The joint advice comes in the form of a Q and A document
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications. The joint advice comes in a question-and-answer document.
The document asks what the FDA and EMA expectations are regarding quality target product profile (QTPP) submissions and says a tabular format would be useful. It adds that pharma companies need to stress how medicines can be made to 'ensure the desired quality, taking into account [its] safety and efficacy…' Also, as for critical quality attribute (CQA) submissions, these should include 'acceptance limits for each CQA, and a rationale for designating these properties as a CQA'. It says they should include a discussion on how a substance and excipient CQAs 'relate to the finished product CQAs, based on prior knowledge, risk assessment and experimental data'.
Both agencies oppose the use of the term ‘key process parameters’ in filings, noting that 'different applicants use the term “key’” differently, leading to more difficult internal communication'.
Generally, it said process descriptions needed to be comprehensive and noting the various steps sequentially, along with batch sizes and equipment type. Critical steps in manufacturing needed to be highlighted, it added.
The conclusions follow a three-year pilot programme by the FDA and EMA involving a parallel assessment by these regulators of certain quality or chemistry, manufacturing and control (CMC) applications relevant to QbD, which involves statistical, analytical and risk-assessment methods to design and develop quality pharmaceuticals.