The process of vendor qualification is an essential aspect of the pharmaceutical and biopharmaceutical industry. It involves evaluating vendors to determine if they can provide the necessary goods or services to the standards that the purchasing company requires. Poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company. Therefore, it is crucial to develop a practical and compliant vendor qualification program.
Vendor Qualification and Quality Systems
- The qualification process is defined as "the process of demonstrating whether an entity is capable of fulfilling the specified requirement." Before discussing the best approach to qualifying different types of vendors, it is important to first understand the concept of quality systems.
- Quality systems are defined as "the processes, organizational structure, procedures, and resources that are used to control variables associated with producing a product of consistent quality and that meet predefined specifications." In simpler words, an organization's entire operation is a measure of a product's quality and not simply the testing of its finished product.
- Once these user requirements are defined, candidate athletes are identified. After identifying the top prospect (or prospects) on paper, a selection is made. However, the process is far from over at this point. The selected individual (or individuals) is then physically and mentally evaluated by team doctors to determine his readiness to play professional football for that specific team. Only after successful fulfillment of the team's specific financial, physical, and mental requirements is the player contracted.
- However, as many are aware, this one-time assessment does not guarantee consistent performance throughout the player's contract. Therefore, the athlete's performance is regularly assessed to ensure continued ability to meet the needs of the team. If the professional cannot meet the team's current requirements, he is subjected to performance improvement training and risks being traded or released.
- Similar to the professional football candidate, a potential vendor should be thoroughly assessed against a company's requirements, compared to other candidate vendors, physically evaluated once selected (and before a contract is signed), and reevaluated as required and as defined regularly. This article presents the Q.U.E.S.T. approach as a simple, effective, and compliant approach to vendor qualification.
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Vendor qualification – the Q.U.E.S.T. approach
- Vendor qualification is not solely an auditing process but rather a quality system in itself for the pharmaceutical or biopharmaceutical organization. The Q.U.E.S.T. approach is a simple, effective, and compliant approach to vendor qualification. The Q.U.E.S.T. approach stands for Question, Understand, Evaluate, Site Audit, and Track.
- The first step in qualifying a vendor is for the pharmaceutical or biopharmaceutical company to document its needs from a vendor of this type. Once the Question Phase is complete, vendors that appear to meet the company's requirements are contacted directly to gauge interest in being a new vendor for the company.
- The company's requirements (as defined in the Question Phase) are then supplied to those interested vendor organizations. It should be requested that the vendor supply all its administrative information, applicable sales and marketing materials, and most importantly, documentation that supports its ability to meet the specified company requirements.
- Once the Question Phase is complete, vendors that appear to meet the requirements are contacted directly to gauge interest in being a new vendor for the company. The company's requirements (as defined in the Question Phase) are then supplied to those interested vendor organizations.
- It should be requested that the vendor supply all its administrative information (e.g., key contacts, location(s)), applicable sales and marketing materials, and most importantly, documentation that supports its ability to meet the specified company requirements (including, but not limited to, pricing). At this time, it should also be requested that the vendor send a "sample" of the product or service that it will potentially provide.
- For example, a lactose supplier should be requested to supply samples of the lactose that it would offer for sale in addition to the certificates of analyses for the lactose. A bioreactor supplier should provide pictures of the vessel along with all the vessel specifications. Even a consulting or contracting organization should provide samples. These organizations should provide sample resumes of resources that would be involved in the pharmaceutical or biopharmaceutical company's projects.
- Once at least three vendors have been identified to meet the company's requirements, it is time for vendor evaluation. First, each vendor is assessed against the company requirements as specified in the Question Phase. All of the potential vendors previously identified will be able to meet each and every requirement specified—vendors that could not meet the requirements have already been eliminated. This evaluation pertains to how well each vendor meets each requirement when compared to the other short-listed vendors.
- The next-to-last phase in the vendor qualification process involves a site audit of the potential vendor's facility. As the cost of an audit is a potentially pricey activity, the site audit may be performed onsite or offsite depending on the criticality of the potential vendor type and is limited to the best potential vendor identified in the Evaluation Phase. Vendor types need to be divided into critical and non-critical suppliers. A critical vendor supplies goods or services that directly control or dictate the quality and integrity of pharmaceutical and biopharmaceutical products. A non-critical vendor supplies goods or services that assist and support the quality of these products.
- In conclusion, the Q.U.E.S.T. approach is a simple, effective, and compliant approach to vendor qualification. It is important to understand the concept of quality systems and to develop a practical and compliant vendor qualification program to ensure that the purchasing decisions made by pharmaceutical and biopharmaceutical companies are well-informed and documented.
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