The re-labelling operation may be performed by authorized personnel at a hospital, health centre or clinic that meet the requirements of Article 61 of the CTR.Ĭhapter X Labelling of the CTR contains the following information on what shall appear on the outer packaging ( secondary packaging) and on the immediate packaging ( primary packaging): Any discrepancies observed during reconciliation should be investigated and accounted for before release.
A line clearance at the start and end of activity should be carried out and label reconciliation performed. To avoid mistakes the additional labelling activity should be carried out in an area which is partitioned or separated from other activities. This additional labelling should be properly documented in the batch records. The re-labelling operation should be performed by appropriately trained staff in accordance with GMP principles and specific standard operating procedures (SOPs) and should be checked by a second person. It may be superimposed on the old expiry date, but for quality control reasons, not on the original batch number.
Imops system trial#
This additional label should state the new expiry date and repeat the batch number and clinical trial reference number. If it becomes necessary to change the expiry date, an additional label should be affixed to the IMP.The labelling operation should be performed at an authorized manufacturing site that complies with the requirements of Article 61 of the CTR. A list of information which shall appear on the labelling is set out in Annex VI ( Labelling of IMPs and auxiliary medicinal products) to the CTR. Labelling of IMPs shall comply with the requirements of Chapter X Labelling of the CTR.Labelling of the Detailed Commission Guideline states: by using a centralized electronic randomization system / centralized information system, is only allowed in specific cases for specific parts of information (for example particulars on the main contact like sponsor, contract research organization or investigator). According to the CTR the period of use (expiry date or re-test date as applicable), in month and year format and in a manner that avoids any ambiguity has to be provided on the primary packaging.Īdditionally, replacing of information and providing this information by other means, e.g. in cases where primary and secondary packaging are provided together or small primary packaging systems like blister packs or small units such as ampoules are used) in comparison with the previous Annex 13. For unauthorized IMPs it has been amended, for example, that " in the case of blind clinical trials the name of the substance is to appear with the name of the comparator or placebo on the packaging of both the unauthorized IMP and the comparator or placebo".įurthermore, some of the particular requirements have been amended in the CTR in regard to limited labelling of immediate packaging (i.e. This table is not provided in the Detailed Commission Guidieline and requirements and guidance for labelling have been moved from GMP to GCP as they are now part of Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR) including its Annex VI. The previous Annex 13 contained detailed requirements and guidance for IMP (investigational medicinal product) labelling together with a summary of labelling details provided in Table 1 of Annex 13. GMP Courses & Conferences on Site (in hotels)Īs previously reported the final " Detailed Commission guidelines on GMP for IMPs for human use" have been published in December 2017 in Annex 13 of the EU GMP-Guidelines.
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