iBoske | Post-Approval Changes Decision Wizard

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Michael Rodriguez

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Drug Substance or Drug Product. Drug Product. Drug Substance.
WHO Description of Change #. Process. Raw Materials. Equipment. Facilities. Control Strategy. Cell Banking.
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Question. 2. 5. Change in the cell bank qualification protocol. 2. Change to the cell banks. 2. 3. Change in the cell bank manufacturing site. 2. 4. Change in the cell bank testing/storage site.
None.
"5. No changes have been made to the tests/acceptance criteria used for the release of the cell bank. 7. No changes have been made to the storage conditions used for the cell bank, and the transport conditions of the cell bank have been validated.".
Question. 2. a. Adaptation of a master cell bank (MCB) into a new culture medium. 2. b. Generation of a new MCB. 2. c. Generation of a new working cell bank (WCB).
None.
1. The new MCB is generated from the original clone or from a pre-approved MCB and is grown in the same culture medium..
Question. None. "2. The new cell bank is generated from a pre-approved MCB. 3. The new cell bank is generated from a pre-approved MCB. 4. The new cell bank is released according to a pre-approved protocol/process or as described in the original licence.".
None.
"2. The new cell bank is generated from a pre-approved MCB. 3. The new cell bank is generated from a pre-approved MCB. 4. The new cell bank is released according to a pre-approved protocol/process or as described in the original licence.".
Question. None. 6. The protocol is considered more stringent (i.e. addition of new tests or narrowing of acceptance criteria)..
None.
6. The protocol is considered more stringent (i.e. addition of new tests or narrowing of acceptance criteria)..
Question. Cell Culture. Purification. Storage.
Question. 6. Change to the fermentation or cell culture process.
Question. 6. A critical change (a change with high potential to have an impact on the quality of the drug substance or drug product, e.g. incorporation of disposable bioreactor technology). 6. b. A change with moderate potential to have an impact on the quality of the drug substance or drug product (e.g. extension of the in vitro cell age beyond validated parameters). "6. c. A noncritical change with minimal potential to have an impact on the quality of the drug substance or drug product, such as: a change in harvesting and/or pooling procedures which does not affect the method of manufacture, recovery, intermediate storage conditions, sensitivity of detection of adventitious agents or production scale; duplication of a fermentation train; or addition of similar/comparable bioreactors".
None.
"1. The change does not have an impact on the viral clearance data or the chemical nature of an inactivating agent. 3. There is no change in the drug substance impurity profile outside the approved limits.".
"1. The change does not have an impact on the viral clearance data or the chemical nature of an inactivating agent. 2. There is no change in the drug substance specification outside the approved limits. 3. There is no change in the drug substance impurity profile outside the approved limits. 4. The change is not necessitated by recurring events arising during manufacture or because of stability concerns. 5. The change does not affect the purification process. 7. The new fermentation train is ide.
Question. 7. Change to the purification process, involving the following.
Question. 7. a. A critical change (a change with high potential to have an impact on the quality of the drug substance or drug product, e.g. a change that could potentially have an impact on the viral clearance capacity of the process or the impurity profile of the drug substance). 7. b. A change with moderate potential to have an impact on the quality of the drug substance or drug product (e.g. a change in the chemical separation method, such as ion-exchange HPLC1 to reversed-phase HPLC). 7. c. A noncritical change with minimal potential to have an impact on the quality of the drug substance or drug product (e.g. addition of an in-line filtration step equivalent to the approved filtration step).
None.
"1. The change does not have an impact on the viral clearance data or the chemical nature of an inactivating agent. 3. There is no change in the drug substance impurity profile outside the approved limits.".
"1. The change does not have an impact on the viral clearance data or the chemical nature of an inactivating agent. 2. There is no change in the drug substance specification outside the approved limits. 3. There is no change in the drug substance impurity profile outside the approved limits. 4. The change is not necessitated by recurring events arising during manufacture or because of stability concerns.".
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Question. Process. Raw Materials. Equipment. Facilities. Control Strategy.
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