TEVA Dispatch of Materials PDF

TEVA Title Dispatch of Materials GUIDANCE ON USING THIS TEMPLATE 1. RELATED GLOBAL QUALITY POLICY/STANDARD CORP-0048 Control and Monitoring of Transportation of Pharmaceutical Products within Teva 2. PURPOSE The...

TEVA Title Dispatch of Materials GUIDANCE ON USING THIS TEMPLATE 1. RELATED GLOBAL QUALITY POLICY/STANDARD CORP-0048 Control and Monitoring of Transportation of Pharmaceutical Products within Teva 2. PURPOSE The purpose of this procedure is to ensure that samples and materials dispatched from Teva Larne are correctly packaged and accompanied by the paperwork required by regulatory and customs officials at their destination. 3. SCOPE This procedure details the actions to be followed for the dispatch of materials from the Larne site. Dispatch of clinical supplies is outside the scope of this procedure and is covered by SOPG040752. 4. RESPONSIBILITY It is the responsibility of the person sending the shipment to liaise with the PD Admin / Millicent Logistics (ML) department to determine dispatch dates and shipping requirements. It is the responsibility of the sender to determine whether temperature monitoring is required and to choose outer packaging which will provide adequate protection to ensure that the labelled temperature conditions are met during shipment. It is the responsibility of the person sending the shipment to define whether the material is being shipped for Good Manufacturing Practice (GMP) use. If the material is being shipped for GMP use it will require conditions during shipment to be controlled to maintain CONFIDENTIAL TEVA Title Dispatch of Materials recommended storage conditions in accordance with SOPG039172. It is the responsibility of the person sending the shipment to complete the Export Checksheet applicable and forward a copy to Teva admin along with any additional paperwork who in turn will forward to the ML Administration personnel. If material is shipped under GMP conditions only a carrier from the approved suppliers’ list ADN054608 may be used. GMP can be defined as material that is intended for release for Human use or for testing in GMP stability studies. No shipments should leave Teva without a copy of the applicable checksheet saved in PD Projects folder for future reference. It is the responsibility of Teva Personnel sending the items to complete the Invoice and any additional paperwork as required by Millicent’s procedure MH-00128, take the items to the Warehouse and pack the items for dispatch. If any amendments are required this will be communicated with the ML Department who will inform the sender of what changes are required to be made. If paperwork is correct the Corporate Customs Compliance and Transportation personnel will issue permission for shipment to proceed. Additional ML Personnel responsibilities are detailed in MH-00128. 5. PROCEDURE Note: Examples of the documentation accompanying shipments are shown in MH-00128, and listed on the check sheets. From time to time these documents can change to include additional information; however the main content of the documents will remain the same. ML Logistics personnel will liaise with the necessary departments to determine details of samples or materials to be shipped. The following documentation must accompany all shipments (see MH-00128 for examples and O:\PD\Projects\3-Shipping Paperwork for templates)  A Commercial invoice  End User Letter  Material Safety Data Sheet (MSDS) if applicable  Statement of Animal Origin if applicable  Certificate of Analysis if applicable  Supporting evidence showing how the invoice price of the item was obtained may be required. This list is not exhaustive and the sender should liaise with the recipient to ensure this documentation meets their requirements. 5.1. Preparing the Items for Dispatch The person initiating the shipment will forward the completed checksheet to PD Admin who in turn will liaise with the ML department. The ML department will review the CONFIDENTIAL TEVA Title Dispatch of Materials documentation and forward it to the Corporate Customs Compliance and Transportation Department for approval. If Corporate Customs Compliance and Transportation department require any additional documentation or amendments, they will communicate this via the ML department. Once paperwork has been completed satisfactorily, the Corporate Customs Compliance and Transportation department will issue approval to ship to the ML department, who will inform the sender and shipping company. The person initiating the shipment will bring the item(s) for shipping to the ML department providing suitable labelling, including name, delivery address etc. Adequate packaging and should it be required temperature recording devices will be provided by the ML department for the sender to pack the item(s) to be shipped. Where required, and as specified by the sending department, ML Personnel will prepare any temperature controlled packaging and temperature recording devices that are required and pack appropriately in accordance with SOPG039172. Note: Items should not be sealed to enable the contents to be checked prior to sealing for dispatch. 5.2. Preparation for Dispatch See MH-00128 for details. 6. REFERENCES SOPG039172 Control, Monitoring and Review of In-Transit Temperature Data MH-00053 Dispatch of Clinical Supplies for Teva MH-00128 Dispatch of Materials ADN054608 Approved Suppliers of Services SOPG040752 7. LIST OF APPENDICES None 8. HISTORY Version Description of Change Reason for Change Number 1.0 Overall Document Updated to reflect Glorya references Section 5.0 updated For clarity Appendix A Removed Templates for UK & Europe / US CONFIDENTIAL TEVA Title Dispatch of Materials saved O:\PD\Projects\3-Shipping Paperwork 11.0 Section 4.0 updated For clarity of process LOG-LSD-081 Made Obsolete Appendix A Created Update to include checksheet CONFIDENTIAL