How Should a Pharmaceutical Company Approach Supplier Qualification?

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:

· Quality and compliance: Evaluating products' high quality and supplier’s compliance with the FDA and EMA regulations. 

· Cost: Checking the costs of the products, shipping charges, or any additional services costs. 

· Delivery: Assessing supplier’s lead delivery time, their record of on-time delivery, and if they will be able to deliver bulk and urgent orders in a specific time frame. 

· Customer Service: Reviewing customer service for their technical support and responsiveness. 

Once the preliminary data of suppliers is collected and reviewed, the supply chain management (SCM) team sends a supplier screening questionnaire to get more details regarding raw materials, services, or documentation. 

The filled forms are reviewed, and the final decision is made on whether the supplier is approved or rejected. 

Step 2: On-site Audit

After identifying the top candidate as a potential supplier, the next step is scheduling an audit. It can be off-site if the supplier is providing any basic products or services like disposable equipment, but if the requirement is for vital products, then an onsite audit is inevitable. The on-site audit is performed by qualified auditors consisting of quality assurance and quality control teams well-versed in GMP guidelines who physically visit and inspect the supplier’s facility. 

The on-site audit is based on an audit agenda, which includes assessing the supplier's manufacturing process, quality control procedure, and documentation practices. 

· The first item of the audit agenda is checking the supplier’s compliance with the GMP regulations, which ensure that they can provide high-quality raw materials. 

· The supplier production facility is inspected for cleanliness, storage conditions, and maintenance. 

· The company's product protocols, testing criteria, and review process should also be addressed to the supplier. 

· Another important part is to ensure that the supplier has an alternate source of supply so that the supply chain doesn't get affected in any disaster and that they have robust strategies in place to mitigate unexpected risks. 

· Suppliers must have well-documented risk management plans to help them resume working after any unforeseen circumstances. 

After a detailed review or audit of the supplier's facility, the pharmaceutical company determines the status of the supplier qualification. There are three levels of qualification:

· Qualified: Supplier is evaluated and meets the GMP standards in terms of quality. 

· Conditionally qualified: In this status, the supplier has some performance issues and it should work on meeting that specific requirement to be on the approved list.

· Disqualified: This supplier is unreliable and is removed from the list.

Step 3: Onboarding Supplier in Supply Chain 

After thoroughly reviewing quality standards and completing audits, a nondisclosure agreement is signed between the supplier and the pharmaceutical company. This process is known as onboarding. At this stage, the concerned pharmaceutical company is convinced that the supplier is well-equipped to provide top-quality products and counter any risks. Continuous compliance with industry standards helps companies build a solid working relationship with the supplier 

Supplier qualification doesn't end with onboarding - the next step is tracking the supplier’s performance, which includes product quality review and on-time delivery. Collective workshops should be organized, and provide training for companies' risk management policies.

Step 4: Re-qualification 

Re-qualification is a process where a previously qualified supplier undergoes a reassessment to ensure that they continue to meet the required standards and specifications. Re-qualification is essential to maintain the quality and reliability of supplied materials or services overtime. The process includes reviewing the supplier’s performance, conducting audits, and ensuring compliance with current regulations and industry standards.

Re-qualification should be done from time to time to affirm the supplier’s compliance with all the regulations set at the beginning of the contract. The best practice is to set some key performance indicators (KPIs) and then monitor their performance against it. The recommended time frame for re-qualification is at least once a year. However, approval or rejection should be based on the testing of almost 30 batches of samples. If they still meet the company's standard of providing quality materials, timely delivery, ability to provide bulk material, and customer service that abides by the company’s policy, then the supplier continues working with the company.

Conclusion

Selecting a supplier for a pharmaceutical company is a critical step in the supply chain process. The process is based on finalizing suppliers that efficiently comply with the GMP standards and provide high-quality products and services as per the requirements.