GxP-Blog

At record speed to the patient – development of a Transport Verification Master Plan (TVMP) for a newly developed pharmaceutical product.

Chemgineering Germany was commissioned to developa Transport Verification Master Plan (TVMP) for transporting a cold-sensitive pharmaceutical product. The project included the transport of intermediate and final products as well as related documents such as a requirement specification, GMP (Good Manufacturing Practice) risk analysis, logs and reports.

Patients were waiting for the newly developed pharmaceutical product

For the global introduction of a new pharmaceutical product, Chemgineering took on the important role of developing a master plan for transport verification, including a URS (URS = User Requirement Specification) and a GMP risk analysis. In addition, the reports on the implementation and the associated reports after the implementation of the individual transport steps were created. The aim of the project, in cooperation with a number of partners and contractors, was to bring a new pharmaceutical product to patients safely via the various parties in the supply chain as fast as possible.

Safe, efficient and documented from manufacturer to patient – The Transport Verification Master Plan (TVMP)

The Transport Verification Master Plan (TVMP) described how the verification process, strategy, activities and documentation were planned and had to be implemented as part of the project. The TVMP regulated all user requirement specifications, all packaging materials and products that were used during the implementation of the verification and all tests that had to be performed during the verification. A GMP risk analysis (GMP RA) had been prepared and was taken into account in every transport verification protocol (TVP).

In the requirement specification, each item was marked with a unique number, a description of the user requirement and a criticality, which was then categorized. A modified FMEA (Failure Mode and Effect Analysis) format was used to create the GMP RA. Possible errors and risks were evaluated in terms of their severity (S), probability of occurrence (A) and detection (D). The URS and GMP RA were used to create logs with the items to be processed.

The TVMP applied to any transport route outside the plant gates that was necessary for the manufacture of the active ingredient from the first production steps to the final delivery. It began with the loaded vehicle and ended with the arrival at the destination/recipient.

Our strategy for trouble-free GMP-compliant transport

Transport routes
The transport routes must be clearly defined in the TVMP in order to ensure a smooth verification process. These include:

  • Which intermediate product
  • From which production facility to which recipient
  • What temperatures must be maintained for the pharmaceutical product

Transport temperatures
The very low temperatures to be maintained posed a challenge for the project's transports. All transports were therefore monitored with data loggers so that possible temperature fluctuations were always detected during the transports.

Deviations
If errors occurred, a deviation was created in accordance with the customer SOP and processed accordingly.

We achieved our goal with these activities

Transport Verification Protocols (TVP)
Transport verification protocols were created for all transport routes to be carried out.

Carrying out the transport
The data loggers were attached to the goods at the specified points (in accordance with the packaging specification), the transport was carried out and the data loggers were evaluated after transport.

Transport Verification Reports (TVB)
The reports described all activities and observations during the execution of the transport verification according to the TVMP and the TVP. The test results of the transport process were evaluated with regard to the transport hazards such as temperature and mechanical stress (e.g., vibration, shock, temperature) and their possible impacts on the physical integrity of the product packaging (e.g., damage to the cartons). It was demonstrated that all identified risks of the risk assessment and the necessary measures were covered during the transport verification (keyword: traceability).

GMP-compliant documentation
All required documents had to be created, approved and made available before the transport was carried out. After carrying out the transport, all documents had to be evaluated and processed in accordance with GMP.

Conclusion Transport Verification Master Plan (TVMP)

Using the procedure presented here, it was possible to verify the transport routes in compliance with GMP in the shortest possible time and to submit the documents required for the authorities in order to distribute the medicinal product safely, qualified and efficiently on the market.

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