PHARMA & HEALTHCARE
Comprehensive Support for GMP CFR 21 Validation
The pharmaceutical industry is one of the most regulated industries and has stringent quality standards. The safety and integrity of goods passing through the supply chain is of paramount importance. In addition to the rigors of maintaining continuous Food and Drug Administration (FDA) Good Manufacturing Practice (GMP) validation across all operations at all time, new federal and state standards are emerging for tracking & tracing of shipment pedigrees through the supply chain - further affecting documentation and electronic records. On top of these regulations, unique business processes associated with the varying pharmaceutical channels like scheduled narcotics, biotechnology products, trade products, consumer products and samples & literature present challenges to maintain operational efficiency across the supply chain.
eBizNET understands these challenges and provides support to many of the world's largest pharmaceutical companies. With decades of personnel experience, we truly understand the processes involved in establishing and maintaining full compliance with the FDA GMP guidelines for the supply chain. In fact, our team has led numerous validation processes over the years and is frequently called upon by leading pharmaceutical manufacturers to provide assistance.
Unique Value to Pharma & Healthcare:
- True batch/lot control
- Expiration date tracking and alerts
- Supports FEFO, FIFO, and LIFO fulfillment strategies
- Stringent auditing and accountability methods (compliant GMP electronic records & signatures)
- Returns and claims processing
- Interfaces to lot quality management systems
- Recall management
Our extensive hands-on GMP leadership expertise and staff experience magnifies this unique value. Whether you are deploying a new site or wish to gain support during an on-going GMP audit, eBizNET stands ready with a highly qualified team to support your unique needs.