Q.I.c.1 Change in immediate packaging of the active substance
Q.I.c.3 Change in analytical procedure for the immediate packaging of the active substance
#qic1
| Q.I.c.1 Change in immediate packaging of the active substance | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| (a) Change in immediate packaging of non-liquid active substance | 1, 2, 3 | 1, 2, 3, 4 | IA |
| (b) Change in immediate packaging of sterile liquid active substance | II | ||
| (c) Change in immediate packaging of nonsterile liquid active substance | 1, 2, 4, 5 | IB | |
| (d) Deletion of one of the authorised immediate packagings of the active substance | 4 | 1 | IA |
| Conditions | |||
| 1. The proposed packaging material must be at least equivalent to the approved material in respect of its relevant properties. | |||
| 2. Relevant stability studies have been started under ICH conditions and relevant stability parameters have been assessed in at least two pilot scale or industrial scale batches and at least three months satisfactory stability data are at the disposal of the applicant at time of implementation. However, if the proposed packaging is more resistant than the existing packaging, the three months’ stability data do not yet have to be available. These studies must be finalised and the data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the shelf life/retest period (with proposed action). | |||
| 3. The active substance is not a sterile active substance or biological active substance. | |||
| 4. There should be at least one remaining packaging adequate for the storage of the active substance at the authorised conditions. | |||
| Documentation | |||
| 1. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). | |||
| 2. Appropriate data on the new packaging (e.g. comparative data on permeability e.g. for O2, CO2 moisture). Where appropriate, proof must be provided that no interaction between the content and the packaging material has no impact on the active substance quality (e.g. no migration of components of the proposed material into the content and no loss of components of the product into the pack), including confirmation that the material complies with relevant pharmacopoeia requirements or legislation of the Union on plastic material and objects in contact with foodstuffs. | |||
| 3. A declaration from the marketing authorisation holder or the ASMF holder as appropriate that the required stability studies have been started under ICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem. Assurance should also be given that the studies will be finalised and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved shelf life (with proposed action). | |||
| 4. Comparison of the current and proposed immediate packaging specifications, if applicable. | |||
| 5. The results of stability studies that have been carried out under ICH conditions, on the relevant stability parameters, on at least two pilot or industrial scale batches, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved retest period (with proposed action). | |||
#qic2
| Q.I.c.2 Change in the specification attribute and/or acceptance criteria of the immediate packaging of the active substance | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| (a) Change of specification acceptance criteria | 1, 2, 3, 4 | 1, 2 | IA |
| (b) Addition of a new specification attribute to the specification with its corresponding analytical procedure | 1, 2, 5 | 1, 2, 3, 4 | IA |
| (c) Deletion of a non-significant or obsolete specification attribute | 1, 2, 6 | 1, 2, 5 | IA |
| (d) Replacement of a specification attribute with its corresponding analytical procedure | 1, 2, 3 | IB | |
| Conditions | |||
| 1. The change is not a consequence of any commitment from previous assessments to review specification acceptance criteria (e.g. made during the procedure for the marketing authorisation application or a Type II variation procedure) unless it has been previously assessed and agreed as part of a follow-up measure. | |||
| 2. The change does not result from unexpected events arising during manufacture of the packaging material or because of stability concerns during storage of the active substance, and is not as a result of a safety or quality issue. | |||
| 3. Any change should be within the range of currently approved acceptance criteria. | |||
| 4. The analytical procedure remains the same, or changes in the analytical procedure are minor. | |||
| 5. Any new analytical procedure does not concern a novel non-standard technique or a standard technique used in a novel way. | |||
| 6. The change is not related to a revision of the control strategy with an intention to minimise testing of parameters and attributes (critical or non-critical). | |||
| Documentation | |||
| 1. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). | |||
| 2. Comparative table of current and proposed specifications. | |||
| 3. Details of any new analytical procedure and validation data, where relevant. | |||
| 4. Justification from the marketing authorisation holder or the ASMF Holder, as appropriate, of the new specification attribute and the acceptance criteria. | |||
| 5. Justification/risk assessment from the marketing authorisation holder or the ASMF Holder, as appropriate, that the specification attribute is non-significant, or obsolete. | |||
#qic3
| Q.I.c.3 Change in analytical procedure for the immediate packaging of the active substance | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| (a) Minor change to an approved analytical procedure | 1, 2, 3 | 1, 2 | IA |
| (b) Other change to an analytical procedure (including replacement or addition) | 1, 3 | 1, 2 | IA |
| (c) Deletion of an analytical procedure if an alternative procedure is already authorised | 4 | 1 | IA |
| Conditions | |||
| 1. Appropriate validation studies have been performed in accordance with the relevant guidelines and show that the updated analytical procedure is at least equivalent to the former procedure. | |||
| 2. The analytical procedure should remain the same (e.g. a change in column length or temperature, but not a different type of column or method). | |||
| 3. Any new analytical procedure does not concern a novel non-standard technique or a standard technique used in a novel way. | |||
| 4. There is still an analytical procedure registered for the specification attribute. | |||
| Documentation | |||
| 1. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format), including a description of the analytical methodology, a summary of validation data. | |||
| 2. Comparative validation results or if justified comparative analysis results showing that the current analytical procedure and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new analytical procedure. | |||
#qic4
| Q.I.c.4 Change of a secondary packaging component of the active substance (including replacement, addition or deletion), when mentioned in the dossier | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| 1, 2, 3, 4 | 1 | IA | |
| Conditions | |||
| 1. The secondary packaging does not play a functional role on the stability of the active substance, or if it does, it is not less protective than the approved one. | |||
| 2. The changed packaging component must be adequate for the storage of the active substance at the authorised conditions. | |||
| 3. The change should not be due to critical deficiencies of the former packaging component. | |||
| 4. The change is not a result of any unexpected events arising during manufacture or because of stability concerns during storage of the active substance. | |||
| Documentation | |||
| 1. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). | |||
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