PHARMA

The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.

DGFT issued this mandate as a step towards implementing a traceability system to address counterfeit and ineffective product recall challenges, which affects the entire healthcare supply chain, from manufacturers all the way to patients, wholesalers, distributors, exporters and healthcare providers. Adopting globally harmonized standards for product identification and data exchange, is a critical step in addressing these issues.

The traceability solution implemented by the DGFT requires the use of product serialization at the secondary level packaging. Serialization enables to build a comprehensive system to track and trace the movement of drugs through the entire supply chain. By identifying every product with a globally unique product number (Global Trade Item Number [GTIN]), and by capturing information on its expiry date, batch/lot number, and unique serial number (where applicable) allows the product’s lifecycle to be tracked from production to distribution across borders, all the way to its dispensation to patients at the drugstore or hospital.

In addition to the coding and marking guidelines of products outlined in the specifications, Manufacturers/Brand Owners/Responsible Entities/Exporters/Merchant Exporters will submit additional information to a central track and trace portal. Manufactures need to maintain records of serial numbers assigned to drugs and pharmaceuticals exported for a minimum period of six months after their expiry date.

DGFT NORMS

- Primary Level packaging:

Incorporation of 2D barcodes, unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Primary pack.

- Secondary Level packaging

Incorporation of barcodes (1D or 2 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Secondary pack. Tertiary Level packaging

Incorporation of barcodes (1 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Tertiary pack (shipper/carton).

SOLUTION

Being associated with some of the biggest pharmaceutical manufacturers, our team at SUNDARAM TECHNOLOGIES develops system for Barcode printing, Barcode scanning, OCR, monitoring, quality control, logistics and Track & Trace requirement and also solution with 21 CFR complaints.

- DGFT Solution

- DAVA Portal compliances

- Our solution is 21 CFR compliant

- DQ/IQ/OQ/PQ & SOPs documentation

- FG Stores Automation

- Dispensing Automation

- WIP Automation

- Raw Material to Finished Goods Automation

- RM Quality Process Automation

- RM/PM Dispensing Automation

- Weighing Scale Automation – (Checkweigher)

- FIFO- First In First Out

- WIP Tracking

- Yield capturing at every stage of production

- RM Stores Automation

Online Maintenance

We have a dedicated team which provides online support to the clients. Maintenance can be done online, this way the production will not be delay