The international supply chain is vulnerable to many risks. It is affected by several factors, such as increased demand from pharma manufacturers, innovation in the manufacturing process, and reduced time to market a pharma drug product from development stage to commercial manufacturing. Additionally, the supplier of a single material comprises different intermediate supply components where retaining quality in each sub-component or stage becomes necessary. The suppliers also have to show and prove the quality of their supplies, which is evaluated by pharma organizations before buying their goods. 

Supplier qualification is a technique to ensure the quality of the material or item supplied by a supplier. It is used by the material buyer to evaluate individual supplier's ability to withstand quality parameters and standardization techniques. Sourcing is an integral part of the pharma industry, and if quality system is not supplied, it can affect the pharma product life cycle and, ultimately, the final output product. 

What is the supplier's qualification?

Supplier qualification is a process of scrutinizing pharma material suppliers. It is a series of activities to ensure a supplier meets pharma-related criteria and standards. Pharma organizations use it to select, review, and approve the pharma material supplier.

Supplier qualification is a mechanism or tool through which a pharma material buyer assures the supplied material will maintain the final and intermediate production process and product quality. The supply is free from any vulnerability and variation. 

What materials are subject to supplier qualification?

Supplier qualification is performed for all materials, items, and services that can become part of a pharma production process and includes the following.

Manufacturing materials

It includes materials used in manufacturing a pharma product, such as active ingredients, excipients, and raw materials.

Packaging material

I include material used to pack a finished pharma product, such as ampoules, labels, and cartons. 

Services

It include the items used to provide service for several processes in manufacturing, such as contract manufacturing and calibration services.

The regulatory perspective

Apart from the advantages it offers, supplier qualification is a regulatory requirement. Let's see some guidelines about supplier qualification. 

The ICH Q10 Guidelines

The ICH Q10 guidelines are rules for implementing quality systems in the pharmaceutical industry. Section 2.7, "Management Of Outsourced Activities And Purchase Material," emphasizes control and review of outsourced services and goods as part of quality systems. 

It requires all pharma manufacturers to ensure the quality of the supplied material by 

● Often conducting supplier audits and qualifications before outsourcing to ensure their suitability and competency. 

● These activities should be part of an agreement between pharma manufacturers and suppliers, and supplier must fully cooperate during qualification activities, and must not create any difficulties. 

● The pharma manufacturer is also responsible for monitoring the supplier's performance and must identify any areas of improvement.

● The pharma manufacturer is also responsible for monitoring the source of supplied items to ensure they do not come through an unapproved supply chain. For example, if other than approved supplier offers the same material at cheaper rates, it must be considered with proper supplier qualification. 

 EU - GMP

The EU-GMP is the European Union's regulatory body and contains regulations related to supplier qualification. The raw materials are mentioned as starting materials for the EU-GMP.

Its Volume no. 4, "EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use' describes the requirement in Part 1, Chapter 5: "Production," and states the following.

● The selection, qualification, and approval of the suppliers of starting materials, including the purchase and acceptance, should be documented, and the management level should be proportionate to the risk level of the individual material.

● For the approval of the supplier of the active substance

o An audit should be carried out at the manufacturer site to confirm their compliance with GMP

o An audit of appropriate duration should be performed to ensure effective compliance with GMP. 

o Audits should be performed regularly to ensure their effectiveness and continuous usage of a respective supplier.

For the supplier of excipients

● Excipient suppliers should be controlled according to the assessment performed by the European Union guidelines on "Formulated Risk Assessment For Ascertaining The Appropriate Gmp For Excipients Of Medicinal Products For Human Use."

Packaging material

For packaging materials, the same procedure should be followed for selection, qualification, approval, and maintenance for suppliers that have been followed for starting materials.

How to perform supplier qualification

Supplier qualification is performed for a new supplier when existing qualified suppliers cannot supply the required material. Let's look at a typical supplier qualification, although it can be adapted to varying requirements.

