GDP

Good Distribution Practice Compliance has become a prime requirement for the storage, transportation and handling of allied goods in the wake of recent regulations and guidelines.

PharmSol has been a front runner in offering guidance to the industry in GDP space and has once again developed an innovative business model. The solution provided by PharmSol helps every member industry of the supply chain (including manufacturers, cargo handlers, carriers, ports, airports etc.) in attaining and maintaining a level of GDP Compliance.

PharmSol’s 10 auditors have been certified as Independent Validators for CEIV Pharma and Temperature-Controlled Cargo Operations by the IATA

Compliance Assessment

As the first step, PharmSol carries out GAP Analysis Audits of the entire supply chain system commensurate with the EU GDP Guideline 2013/C 343/01 and generates comprehensive GAP Analysis Audit Reports, which become a starting point towards attaining GDP Compliance.

Capability Enhancement

Having assessed the Gaps, Team PharmSol then offers its expert assistance in bridging the Gaps and developing a robust GDP Compliance mechanism for each client.

Certification

With the compliance level attained by each Client, PharmSol then assists them in obtaining certification from an authority. At this point in time, there is limited capacity available with the regulatory authorities towards GDP Certification, however the authorities are addressing this need on a high priority. In parallel, PharmSol is also pursuing a collaboration with IATA in offering the CEIV (Centre for Excellence of Independent Validators) Certification Scheme to all its clients.

GDPnet® Membership

PharmSol is currently designing a proprietary portal which will list all GDP Certified Companies. Through this portal, companies will have an opportunity to exhibit their capabilities as well as collaborate with members across geographies. Each client of PharmSol will be offered membership to GDPnet®.

GDPvigilance®

As part of GDP Service offering, PharmSol is currently formulating an online system which will enable logging real time data of the entire journey of each pharmaceutical cargo. The cargo will be monitored by PharmSol personnel as well as automated systems. Each member industry using this system will be able to view the journey and any deviations on a real time basis. At the end of the journey, a comprehensive deviation report will be available to the Qualified Person (QP) or Responsible Person (RP) for Batch Release of the product. This report will enable the QP or RP to make an informed decision on releasing the product.

Support for CEIV Pharma Certification

• PharmSol provides assistance in seeking CEIV Pharma Certification to Pharma shippers and
   cargo handling companies
• PharmSol provides assistance in designing and implementation of QMS
• PharmSol can outsource support for day-to-day management of Quality Affairs

Good Distribution Practice Compliance has become a prime requirement for the storage, transportation and handling of allied goods in the wake of recent regulations and guidelines.

PharmSol has been a front runner in offering guidance to the industry in GDP space and has once again developed an innovative business model. The solution provided by PharmSol helps every member industry of the supply chain (including manufacturers, cargo handlers, carriers, ports, airports etc.) in attaining and maintaining a level of GDP Compliance.

PharmSol’s 10 auditors have been certified as Independent Validators for CEIV Pharma and Temperature-Controlled Cargo Operations by the IATA

Compliance Assessment

As the first step, PharmSol carries out GAP Analysis Audits of the entire supply chain system commensurate with the EU GDP Guideline 2013/C 343/01 and generates comprehensive GAP Analysis Audit Reports, which become a starting point towards attaining GDP Compliance.

Capability Enhancement

Having assessed the Gaps, Team PharmSol then offers its expert assistance in bridging the Gaps and developing a robust GDP Compliance mechanism for each client.

Certification

With the compliance level attained by each Client, PharmSol then assists them in obtaining certification from an authority. At this point in time, there is limited capacity available with the regulatory authorities towards GDP Certification, however the authorities are addressing this need on a high priority. In parallel, PharmSol is also pursuing a collaboration with IATA in offering the CEIV (Centre for Excellence of Independent Validators) Certification Scheme to all its clients.

GDPnet® Membership

PharmSol is currently designing a proprietary portal which will list all GDP Certified Companies. Through this portal, companies will have an opportunity to exhibit their capabilities as well as collaborate with members across geographies. Each client of PharmSol will be offered membership to GDPnet®.

GDPvigilance®

As part of GDP Service offering, PharmSol is currently formulating an online system which will enable logging real time data of the entire journey of each pharmaceutical cargo. The cargo will be monitored by PharmSol personnel as well as automated systems. Each member industry using this system will be able to view the journey and any deviations on a real time basis. At the end of the journey, a comprehensive deviation report will be available to the Qualified Person (QP) or Responsible Person (RP) for Batch Release of the product. This report will enable the QP or RP to make an informed decision on releasing the product.

Support for CEIV Pharma Certification

• PharmSol provides assistance in seeking CEIV Pharma Certification to Pharma shippers and
   cargo handling companies
• PharmSol provides assistance in designing and implementation of QMS
• PharmSol can outsource support for day-to-day management of Quality Affairs

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