In small organisations, where teams are multi-skilled and trained in both QC and production activities, it is acceptable that a person is responsable for one of these roles (production or quality control) for a given batch, and for the other role for a subsequent batch. At no time is it aceptable for a person to perform both roles for a single batch. the same person is responsible for both roles (production and quality control) with respect to different batches. 4.2 468/469 Suggest additional wording to make it clear that this is Proposed amended text: Segregated production areas (see Section 9.4(i)) should be not an exhaustive list of manufacturing activities used for the manufacturing of ATMPs presenting a risk requiring segregated areas. that cannot be adequately controlled by operational and/or technical measures. Specifically, Examples of manufacturing activities that should be undertaken in segregated areas would include those involving infectious viral vectors (e.g. oncolytic viruses) or materials from infected donors4 should be done in a segregated area. 4.2 469 / Via footnote 4, reference is made to current donor Footnote 4 testing requirements. However, these requirements may change in the future (e.g., addition of Zika virus testing). It will therefore be important for appropriate trigger mechanisms to be in place to revise this guidance document in the event that this happens. 4.2 472-474 Suggest add wording to this sentence to help explain Proposed added text: why it is here. before any subsequent manufacturing in the same area … can (segregation in time) 4.2.1 461-462 As ATMPs include a wide range of products the request Proposed change of this sentence: In a multi-product for a dedicated manufacturing area should be based on facility, based on a risk assessment a dedicated area the risks of a specific product, not on a formal may be needed to manufacture a specific authorised classification of ATMPs/non-ATMPs. ATMP. 4.2.1 487 - 490 Air change rates should also be considered as part of the Additional sentence following current text, Line 490: design of the facility and it is suggested that this is Appropriate air change rates should be part of the stated explicitly within this paragraph or the preceding design and qualification. one.
In small organisations, where teams are multi-skilled and trained in both QC and production activities, it is acceptable that a person is responsable for one of these roles (production or quality control) for a given batch, and for the other role for a subsequent batch. At no time is it aceptable for a person to perform both roles for a single batch. the same person is responsible for both roles (production and quality control) with respect to different batches. 4.2 468/469 Suggest additional wording to make it clear that this is not an exhaustive list of manufacturing activities requiring segregated areas. Proposed amended text: Segregated production areas (see Section 9.4(i)) should be used for the manufacturing of ATMPs presenting a risk that cannot be adequately controlled by operational and/or technical measures. Specifically, Examples of manufacturing activities that should be undertaken in segregated areas would include those involving infectious viral vectors (e.g. oncolytic viruses) or materials from infected donors4 should be done in a segregated area. 4.2 469 / Footnote 4 Via footnote 4, reference is made to current donor testing requirements. However, these requirements may change in the future (e.g., addition of Zika virus testing). It will therefore be important for appropriate trigger mechanisms to be in place to revise this guidance document in the event that this happens. 4.2 472-474 Suggest add wording to this sentence to help explain why it is here. Proposed added text: … before any subsequent manufacturing in the same area can (segregation in time) 4.2.1 461-462 As ATMPs include a wide range of products the request for a dedicated manufacturing area should be based on the risks of a specific product, not on a formal classification of ATMPs/non-ATMPs. Proposed change of this sentence: In a multi-product facility, based on a risk assessment a dedicated area may be needed to manufacture a specific authorised ATMP. 4.2.1 487 - 490 Air change rates should also be considered as part of the design of the facility and it is suggested that this is stated explicitly within this paragraph or the preceding one. Additional sentence following current text, Line 490: Appropriate air change rates should be part of the design and qualification.
ebe_efpia.docx