Tag: Vendor Qualification Process

On-Site vs Remote Vendor Audits: Pros, Cons, and Requirements

On-Site vs Remote Vendor Audits: Pros, Cons, and Requirements On-Site vs Remote Vendor Audits: Pros, Cons, and Requirements The vendor audit process is a critical component of the pharmaceutical industry’s quality assurance and compliance strategy. With the evolving landscape of…

Risk-Based Approach to Vendor Qualification

Risk-Based Approach to Vendor Qualification Risk-Based Approach to Vendor Qualification In the pharmaceutical and medical device industries, the qualification of vendors and materials is a critical component that ensures product quality and compliance with regulatory requirements. The FDA, EMA, and…

What to Include in a Vendor Qualification Questionnaire

What to Include in a Vendor Qualification Questionnaire What to Include in a Vendor Qualification Questionnaire The qualification of equipment in the pharma industry is a critical component of ensuring compliance with regulatory standards and maintaining product quality. A systematic…

Vendor Qualification SOP: Format, Flowchart, and Best Practices

Vendor Qualification SOP: Format, Flowchart, and Best Practices Vendor Qualification SOP: Format, Flowchart, and Best Practices Step 1: Understanding the User Requirement Specification (URS) and Risk Assessment The initial stage of the equipment qualification process in pharma involves preparing a…

Step-by-Step Guide to Supplier Audits for GMP Compliance

Step-by-Step Guide to Supplier Audits for GMP Compliance Step-by-Step Guide to Supplier Audits for GMP Compliance This detailed guide provides pharmaceutical professionals with a comprehensive roadmap for the qualification of equipment in the pharma industry. Containing a step-by-step validation tutorial,…

How to Qualify a New Vendor in the Pharma Industry

How to Qualify a New Vendor in the Pharma Industry How to Qualify a New Vendor in the Pharma Industry Qualifying a new vendor in the pharmaceutical industry is crucial to ensuring that all equipment and materials meet regulatory standards.…