The course “CTD module 3 – Quality (EU). Active Pharmaceutical Ingredient (API) / Drug Substance in medicinal products for Human use” is of the overview nature and introduces to the big subject of drug substance quality in the registration dossier of medicinal product in the EEA. The presentation may be very useful for those who start working on the preparation of registration dossiers in terms of the quality of an active substance for the European market or as manufacturers of active substances intend to start cooperation with marketing authorization holders operating on the European market. The course can also be addressed to employees working in regulatory, quality control, development research or production, as well as project managers.
As part of the introduction, it is discussed what the Common Technical Document (CTD) format is, when and where it is binding, what is e-submission and how the main structure of the CTD format look like. Also, the previous format of the NtA documentation and how to reformat to CTD is discussed. Thanks to this, the course participant can understand what is the role and purpose of using CTD format and what are the related obligations.
The exact structure of the active substance quality module is then discussed. Section by section of the CTD, the trainee will learn what information is included in the subsequent sections of the module. It is crucial to know where the module on the quality of the active substance ends and where the medicinal product begins. After the training, the course participant will have no doubts how to segregate the information concerning the active substance and the medicinal product. Conversely, the course will answer the question of where the active substance quality module starts and facilitate selection of the starting material. In these units, the trainee will also learn what are obligations in the field of GMP and related documents attached to the application form.
The next part of the training is a discussion of the methods of submitting documentation on the quality of an active substance in the EEA, i.e. the ASMF, CEP procedure or full dossier submission. The course participant will learn what are the advantages and disadvantages of individual procedures, which procedure to choose depending on the situation and what are the obligations, who and what documents should be prepared and where to send. In this part of the course, the trainee will learn how the type of procedure can affect the documentation from the manufacturer of the active substance, but also the documentation of the active substance from the manufacturer of the medicinal product.
Another issue that may affect the quality dossier of an active substance is whether the active substance is new and is described in a pharmacopoeia. The training will provide detailed knowledge in this area.
At the end, all current guidelines necessary for the correct preparation of individual sections of the module are listed. Almost 70 items of guidelines, questions and answers, reflection papers and websites are listed section by section. As a result, this training allows you to significantly save time in searching for the necessary reference documents, accelerate learning and reduce the risk of omitting important issues in the documentation.
