Q11 sets out how manufacturing principles detailed in Q8, 9 and 10 apply to active pharmaceutical ingredient (API) production and clarifies the information drug companies must include in common technical documents (CTDs).
The guideline was adopted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in 2012.
But despite being in place for five years, industry still needs clarification on how best to meet the standards set out in Q11 according to the International Council for Harmonisation (ICH), which announced the launch of a draft Q&A document this month.
The organisation said: “Following on from the adoption of the 2012 guideline on development and manufacturing of drug substances, a question and answer document has been developed to clarify a number of implementation issues, particularly focusing on chemical entity drug substances."
“The draft document will now be released for stakeholder consultation.” The Q&A document is available here.
Anvisa admitted
The organisation also announced it has admitted Brazilian regulator ANVISA and the South Korean Ministry of Food and Drug Safety as its newest members.
The agencies were admitted to the International Council for Harmonisation (ICH) at a meeting in Osaka, Japan where regulatory agencies from Cuba (CECMED), Kazakhstan and South Africa were granted observer status.
Industry groups Biotechnology Innovation Organization (BIO) and the European Chemical Industry Council’s Active Pharmaceutical Ingredients Committee (APIC) were also granted observer status.