Suppliers are a critical component in the life cycle of a pharmaceutical product. A supplier is an individual or an organization supplying materials in large quantities or services to other manufacturing companies. Choosing the “right” supplier for sourcing raw materials, components, or services is both a need and a regulatory requirement.
In this article, we will discuss in detail what supplier qualification is, and how pharmaceutical companies can approach supplier qualification. So without further ado, let's dive in.
What is Supplier Qualification?
Pharmaceutical companies select suppliers through a process called Supplier Qualification. But what is supplier qualification?
Supplier qualification is a process through which suppliers are assessed whether they can 'supply' the products to a pharmaceutical company according to their requirements.
Supplier qualification is necessary to avoid any adverse effects due to the risk of low quality products since the use of substandard raw materials can cost business, trust, and the lives of the masses.
Supplier Qualification Process
Supplier qualification is a stepwise process, starting from the identification of requirements and going all the way through a pre-audit and main audit before choosing a supplier.
Step 1: Identification of Specific Requirements For Suppliers
The first step in the qualification process is identifying what the company requires from the supplier - be it specific products or services, quality standards, or other technical requirements that the company needs.
Identification is followed by conducting a thorough market research to gather information about potential suppliers. It can be done by asking industry professionals, and checking pharmaceutical directories or online databases. The preliminary data needed to select suppliers include past reviews, history, location, relationship with other companies, and material or goods they supply before finally reaching out to the supplier to assess their willingness for the partnership.
The next step is risk screening of suppliers in which the financial health of the supplier, risks related to geographical location, their past regulatory compliance, and their ability to meet the company's demands are assessed. Risk screening helps develop criteria for which suppliers are reviewed, such as:
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