Tag: iq and oq

Updating Route Qualification After Lane or Vendor Changes

Updating Route Qualification After Lane or Vendor Changes Updating Route Qualification After Lane or Vendor Changes The transportation of pharmaceutical products necessitates stringent adherence to quality assurance protocols, especially during route qualification updates after changes to lanes or vendors. This…

Change Control and Revalidation for Primary Packaging Components

Change Control and Revalidation for Primary Packaging Components Change Control and Revalidation for Primary Packaging Components In the pharmaceutical industry, the validation of packaging systems is critical to ensure product quality and compliance with regulatory requirements. This article is a…

Risk-Based Approach to HVAC Design for New Facilities

Risk-Based Approach to HVAC Design for New Facilities Risk-Based Approach to HVAC Design for New Facilities In the pharmaceutical and biologics industries, maintaining a controlled environment is paramount for compliance with regulatory standards and for ensuring product quality. The HVAC…

Using GAMP 5 in IQ/OQ/PQ Documentation

Using GAMP 5 in IQ/OQ/PQ Documentation Using GAMP 5 in IQ/OQ/PQ Documentation In the pharmaceutical industry, the principles of validation are critical for ensuring product quality and compliance with regulatory standards. The integration of GAMP 5 (Good Automated Manufacturing Practice)…

How to Align VMP Structure With Lifecycle Validation Principles

How to Align VMP Structure With Lifecycle Validation Principles How to Align VMP Structure With Lifecycle Validation Principles Validation Master Plans (VMP) serve as a comprehensive outline of the validation strategy throughout the lifecycle of pharmaceutical products. In this article,…

Role of IT and QA in GAMP 5-Based System Validation

Role of IT and QA in GAMP 5-Based System Validation Role of IT and QA in GAMP 5-Based System Validation In the pharmaceutical industry, validation of computer systems is critical to ensure compliance with regulatory requirements and to maintain quality…

Regulatory Expectations for IQOQPQ in FDA and EU Audits

Regulatory Expectations for IQOQPQ in FDA and EU Audits Regulatory Expectations for IQOQPQ in FDA and EU Audits In the pharmaceutical industry, ensuring that equipment and processes meet defined standards is critical for compliance with Good Manufacturing Practices (GMP). The…

Design Input Requirements for Stage 1 Process Development

Design Input Requirements for Stage 1 Process Development Design Input Requirements for Stage 1 Process Development 1. Understanding User Requirements Specification (URS) and Risk Assessment The first step in Stage 1 of the validation lifecycle is the formulation of the…