If you work in the life science industry, you know how important it is to maintain the highest standards throughout your product’s life cycle – from ideation to the end user. A crucial component of this life cycle is the “supplier.” The supplier provides the raw materials or products used in the manufacturing process.   

In today’s business world, companies are outsourcing supplier qualifications and auditing. But what is the best way to go about this? There are many factors to consider and choosing a suitable supplier qualification and auditing partner is essential.   

This blog post will explore some critical considerations for outsourcing supplier qualification.  

What is “supplier qualification”?  

The process by which your company chooses the right supplier or third-party vendor for components, raw materials, or services based on your requirements and regulatory guidelines is known as supplier qualification. At PSC Biotech, we provide this service globally through different types of audit processes. Supplier qualification are essential to ensure you receive the best products and services that meet or exceed regulatory expectations. For example, Active Pharmaceutical Ingredient (API) manufacturers and suppliers, Contract Research Organizations (CRO), Contract Development and Manufacturing Organizations (CDMO), Contract Packaging Organizations (CPO), Contract Laboratory Organizations (CLO), service providers such as calibration and record keeping require supplier qualification process.  

  

three people working in yellow safety gear

Why is supplier qualification important?

According to Good Manufacturing Practice (GMP) regulations, supplier qualification is a crucial part of the validation process when choosing the right supplier for your company. Supplier qualification a regulatory requirement. Life science and pharmaceutical companies research, develop, manufacture, and sell products affecting humans directly. Therefore, it is important to maintain the highest industry and regulatory standards. And for this reason, you must choose the right supplier after a thorough evaluation and qualification process.

When it comes to your business, you want to be confident that you are making the best decisions possible. Therefore, it is important to outsource supplier qualification and auditing to a trusted third party. By doing so, you can be sure that your suppliers are up to par and that you’re getting the best possible products and services for your money.

There are several factors to consider when qualifying and auditing suppliers. With PSC Biotech, you can be sure that all the necessary boxes are checked. Here are just a few of the things that we can do for you:

1. Review the supplier’s procedures.
2. Make sure that the supplier has the proper licenses and permits.
3. Conduct on-site inspections of the supplier’s facilities.
4. Verify that the supplier is using the latest technology.
5. Review the supplier’s customer satisfaction levels.
6. Conduct random audits of the supplier’s products and services.
7. Ensure the supplier complies with all applicable laws and regulations.
8. Provide a detailed report of our findings and observations.
 
two workers one in a yellow hard hat one holding machine part talking over plans

Requirements of Supplier Qualification

All outsourcing activities supporting GXP activities require regulatory approval. All regulatory requirements, either by Health Canada, EU guidelines, or FDA, requires manufacturers to ensure that their suppliers have the proper licenses and follow the quality management system (QMS).

Supplier qualifications are important to ensure that your supplier can provide the materials and components your company needs following the current GMP regulations. In addition, this process ensures that your supplier can consistently meet your quality standards.

To ensure compliance with your requirements, your company will plan and execute your selected supplier’s audits. The supplier must comply with all GXP requirements specified in your contract. For example, suppose the supplier wishes to make any changes that could affect your products’ GXP status or production and testing parameters. The supplier will notify you in advance so that you can assess the impact of the proposed changes. Similarly, the supplier will inform you immediately if they discover any deviation from your requirements that could affect the quality of the services they provide. As necessary, all deviations will be investigated, and corrective action will be taken.

How can PSC Biotech help streamline the SQ and audit process

PSC Biotech is a leading provider of supplier qualification services. Our team of experts has qualified several suppliers globally. We also provide customized audits depending on the requirements of our clients. We have the experience and expertise to help you select the right supplier and ensure that they meet your quality and regulatory requirements. We understand the challenges of supplier qualification and have developed an efficient and effective processes.

AuditUtopia®, our flagship real-time audit management software hosts regulatory inspections and audits. Life science companies worldwide rely on AuditUtopia to track and manage inspections in real-time. To improve response times to inspection requests, many organizations use AuditUtopia® as the center of their inspection team. AuditUtopia® offers features like configurable reports, single-platform inspection management software, real-time updates, tracking and managing requests, and more. It is a cloud-based system, easily accessible by phone, tablet, or computer, and provides a user-configurable real-time dashboard with multi-site accessibility. AuditUtopia® supports the entire qualification process and other outsourced activities.

The supplier qualification process is important in ensuring that your products meet the highest quality standards. PSC Biotech has the experience and expertise to help you select the right supplier and ensure that they meet your quality and regulatory requirements. Our auditors are multilingual and have 25-40 years of experience with hands-on experience in different fields like pharmaceuticals, medical devices, API, contract manufacturing, etc. In addition, PSC Biotech auditors have experience with multiple regulatory bodies like Food and Drug Administration (FDA), Health Canada, European Medical Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Therapeutic Goods Administration (TGA), National Medical Products Administration (NMPA) and others. The audits are customized based on countries, markets and regulatory targets. At the end of the audit, our clients can expect a comprehensive report about their suppliers.

With PSC Biotech, you don’t have to worry about the supplier qualification auditing process. From the selection of the suppliers through qualification and audits, we do it all. Bonus as we also provide ongoing performance monitoring and oversight. Contact us today to learn more about our supplier qualification services, ACE and AuditUtopia.

 

 

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