Type or paste a DOI name into the text box. They provide the EEA’s harmonised position on issues that can be supply chain management multiple choice questions and answers pdf to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures.
These questions have been produced to provide clarification or additional information, and should be read in conjunction with the European Pharmacopoeia, quality guidelines and other guidance documents. References in this Annex to changes to the marketing authorisation dossier mean addition, replacement or deletion, unless specifically indicated. For the purpose of illustration and comparison, change code B. Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking.
If the applicant wishes to apply for more than one tablet strength, what level of difference in the appearance between the different tablet strengths would be required? V June 2011In the case of applications for more than one tablet strength, the different tablet strengths should be distinguishable at a level sufficient to avoid mistakes between the different strengths by the final user. In case more than one active substance produced at different manufacturing sites is mixed together at a different manufacturing site, is it possible to consider the mixing as active substance manufacture? The mixing of active substances that can exist and are produced on their own should be considered as the first step of the manufacture of the finished product. When is it necessary to perform in-use stability studies on solid oral dosage forms such as tablets and capsules in multi-dose containers? If an in-use study is required, what length is appropriate? V January 2018The length of the in-use stability studies will be dependent on the intended use of the drug product.
An in-use shelf life should only be set if necessary, i. VICH GL3 as relevant, are observed. If only one multi-dose container will be needed for the treatment, the in-use studies should cover at least the length of the treatment. The study should cover the worst case scenario in respect of the container closure system size. If more than one container is needed, one of the two bullet points below should be used for guidance.
If the treatment is of definite length and the content of one multi-dose container will not suffice, or if the treatment is continuous without a defined end, the studies should cover at least the time necessary to consume the content of two containers to accommodate a situation where the patient takes doses from two containers in parallel. The study could be designed with a less than daily opening of the container. If no relevant change is observed in the in-use study after 6 months for a product in its immediate packaging, the study does not need to be continued and no in-use shelf life should be set. A relevant change in this context is an observed change to a quality attribute that is trending toward an out of specification result. Can an open dish stability study be used to assess in-use stability?
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Storage without the protection of the immediate container is considered as a worst case scenario, and can in some instances be used to assess the need for an in-use shelf life. When is it necessary to claim an in-use shelf-life in the SPC for solid oral dosage forms such as tablets and capsules in multi-dose containers? The in-use stability studies show no relevant deterioration. The applicant proposes an in-use shelf-life of x months, as this is the time covered by the in-use stability study. A the in-use study should be performed according to Questions 2 or 3 at the applicant’s discretion.
When no relevant deterioration is observed an in-use shelf-life is not necessary. No claims should be made in the SPC and questions on the introduction of an in-use shelf-life should not be raised by the Authorities. The in-use stability studies show out of specification results after y months and support stability over x months. The SPC makes a claim for an in-use shelf-life of x months.