Please create a procedure based on the provided work flow chart in the attachment and please use the template provided for proper formatting.
This procedure describes the process to follow when requesting purchases intended for manufacturing use by the InstantGMP™ Manufacturing Site.
This procedure applies to all persons involved with purchasing materials for the InstantGMP™ Manufacturing Site.
3.1. The Project Manager is responsible to assure this procedure is followed, remains consistent with current practices and is reviewed and updated as necessary.
3.2. The Project Manager is responsible for ensuring the correct goods are requested for each production batch.
4.1. SOP-0212 – Program to Qualify Vendors
5. BUSINESS REQUIREMENTS
5.1. Only materials for the selected Vendor are available in the Material field.
5.2. Only one vendor per requisition.
5.3. Only Materials Specifications that have been approved by a Quality Manager QM can be selected in the Part Number field.
5.4. Unit size does not covert (e.g. from mL to Liter, or from Liter to mL). The unit size in the Inventory must be the same used in the Master Production Record.
5.5. Only Project Managers assigned to the Project can approve a requisition for that project.
5.6. Once a Requisition is marked “complete” it can not be edited.
5.7. Marking “complete” creates an entry for each material in the Material Receipt section.
5.8. The system will allow a user to build a requisition using materials from a single vendor.
5.9. The system will allow a user to assign specific details to each material within a requisition.
5.10. The system will assign a unique requisition number for each requisition created.
5.11. The system will allow a user to flag a requisition as “sent” (to a vendor) at which time it should no longer be editable.
5.12. The system will allow the user to create a PDF version of the requisition in the form of a Purchase Order.
5.13. The system will allow a user to record the receipt of a material, which will be added to the inventory.
5.14. The system will allow a user to search for a material based on either Part Number or Receipt Number when recording material receipt.
5.15. The system will assign a unique receipt number for each material received per requisition.
5.16. The system will enforce the entry of a digital signature to save a material receipt record.
5.17. The system will allow a user to enter status details for each receipt number; in the inventory.
Note: A receipt number refers to a material from a specific requisition.
5.18. The system will allow a user to record inventory usage details for each receipt number in the system.
5.19. The system will display the history of inventory usage records and the inventory balance for each receipt number.
5.20. The system will allow a user to enter an inventory usage record using comparable units (i.e.: gm/mg; mL/L) and properly record the inventory balance in the default unit for that receipt.
5.21. The system will perform a validation check to ensure that no materials in a BPR’s Bill of Materials are depleted when issuing the BPR.
|Responsible Party||Action Step|
|Project Manager||Check the InstantGMP™ electronic system to confirm that the vendor is qualified, if applicable. If not, qualify per SOP-0212, Program to Qualify Vendors.|
|Enter material purchase information in the Requisition menu in the InstantGMP™ electronic system by clicking on “Requisition” then “Build Requisition”. Click on the desired specification number, then “add to requisition”.|
|If a Certificate of Analysis/Conformance (C of A or C of C), or MSDS is required with receipt, complete the check boxes on the build requisition screen.|
|Assemble the requisition, assure the correct version of the specification is used.|
|Obtain internal approval of the Purchase Requisition if applicable.|
|Forward to the Purchasing Agent for the facility.|
|Purchasing Agent||Review the Purchase Requisition.|
|Place the order by contacting the vendor listed.|
|Ensure that the specification provided by the Project Manager goes to the vendor, if applicable.|
|Request that the PO number be included on each packing slip.|
|Notify the Requestor of:Any modifications to the request.Estimated date of delivery.Complete order not available, on back order, or delayed.|
|VERSION||EFFECTIVE DATE||DESCRIPTION OF CHANGE|
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