Microbiological standards for medicines in the Australia New Zealand Therapeutic Products Authority (ANZTPA)
Consultation
27 July 2006
Note: This consultation closed on 15 September 2006.
Consultation paper
Background
The Joint Agency Establishment Group invites your comments on the consultation paper on microbiological standards for medicines under the proposed Australia New Zealand Therapeutic Products Authority. The closing date for submissions is 15 September 2006.
Australia and New Zealand both apply microbiological standards for medicines. Medicines supplied in Australia are generally expected to comply with the preservative efficacy requirements of the British Pharmacopoeia (BP) and the microbial attributes specified in the TGA Laboratories' guidelines for assessing the results of microbiological tests on non-sterile pharmaceuticals for human use. The parameters used to evaluate preservative efficacy and microbial attributes for medicines regulated by Medsafe are described in the NZ Regulatory Guidelines & Codes for Medicines, Volume 1.
The Joint Interim Expert Advisory Committee on Standards (JIEACS, the Committee) was established to advise on the setting of harmonised standards to apply to therapeutic products in both Australia and New Zealand upon the commencement of the Australia New Zealand Therapeutic Products Authority (ANZTPA). The Committee noted areas in which the European Pharmacopoeia (Ph Eur), the British Pharmacopoeia (BP) and the United States Pharmacopoeia – National Formulary (USP-NF) had achieved harmonised texts. For example, the Test for Sterility and the Bacterial Endotoxin Test are essentially the same.
The Committee also noted inconsistencies and/or conflicts in requirements regarding preservative efficacy and microbial attributes for non-sterile medicines between the three pharmacopoeias. In the view of the Committee, such inconsistencies and/or conflicts would not allow the same level of assurance to the ANZTPA of product quality and safety for products manufactured to comply with the requirements of the different pharmacopoeias.
The purpose of this consultation paper is to seek stakeholder input into the microbiological standards that should apply to medicines in Australia and New Zealand when the ANZTPA commences operation. The principal issues to be considered are how the preservative efficacy of sterile and non-sterile multidose medicines, and the microbial attributes of non-sterile medicines, can be assured to an appropriate level.
The consultation paper has been reviewed by the Pharmacopoeial Standards Subcommittee of the JIEACS, which has requested that it be released for broad stakeholder consultation in Australia and New Zealand.
URL: http://www.anztpa.org/consult/microbiological.htm
PDF: http://www.anztpa.org/consult/microbiological.pdf