Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Development of an adequate strategy for a global change in the primary container closure system of a parenteral herbal drug ***

Dr. Christin Selent-Stier (Abschlußjahr: 2013)

Summary

Language: English

The aim of this master thesis is the development of a suitable strategy for a global change in the primary packaging of a parenteral herbal drug in the EU (especially Germany), USA and Canada. This herbal drug is an aqueous solution for injection for subcutaneous administration at cancer.

At the moment the primary container closure system is a one-point-cut (OPC) glass ampoule. However this primary packaging shows some problems regarding the handling by the patient. In some cases the patient got percutaneous injuries after breaking the ampoules.

Therefore the production department wants to find a primary packaging, which is more appropriate compared to the current OPC-ampoules regarding patient-friendliness and the safety aspect. The task for the responsible regulatory affairs manager and the production department is to evaluate the regulatory requirements for a change of the primary packaging. The decision analysis should be used as a tool to find the best regulatory strategy on the basis of the collected data.

Following aspects should be considered:
Which kinds of other primary packaging systems are available?
Which could be an improvement of the current packaging system?
Which are a realistic time line and the costs of the proposed global change in the USA, Canada and EU (especially in Germany)?

As result of data collections following possibilities for an improvement of the current primary packaging material are evaluated in the decision analysis:

Variant 1: ampoule opener
Variant 2: prefilled syringe with glass barrel
Variant 3: prefilled syringe with plastic barrel
Variant 4: auto-injector system for prefilled syringes
Variant 5: auto-injector system for vials

Based on the evaluation of collected data and the decision analysis the auto-injector system for vials is selected as the best strategy for the improvement of the current primary packaging material „glass ampoule“. Advantages of this system are as follow:

• High innovation
• Improvement of safety aspect and patient compliance (reduction of needle phobia)
• Lower development costs for the change from the ampoule to a vial compared to the change from the ampoule to a prefilled syringe
• Competitive advantage compared to other pharmaceutical companies

This thesis summarizes the regulatory requirements for an improvement of primary packaging material and should be a supportive document for the development of the best regulatory strategy concerning the proposed change in the primary packaging material.

Pages: 90, Annexes: I (pages: 5)