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 ...
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