Industry has until November 9 to comment on the proposed adoption of 15 European Medicines Agency (EMA) guidance documents by the Australian Therapeutic Goods Administration (TGA).
Several documents cover elements of good manufacturing practices (GMPs). Some of the guidelines, such as the residual solvents document, have been in force in Europe for years, but others are more recent.
The TGA has proposed adopting EMA guidelines on live recombinant viral vectored vaccines that came into effect at the start of 2011. Clinical and quality aspects of the vaccines are discussed in the guidance.
“Substances such as diluents or stabilisers or any other excipient added during preparation of the final bulk vaccine should have been shown not to impair the efficacy and safety of the vaccine in the concentrations employed”, the guidance states.
Other recently drafted EMA documents on the TGA’s list include a question and answer paper on the limits of genotoxic impurities. In the document the EMA clarifies 2006 guidelines on genotoxic impurity limits for active pharmaceutical ingredients (APIs).
“If a manufacturing procedure for API remains essentially unchanged a re-evaluation with respect to the presence of potentially genotoxic impurities is generally not needed. However, new knowledge may indicate a previously unknown cause for concern”, the guidance states.
Guidelines for residual solvents, implemented by the EMA in 2003, are also on the TGA’s list. The guidance recommends acceptable levels of residual solvents through a risk assessment process.
“Since there is no therapeutic benefit from residual solvents, all residual solvents should be removed to the extent possible to meet product specifications, good manufacturing practices, or other quality-based requirements”, the guidance states.