15 th Jun Authoring Quality Documents
Authoring Quality Documents
It’s important to think about the level of detail you are including to prevent unnecessary applications for amendments further down the line and reduce the potential for questions from the Agency. From First in Man (FIM) to manufacturing authorisation the guidance is clear, and providing superfluous information is neither beneficial nor appropriate for the assessor or applicant.
“There can be a fine line between providing enough information to adequately demonstrate the quality of the product is consistently controlled, and tying your company down to unmanageable restrictions.”
However, broad guidance dictates that information should be related to the medicinal product or active ingredient in question, and regurgitation of general elements of Good Clinical Practice, Good Manufacturing Practice or quality assurance is neither required nor advisable.
The quality requirements for a dossier for a clinical trial and those for a marketing authorisation dossier are markedly different. Bearing in mind the fact that levels of control will also differ during the individual phases of clinical trials as you build knowledge and experience is important. While some differences in the lifecycle expectations are highlighted by the EMA, due to so many contributing elements, a very detailed set of requirements to cover all scenarios is not provided by authorities.
Information to be provided for investigational medicinal products should focus on the risk aspects. At Phase 1, the start of building your quality case, overall manufacturing and product experience is limited. Stability of the product is not significantly tested and exposure is low, so quality elements such as well-defined specification limits and shelf life are not expected by assessors.
As manufacturing processes become more clearly defined and you work through Phase 2 and Phase 3, your breadth of data increases. With larger and longer exposure of patients, the expectation is that your processes and limits are refined based on this experience, and your quality documentation should reflect this. Specifications and acceptance criteria set for previous Phase 1 or Phase 2 trials should be reviewed by the applicants and adjusted as necessary to the stage of development.