Many GMP requirements focus on the vendor qualification process, particularly because it can significantly impact the quality of manufactured products. Vendor qualification requirements include:
The need to provide evidence that suppliers are monitored and regularly scrutinized.
Tracking by approval status of vendor-item.
Definition of quality inspection upon item receipt, depending on the state of the vendor-item.
The list of available statuses for approved vendors is defined in Life Sciences Quality Control & Assurance > Setup > Quality control > Vendor statuses.
Life Sciences Quality Control & Assurance supports the above requirements by allowing for the definition of the vendor status (for example, Qualified or Under qualification) in the approved vendor list by item (Product information management > Products > Released products > Purchase tab > Approved vendors) and in quality associations (Life Sciences Quality Control & Assurance > Setup > Quality control > Quality associations).
The approved vendor list is used to define the list of vendor accounts approved for the item. Upon purchase order creation, the system verifies the vendor against the purchased item, and it can return a warning or error message based on the desired level of control (that is, Vendor check method). Please refer to the Implementation Guide for Life Sciences Supply Chain Management for further details on the supplier qualification functionalities.
When a record is created in the approved vendor list, an authorized user can select a vendor status for each item-vendor combination.
Quality associations for purchased materials are integrated with the vendor’s qualification process. It is possible to configure quality associations by:
Item, group of items, or all items;
Vendor, group of vendors, manufacturers, or vendors with a certain status (see example below).
Example
Item “RM001 – Raw material 001” has the following vendor accounts in the approved vendor list:
Vendor “VEND001”, in status Qualified
Vendor “VEND002”, in status Under qualification
Quality association #1 is configured as follows:
Reference type: Purchase
Item number: “RM001 – Raw material 001”
Criteria:
Vendor: All
Vendor status: Qualified
Test group: “TG001-1”
Quality association #2 is configured as follows:
Reference type: Purchase
Item number: “RM001 – Raw material 001”
Criteria:
Vendor: All
Vendor status: Under qualification
Test group: “TG002-1”
If a batch of item “RM001” is received from vendor “VEND001”, the system generates a quality order according to quality association #1 (that is, with the tests available in test group “TG001-1”). If the batch is received from vendor “VEND002”, the system generates a quality order according to quality association #2 (that is, with the tests available in test group “TG002-1”).
Having different quality associations by vendor status allows differentiating product specifications, sampling plans, and reduced testing policies based on vendor status.