Globalization and intense competition have revolutionized logistics in the chemical and pharmaceutical industry. Unfortunately, cases of lack of safety for patients have arisen and, on many occasions, ethical doubts that need to be addressed when relying on external factors. The right way to react to these situations is through supplier qualification, a process in which RC REDOL has the competencies to support its clients. Learn more about this essential activity to modern pharmaceutical production in the article below.
Supplier qualification is a process of evaluation, selection, and monitoring of suppliers. It is essential because only by identifying suppliers that offer products and services that guarantee the satisfaction of legal and buyer’s requirements and thus be able to guarantee the quality and safety of their products. It is also an important activity for ensuring the conformity of your production, identifying suppliers for development programs, driving continuous improvement through the supply chain, and contributing to successful development programs.
The objective of supplier qualification is to ensure that chosen suppliers must consistently meet the buyer’s requirements and deliver high-quality products or services, on time and at a competitive price. In this process, Supplier Qualification is carried out for a specific material/service and manufacturer. In other words, different materials/services supplied by the same Supplier need to go through different Qualification processes.
In this scope, the Supplier Qualification process is divided into 3 main phases: Acquisition (Selection), Qualification (Approval), and Requalification (Monitoring). In the acquisition phase, the requirements are defined, such as technical specifications, regulatory requirements, and purchase requirements. Then, evaluation and selection involve processing supplier information/documentation, evaluation of regulatory certificates and material analysis certificates, but also sample evaluation, method evaluation, questionnaire evaluation, and supplier audit, if available and applicable. After qualification, it has to be ascertained whether the Suppliers continue to be qualified over time and these Suppliers are therefore monitored on an ongoing basis.
On the other hand, different methodologies are applied when assessing supplier qualification, namely:
Supplier Monitoring:
- Monitors the supplier’s quality/HSE system and the performance of what they provide to Customers (in terms of quality);
- Identifies the Suppliers who need our collaboration to improve their performance.
- Indicates the level of quality control required to release raw materials or packaging (indirect materials not applied)
- Is measured continuously and reported on a periodic basis (e.g. monthly).
Supplier Evaluation:
- Grades Suppliers on a percentage scale considering their systems and performance history on a wider range of criteria.
Supplier Qualification is a process with high technical demands and needs experienced and specialized human resources to conduct it. Therefore, it is a service that can be subcontracted and RC REDOL is the ideal partner for these processes. We can easily evaluate a supplier’s performance in terms of quality, delivery, and general reliability, as well as its performance and consistency of products or services. Don’t leave a process, as vital as this, in the hands of unqualified personnel and opt for our services instead, to get the real pulse of your suppliers.
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