“We meet the most stringent requirements”
Sylvie Ponlot: With what regulatory requirements must TFX comply today?
Dominique Saint Ellier – QA/RA Director: These requirements are grouped in a guideline published by the EMEA (European Medecines Evaluation Agency) entitled ICH (International Conference Harmonization), which sums up the body of information which a client has to submit in a marketing authorization (AMM) file. The section dealing with primary plastic packaging for drugs compels Technoflex to provide a full description of the bag and its material: extractible studies, leachables and migrations (interaction analyses between container and content). These studies have to be conducted with the end product, prior to stability tests.
SP: What is TFX’s interest in meeting these requirements?
DSE: The stake here is to demonstrate the inertia of the Inerta® material, when in contact when the solution. To anticipate and satisfy our clients’ expectations, we conducted four complementary extractible studies, which cover all aspects of the contact between Inerta® and different solutions: WFI water, ethanol, acid (pH<2) and alkaline (pH> 11) solutions. Hence, our clients are provided with the basic data for their own stability tests, which should enable them to submit their file more quickly.
SP: How are these requirements going to evolve?
DSE: Two factors will drive their evolution: current events, which authorities take into account, and the Reach Regulation, which was implemented on June 1st, 2007. This European legislation compels industries to monitor the rates of chemicals used in manufactured and delivered products, but also their impact on man and the environment.
SP: What is TFX’s positioning regarding these constraints?
DSE: Our constant regulation watch enables us to monitor what is going on in the market, especially from a regulatory point of view. Hence, we are able to identify and assess these evolutions in order to anticipate their integration in our future products.
SP: TFX is currently renewing a certification. Can you tell us more about it?
DSE: We are renewing the ISO 1537 standard. This standard for manufacturers of drugs’ primary packaging integrates all GMPs (Good Manufacturing Practices) to be respected.