Supply chain

Question 1

Supply chain answer

Answer 1

As the QP I would need to assure myself of
Compliance in GMP
Compliance to submission

I would expect this change to be documented under a change control, an impact assessment will be carried out and all applicable actions captured

I would expect a type 2 variation to be submitted due to the change in supply chain

In order to support the variation I would produce a QP declaration

Information I would need available to me would be:
* API moving to a third country
○ License - GMP certificate, possible CEP
○ Importation - written confirmation from competent authority or white list country
○ Supply - Update to supply chain management, Supply chain map updated and GDP for API
○ Audit - Audit to be carried out in order to produce QP declaration
○ Reference and retains - To be taken for the API
○ Stability or validation studies - Stability studies to be set down of the new API, any validation batches required or analytical method validation, impact to cleaning validation?
○ TA - technical agreements in place with all applicable parties
* Bulk Tablets moving to be manufactured third country
○ License - Licensed to carry out the activity, GMP certificate current
○ Importation - Import testing will be required as manufactured in a 3rd country (samples taken within EU or justification of representative sample)
○ Supply - Update to supply chain management, Supply chain map updated and GDP for bulk tablet shipment to EU
○ Audit - Audit to be carried out of the bulk tablet manufacture as taking overall responsibility for release
○ Reference retains - to be held in EU or EEA
○ Stability or validation studies - Stability studies to be set down of the bulk tabs from new manufacturing site, any validation batches required or analytical method validation, impact to cleaning validation?
○ TA - technical agreements in place with all applicable parties
* Packed in EU
○ License - Licensed to carry out the activity, GMP certificate current
○ Importation - Import testing will be required if manufactured in a 3rd country (samples taken within EU or justification of representative sample), to be imported into the EU prior to certification for release to EU
○ Supply - Update to supply chain management, Supply chain map updated and GDP for shipments
○ Audit - Audit to be carried out at the contract pack site as taking responsibility for overall release
○ Reference retains - to be held in EU or EEA
○ Stability or validation studies - Stability studies to be set down with the new API, any validation batches required or analytical method validation, impact to cleaning validation?
○ TA - technical agreements in place with contract packing site
* QP certified in EU and imported to UK under WDA with RPI oversight

Question 2

Supply chain - API moving to a third country

Answer 2

○ License - GMP certificate, possible CEP
○ Importation - written confirmation from competent authority or white list country
○ Supply - Update to supply chain management, Supply chain map updated and GDP for API
○ Audit - Audit to be carried out in order to produce QP declaration
○ Reference and retains - To be taken for the API
○ Stability or validation studies - Stability studies to be set down of the new API, any validation batches required or analytical method validation, impact to cleaning validation?
○ TA - technical agreements in place with all applicable parties

Question 3

Supply chain - Bulk Tablets moving to be manufactured third country

Answer 3

○ License - Licensed to carry out the activity, GMP certificate current
○ Importation - Import testing will be required as manufactured in a 3rd country (samples taken within EU or justification of representative sample)
○ Supply - Update to supply chain management, Supply chain map updated and GDP for bulk tablet shipment to EU
○ Audit - Audit to be carried out of the bulk tablet manufacture as taking overall responsibility for release
○ Reference retains - to be held in EU or EEA
○ Stability or validation studies - Stability studies to be set down of the bulk tabs from new manufacturing site, any validation batches required or analytical method validation, impact to cleaning validation?
○ TA - technical agreements in place with all applicable parties

Question 4

Supply chain - packed in the EU

Answer 4

○ License - Licensed to carry out the activity, GMP certificate current
○ Importation - Import testing will be required if manufactured in a 3rd country (samples taken within EU or justification of representative sample), to be imported into the EU prior to certification for release to EU
○ Supply - Update to supply chain management, Supply chain map updated and GDP for shipments
○ Audit - Audit to be carried out at the contract pack site as taking responsibility for overall release
○ Reference retains - to be held in EU or EEA
○ Stability or validation studies - Stability studies to be set down with the new API, any validation batches required or analytical method validation, impact to cleaning validation?
○ TA - technical agreements in place with contract packing site