Tag: OQ PQ IQ

Transport Route Qualification: Regulatory Expectations (FDA, WHO)

Transport Route Qualification: Regulatory Expectations (FDA, WHO) Transport Route Qualification: Regulatory Expectations (FDA, WHO) Transport route qualification is a critical component of ensuring the integrity and quality of pharmaceutical products during distribution. This step-by-step tutorial provides a comprehensive framework for…

Role of Material of Construction (MOC) in Primary Packaging Validation

Role of Material of Construction (MOC) in Primary Packaging Validation Role of Material of Construction (MOC) in Primary Packaging Validation The validation of primary packaging components is a critical aspect of pharmaceutical production, ensuring that the materials used do not…

Writing a Site-Specific vs Corporate VMP: What’s the Difference?

Writing a Site-Specific vs Corporate VMP: What’s the Difference? Writing a Site-Specific vs Corporate VMP: What’s the Difference? This comprehensive guide outlines the differences between site-specific and corporate Validation Master Plans (VMP) as part of the validation lifecycle, particularly focusing…

Regulatory Requirements for HVAC Design (FDA, WHO, EMA)

Regulatory Requirements for HVAC Design (FDA, WHO, EMA) Regulatory Requirements for HVAC Design: A Step-by-Step Validation Tutorial In the pharmaceutical and biotechnology industries, an appropriately designed Heating, Ventilation, and Air Conditioning (HVAC) system is critical to maintaining product quality and…

IQ/OQ/PQ Execution Checklist for Commissioning Teams

IQ/OQ/PQ Execution Checklist for Commissioning Teams IQ/OQ/PQ Execution Checklist for Commissioning Teams In the pharmaceutical industry, the validation of manufacturing processes and systems is crucial for ensuring product quality and compliance with regulatory expectations. This comprehensive guide provides a step-by-step…

Risk Assessment Templates for GAMP 5 Validation

Risk Assessment Templates for GAMP 5 Validation Risk Assessment Templates for GAMP 5 Validation In the pharmaceutical and biologics industries, risk assessment forms a critical component of the validation lifecycle, particularly within the context of GAMP 5 guidelines. This tutorial…

Common Mistakes in DQ/IQ/OQ/PQ and How to Avoid Them

Common Mistakes in DQ/IQ/OQ/PQ and How to Avoid Them Common Mistakes in DQ/IQ/OQ/PQ and How to Avoid Them Effective validation of equipment is vital for ensuring compliance with regulatory standards within the pharmaceutical industry. This comprehensive guide provides a detailed,…

Process Design for Complex Dosage Forms: A Practical Guide

Process Design for Complex Dosage Forms: A Practical Guide Process Design for Complex Dosage Forms: A Practical Guide This article serves as a comprehensive guide to the process validation lifecycle, focusing particularly on process design for complex dosage forms. In…

Complete Guide to Process Validation in Pharmaceutical Manufacturing

Complete Guide to Process Validation in Pharmaceutical Manufacturing 1. Introduction to Process Validation Process validation is a critical and mandatory component of pharmaceutical manufacturing. It ensures that a manufacturing process consistently produces products that meet pre-established quality criteria. Defined by…