Transition to pharmaceutical GMP compliance
In addition to the standards framework that is detailed above, and to which the Nicovape® Q system currently adheres, Liber is implementing a program of works to build a full pharmaceutical GMP supply-chain in anticipation of filing an application to register the Nicovape® Q device and range of nicotine e-liquids on the ARTG in 2024.
While pharmaceutical GMP is not a requirement for unregistered NVPs being supplied pursuant to TGO 110, Liber has made the decision to fast-track the pharmaceutical GMP compliance of our supply-chain.
To facilitate this transition, Liber is undertaking the following processes:
- A Bureau Veritas audit of our device manufacturing facility for conformance with ISO 13485 (medical devices). The facility is certified to ISO 9001 and US 21 CFR part 110 (GMP for Human Food). A fit-gap audit has been conducted to ensure the facility meets the requirements of ISO 13485;
- Engaging a UK-based Contract Manufacturing Organisation certified by the MHRA (UK medicines regulator) for compliance with pharmaceutical GMP for liquid dose manufacturing. In this regard, Liber notes that the TGA has a Mutual Recognition Agreement with the MHRA for GMP inspections.
To mitigate any safety concerns regarding the use of food-grade materials during the transition period, Liber notes the following:
- The API and excipients used to manufacture the Nicovape® liquids are produced under pharmaceutical GMP standards and comply with the respective monographs;
- The liquids have been subjected to Hazard Screening, and are within acceptable limits;
- Liber uses synthetic, molecularly defined flavour compounds in its liquids, all of which it has screened for human health hazards. None are carcinogenic, mutagenic or reproductive toxins and all are present at levels below toxicological concern; and
- Liber has conducted testing on the liquids and device-generated aerosol to ensure Harmful or Potentially Harmful Constituents (HPHCs) are absent or present below levels of toxicological concern.
Liber uses a conservative lifetime exposure assumption in all its toxicological evaluations.