checked to make sure that they are consistent with each other. 12.3 1958-1970 The technical transfer of testing methods does not Suggest change section title to: distinguish between requirements for investigational vs. Technical transfer of testing methods for authorised authorised ATMPs. We consider that the expectations given here should be specific to authorised ATMPs or certainly not prior to Phase III. 12.3 1958ff There is no text here covering the qualification of test Suggest include an bullet: methods at the receiving laboratory prior to the transfer Qualification of the test method at the receiving protocol which would focus on equivalence. laboratory prior to the technical transfer 12.4 1972 For certain products, e.g. autologous products where the After the marketing authroisation is granted, unless entire quantity of each batch is dosed back to the patient, justified and agreed otherwise, a programme should it might not be possible to have an ongoing stability be implemented... monitoring program. This would be an exception agreed to as part of the marketing authorisation. 12.4 c. 1987 Following on from the above, suggest that where it is Suggest new sentences in between current sentences in not possible to perform ongoing stability studies, the line 1987 or nearby: proposed shelf life should be covered as part of the ... otherwise justified. For autologous products where process validation with consideration of the use of ongoing monitoring using finished product batches is surrogate material batches to provide ongoing supporte not appropriate, the shelf life should be covered as part of process validation. Consideration should be given to manufacturing periodic batches with surrgogate materials for additional ongoing assurance. Out of specifications... 14.2 2046-2053 This section is very light cf.the expectations in Suggest adding: EudraLex Volume 4, Part I, Chapter 8. To the end of current text in line 2049: The recall procedure should be regularly reviewed It is suggested that, as a minimum, the following should and updated when necessary. The effectiveness of the recall arrangements should be periodically evaluated to be added: confirm that they remain robust and fit for use. Such The need for periodic testing of the recall process; evaluations should the possibility of recall both The need for appropriate segregation of recalled within and outside of normal office hours. product; Consideration should be given to performing mock The need for a report to be issued following a recall recalls. These evaluations should be documented and justified.
checked to make sure that they are consistent with each other. 12.3 1958-1970 The technical transfer of testing methods does not distinguish between requirements for investigational vs. authorised ATMPs. We consider that the expectations given here should be specific to authorised ATMPs or certainly not prior to Phase III. Suggest change section title to: Technical transfer of testing methods for authorised 12.3 1958ff There is no text here covering the qualification of test methods at the receiving laboratory prior to the transfer protocol which would focus on equivalence. Suggest include an bullet: Qualification of the test method at the receiving laboratory prior to the technical transfer 12.4 1972 For certain products, e.g. autologous products where the entire quantity of each batch is dosed back to the patient, it might not be possible to have an ongoing stability monitoring program. This would be an exception agreed to as part of the marketing authorisation. After the marketing authroisation is granted, unless justified and agreed otherwise, a programme should be implemented... 12.4 c. 1987 Following on from the above, suggest that where it is not possible to perform ongoing stability studies, the proposed shelf life should be covered as part of the process validation with consideration of the use of surrogate material batches to provide ongoing supporte Suggest new sentences in between current sentences in line 1987 or nearby: ... otherwise justified. For autologous products where ongoing monitoring using finished product batches is not appropriate, the shelf life should be covered as part of process validation. Consideration should be given to manufacturing periodic batches with surrgogate materials for additional ongoing assurance. Out of specifications... 14.2 2046-2053 This section is very light cf.the expectations in EudraLex Volume 4, Part I, Chapter 8. It is suggested that, as a minimum, the following should be added: The need for periodic testing of the recall process; The need for appropriate segregation of recalled product; The need for a report to be issued following a recall Suggest adding: To the end of current text in line 2049: The recall procedure should be regularly reviewed and updated when necessary. The effectiveness of the recall arrangements should be periodically evaluated to confirm that they remain robust and fit for use. Such evaluations should the possibility of recall both within and outside of normal office hours. Consideration should be given to performing mock recalls. These evaluations should be documented and justified.