Defining your requirements

This is the initial stage of a supplier qualification process, where requirements are defined and a supplier knows its role and responsibilities. Requirements can include the following.

● What is the type of supplied item, whether it is a material or a service, such as a packaging material or raw material for manufacturing parenteral product

● What are the necessary regulatory requirements that a supplier must follow? For example, if a buyer is located in the United States, and the supplier is located in Europe, the supplier must also comply with the regulations of the United States.

● What are the product attributes and quality requirements?

● What are the technology, working, and output capabilities of the supplier?

Supplier selection 

After setting your requirements, select a supplier that can fulfill the organizational requirements. It can be done in various ways, such as

● Directly reaching out to the potential supplier through its agent or by using official communication channels

● Supplier reputation in the market

● Reaching to other customers of that particular supplier in the market

Evaluate

Evaluate the suppliers from the selected list according to the requirements they fulfill and essential specifications, quality, and acceptance criteria. 

Monitoring

After shortlisting suppliers, make arrangements to continuously monitor their performance, quality level, and output capacities. Suggest any preventive or corrective action to overcome shortcomings, if required.

Regular performance monitoring

After the supplier is finalized, regularly monitor its performance to ensure it can provide the required quality level regularly rather than at a single time.

Why does the supplier need a qualification?

Supplier qualification offers a variety of benefits, which are described below.

Authentic suppliers

Supplier qualification enables pharma material buyers to identify actual and real suppliers and prevent material from being supplied from counterfeit and tampered item suppliers. Additionally, an organization's supply chain can be impressed with marketing techniques; qualification helps to sort out actual and provides a realistic view of the reliability and quality of the supplier.

Controlling risks

As discussed earlier, the global supply chain is poised for evolving risks that can hamper the production process and, in turn, supply essential drug products to needy patients. The supplier qualification helps to mitigate and protect against these risks and maintain quality. 

Qualification for suppliers provides an overview to the Pharma manufacturer about the supplier's ability to make such arrangements. It also provides opportunities for the supplier to know about the manufacturer's requirements, capabilities, and what areas require improvement, upgrade, or change.

Urgent requirement

It is often the case in the pharma industry to plan production activities due to many reasons, such as urgent market demand and emergencies. In this case, pharma organizations urgently require items and materials, and the availability of raw materials is crucial for timely production. 

If the items or materials need to be sufficiently available in the organization's inventory, a supplier's role is crucial in urgently supplying the required materials. 

A qualified supplier is expected to deliver goods if needed in emergencies. Because, during qualification, the ability to provide materials and items in emergency conditions is verified. This allows the management of items or materials on urgent requirements, enabling a pharma organization to complete its target production.  

Cost-effectiveness

Supplier qualification enables a pharmaceutical manufacturer to inspect, review, and verify the supplier's capabilities at the beginning and at a fixed frequency, allowing the pharmaceutical organization to receive materials continuously and promptly.

In contrast, if the supplier has not qualified, it will become difficult for the pharma organization to receive materials when required. When the material is needed, the pharma manufacturer has to prepare a supplier each time, and this increases the underlying cost of qualification for reasons such as extensive traveling and spending time and money looking for new suppliers. 

On the other hand, if a supplier has been properly qualified initially, it eliminates the need for inspection, fulfilling regulatory steps, and proposing improvements every time an item is required. It also reduces the associated cost and provides a cost-effective source of materials for the pharma organization.

Regulatory fulfillment

Supplier qualification is a critical regulatory requirement for most competitive pharmaceutical markets, such as the United States and Europe. They require Pharma manufacturers in their areas of jurisdiction to perform supplier qualification properly. Each regulatory body has clear and direct instructions on completing a supplier qualification, and failure could result in a warning letter or a fine.

Establishing a proper supplier qualification program helps pharma manufacturers prevent warnings and fines. It also helps a pharma manufacturer prove the regulatory fulfillment and commitment towards regulations.

About the Author:

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.