RQLS

Quality Assurance

Execute drug batch recalls and report closure to regulators

Trace every consignee of the recalled batch from dispatch records, and reconcile quantities manufactured, distributed and returned before supervised destruction or reprocessing. Quality Assurance can follow up every shortfall and give the licensing authority a closing report with root cause and corrective actions.

RSSLF

Explore all Pharma processes.

Order for the work. Room for the people.