Tag: Qualification of Vendors & Materials

Establishing Specifications for Incoming Raw Materials

Establishing Specifications for Incoming Raw Materials Establishing Specifications for Incoming Raw Materials Establishing specifications for incoming raw materials is a critical component of the pharmaceutical quality system. It ensures that all materials meet predefined standards before they are used in…

Vendor COA Verification During Raw Material Qualification

Vendor COA Verification During Raw Material Qualification Vendor COA Verification During Raw Material Qualification In the pharmaceutical industry, ensuring the quality of raw materials is of utmost importance. One essential aspect of this process is the verification of the Certificate…

Analytical Testing Requirements for Raw Material Approval

Analytical Testing Requirements for Raw Material Approval Analytical Testing Requirements for Raw Material Approval This article serves as a comprehensive guide for pharmaceutical professionals involved in the qualification of raw materials. It emphasizes the critical role of gmp verification processes…

Raw Material Qualification in Pharma: Full Lifecycle Approach

Raw Material Qualification in Pharma: Full Lifecycle Approach Raw Material Qualification in Pharma: Full Lifecycle Approach The qualification of raw materials is a critical aspect of pharmaceutical manufacturing that ensures the integrity, safety, and efficacy of drug products. In this…

Requalification of Vendors: Frequency, Triggers, and Documentation

Requalification of Vendors: Frequency, Triggers, and Documentation Requalification of Vendors: Frequency, Triggers, and Documentation In the highly regulated environment of pharmaceutical manufacturing, vendor qualification is a critical process that ensures the integrity and compliance of materials and services used in…

Regulatory Expectations for Supplier Qualification (FDA, EMA, WHO)

Regulatory Expectations for Supplier Qualification (FDA, EMA, WHO) Regulatory Expectations for Supplier Qualification (FDA, EMA, WHO) 1. Understanding User Requirements Specification (URS) & Risk Assessment The first step in the filter validation lifecycle involves the development of a User Requirements…

Supplier Qualification File Checklist for Audit Readiness

Supplier Qualification File Checklist for Audit Readiness Supplier Qualification File Checklist for Audit Readiness In the pharmaceutical industry, where the stakes of product quality and patient safety are extraordinarily high, having a robust vendor qualification process is essential. The Supplier…

Linking Vendor Qualification to Product Release and QA

Linking Vendor Qualification to Product Release and QA Linking Vendor Qualification to Product Release and QA The pharmaceutical industry faces increasing regulations and expectations regarding validation processes. A robust vendor qualification process plays a crucial role in ensuring that materials…

Common Audit Findings During Vendor Qualification

Common Audit Findings During Vendor Qualification Common Audit Findings During Vendor Qualification Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first critical step in vendor qualification is developing a comprehensive User Requirements Specification (URS). A URS outlines…

How to Perform a Gap Assessment for Vendor Systems

How to Perform a Gap Assessment for Vendor Systems How to Perform a Gap Assessment for Vendor Systems Step 1: Understand Regulatory Requirements and Guidelines Before embarking on a gap assessment for vendor systems, it is crucial to understand the…