Outsourced Supplier Quality 

Supplier quality is a supplier’s capability to provide goods or services that will fulfil customers’ needs. Supplier quality management is the system where supplier quality is accomplished through a proactive and collective approach.  

Outsourced Supplier Quality refers to the practices, controls, and supervision that a business must guarantee that the goods, parts, or services that the third-party suppliers provide follow accepted quality, safety, and other regulations. According to ISO 9001:2015 and ISO 13485:2016, the company is still responsible for quality even though the supplier is external. This means that the outside supplier must be treated as an integral part of the internal quality management system.  

A company needs to follow specific guidelines and requirements when selecting a supplier or third-party contractor for goods, materials, or services. The importance of the supplier qualification process cannot be overstated. For example, Active Pharmaceutical Ingredient (API) manufacturers and suppliers, Contract Research Organizations (CRO), Contract Development and Manufacturing Organizations (CDMO), Contract Packaging Organizations (CPO), and Contract Laboratory Organizations (CLO) need this process. 

Why is Outsourced Supplier Quality important? 

As per the existing Good Manufacturing Practice (GMP) regulations, Supplier Quality Outsourcing should be considered a pivotal part of the validation of the right suppliers for the organization. Outsourcing of Supplier Quality is compulsory in the life sciences and pharmaceutical sector. The life sciences and pharmaceutical industries produce medicines and other goods and thus need to abide by all the industrial and regulatory norms. Hence, it is essential for companies to choose the right supplier, which is done after careful evaluation and qualification. 

A company must be sure that in its functioning it is taking the right decisions, so outsourcing Supplier Quality to a third party is vital. By doing so, they can be sure that their suppliers are on par and they’re getting the best possible products and services. 

Requirements of Outsourced Supplier Quality 

All outsourcing movements that assist GXP require approval from authorities. The rules are governed by various regulators such as Health Canada, the EU and the FDA, meaning that manufacturers must make sure that suppliers have licenses and QMS. 

Here, supplier qualification is of critical importance as they must produce materials as needed according to current GMP regulations. Furthermore, this process allows understanding whether the supplier can meet the requirements consistently. 

To ensure compliance, the company should organize and conduct audits at a few supplier locations. The supplier should comply with the GXP requirements stated in the contract. In case the supplier considers implementing changes that can affect the GXP status of the products produced/ tested, he should inform the manufacturer about those changes in advance to allow assessment of their impact. Also, the supplier must inform the manufacturer immediately if they discover any deviation from the requirements of the manufacturer that can influence the services provided.  

The supplier qualification process is important in ensuring that your products meet the highest quality standards.