Q.I.e.4 Changes to a post-approval change management protocol (PACMP)
Q.I.e.5 Implementation of changes foreseen in a post-approval change management protocol (PACMP)
#qie1
| Q.I.e.1 Introduction of a new design space (method operable design range (MODR)) or extension of an approved design space for the active substance | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| (a) New design space for one or more unit operations in the manufacturing process of the active substance including the resulting in-process controls and/or analytical procedures | 1, 2, 3 | II | |
| (b) New design space for an analytical procedure for a starting material/reagent/intermediate and/or the active substance | 1, 2, 3 | IB | |
| (c) Changes to, or extension of, an approved design space for the active substance and/or an analytical procedure for a starting material/reagent/intermediate | 1, 2, 3 | IB | |
| Documentation | |||
| 1. The design space has been developed in accordance with the relevant European and international scientific guidelines. Results from product, process and analytical development studies including risk assessment and multivariate studies or process modelling, as appropriate, demonstrating where relevant that a systematic understanding of how material attributes and process parameters impact the critical quality attributes of the active substance has been achieved. | |||
| 2. Description of the design space in tabular format, and/or in the form of mathematical equation, as relevant, including the variables (material attributes and process parameters, as appropriate) with their proposed ranges and limits. | |||
| 3. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). | |||
#qie2
| Q.I.e.2 Introduction of a post-approval change management protocol (PACMP) related to the active substance | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| 1, 2, 3 | II | ||
| Documentation | |||
| 1. Detailed description for the proposed change. | |||
| 2. Post-approval change management protocol related to the active substance. | |||
| 3. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). | |||
#qie3
| Q.I.e.3 Deletion of a post-approval change management protocol (PACMP) related to the active substance | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1, 2 | IA | |
| Conditions | |||
| 1. The deletion of the post-approval change management protocol related to the active substance is not a result of unexpected events or out of specification results during the implementation of the change(s) described in the protocol and does not have any effect on the already approved information in the dossier. | |||
| Documentation | |||
| 1. Justification for the proposed deletion. | |||
| 2. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). | |||
#qie4
| Q.I.e.4 Changes to a post-approval change management protocol (PACMP) | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| (a) Major changes to a post-approval change management protocol | II | ||
| (b) Minor changes to a post-approval change management protocol that do not change the strategy defined in the protocol | 1 | IB | |
| Documentation | |||
| 1. Declaration that the changes do not change the overall strategy defined in the protocol and are not broader than the currently approved protocol. | |||
#qie5
| Q.I.e.5 Implementation of changes foreseen in a post-approval change management protocol (PACMP) | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| (a) Implementation of changes foreseen in a PACMP via Type IA notification | 1 | 1, 2, 3 | IA |
| (b) Implementation of changes foreseen in a PACMP via Type IAIN notification | 2 | 1, 2, 3, 4 | IAIN |
| (c) Implementation of changes foreseen in a PACMP via Type IB notification | 1, 2, 3, 4 | IB | |
| Conditions | |||
| 1. The proposed change has been performed fully in line with the post-approval change management protocol which requires its notification within 12 months following implementation. | |||
| 2. The proposed change has been performed fully in line with the post-approval change management protocol, which requires its immediate notification following implementation. | |||
| Documentation | |||
| 1. Reference to the post-approval change management protocol. | |||
| 2. Declaration that the change is in accordance with the post-approval change management protocol and that the study results meet the acceptance criteria specified in the protocol (1) | |||
| 3. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). | |||
| 4. Results of the studies performed in accordance with the post-approval change management protocol. | |||
| (1) Note: Other changes to or with respect to an in-house reference standards/preparations, not covered by an approved protocol, should be classified in analogy to respective changes affecting the biological active substance/finished product. | |||
#qie6
| Q.I.e.6 Introduction of a product lifecycle management document (PLCM) related to the active substance | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| 1, 2, 3 | II | ||
| Documentation | |||
| 1. The content of the product lifecycle management document has been developed in accordance with the relevant European and international scientific guidelines. Results from product, process and analytical development studies (e.g. interaction of the different parameters, including risk assessment and multivariate studies, as appropriate) demonstrating where relevant that a systematic understanding of how material attributes and process parameters impact the critical quality attributes of the active substance has been achieved. | |||
| 2. The product lifecycle management document includes a description of the material attributes, quality attributes and process parameters (or analytical procedure parameters), their proposed limits and ranges, and future variation reporting categories, in a tabular format. | |||
| 3. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). | |||
#qie7
| Q.I.e.7 Changes related to the active substance in line with an approved product lifecycle management document (PLCM) | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| (a) Major change to the active substance in line with an approved PLCM | 1, 2, 3 | II | |
| (b) Minor change to the active substance in line with an approved PLCM | 1 | 1, 2, 3 | IA |
| (c) Minor change to the active substance in line with an approved PLCM | 2 | 1, 2, 3 | IAIN |
| (d) Minor change to the active substance in line with an approved PLCM | 1, 2, 3 | IB | |
| Conditions | |||
| 1. The change has been foreseen in the product lifecycle management document as a Type IA variation requiring notification within 12 months following implementation. | |||
| 2. The change has been foreseen in the product lifecycle management document as a Type IA variation requiring immediate notification following implementation. | |||
| Documentation | |||
| 1. A summary and justification of the proposed change(s), clearly describing the present and proposed situation and supporting documentation. | |||
| 2. An updated product lifecycle management document (PLCM) with relevant sections modified. | |||
| 3. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). | |||
#qie8
| Q.I.e.8 Changes to an approved product lifecycle management document (PLCM) related to the active substance | Condition to be fulfilled | Documentation to be supplied | Procedure type |
| (a) Major changes to an approved PLCM | II | ||
| (b) Minor changes to an approved PLCM | 1, 2, 3 | IB | |
| Documentation | |||
| 1. A summary and justification of the proposed change(s), clearly describing the present and proposed situation and supporting documentation. | |||
| 2. An updated product lifecycle management document (PLCM) with relevant sections modified. | |||
| 3. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format). | |||
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