Tag: process validation

How to Qualify Transport Routes for Pharmaceutical Products

How to Qualify Transport Routes for Pharmaceutical Products How to Qualify Transport Routes for Pharmaceutical Products In the pharmaceutical industry, ensuring that products maintain their quality during transport is critical for patient safety and compliance with regulatory standards. This article…

Validating Vials, Ampoules, and Bottles in Pharma Packaging

Validating Vials, Ampoules, and Bottles in Pharma Packaging Validating Vials, Ampoules, and Bottles in Pharma Packaging Validating the primary packaging components, such as vials, ampoules, and bottles, is a critical aspect of the pharmaceutical manufacturing process. This comprehensive guide focuses…

Designing HVAC Systems for GMP Compliance: A Step-by-Step Guide

Designing HVAC Systems for GMP Compliance: A Step-by-Step Guide Designing HVAC Systems for GMP Compliance: A Step-by-Step Guide Step 1: Understanding User Requirements Specifications (URS) & Risk Assessment Designing HVAC systems for GMP compliance begins with a clear formulation of…

How to Write an Effective IQ Protocol for Pharma Equipment

How to Write an Effective IQ Protocol for Pharma Equipment How to Write an Effective IQ Protocol for Pharma Equipment The validation of pharmaceutical equipment is critical in ensuring product quality, safety, and efficacy. An Installation Qualification (IQ) protocol is…

What to Include in a Validation Master Plan (VMP): Full Breakdown

What to Include in a Validation Master Plan (VMP): Full Breakdown What to Include in a Validation Master Plan (VMP): Full Breakdown In the pharmaceutical industry, a comprehensive Validation Master Plan (VMP) is a crucial component for ensuring compliance and…

GAMP 5 Explained: A Practical Guide for Pharma CSV

GAMP 5 Explained: A Practical Guide for Pharma CSV GAMP 5 Explained: A Practical Guide for Pharma CSV In the complex landscape of pharmaceutical manufacturing, ensuring the reliability and compliance of computer systems is paramount. The GAMP 5 guidelines offer…

Lifecycle Management of Process Robustness Parameters

Lifecycle Management of Process Robustness Parameters Lifecycle Management of Process Robustness Parameters The qualification of equipment in the pharmaceutical industry is a multifaceted process essential for ensuring that manufacturing equipment and systems operate according to defined requirements. This article serves…

Integrating Robustness Assessment into Control Strategy

Integrating Robustness Assessment into Control Strategy Integrating Robustness Assessment into Control Strategy In the pharmaceutical industry, ensuring the quality and consistency of products is paramount. A critical aspect of this is the equipment qualification process, which is foundational for maintaining…

Linking Process Robustness with Continued Process Verification (CPV)

Linking Process Robustness with Continued Process Verification (CPV) Linking Process Robustness with Continued Process Verification (CPV) In the fiercely regulated pharmaceutical and biotechnology industries, ensuring process robustness is crucial to product quality, safety, and efficacy. The journey toward achieving robust…

Case Studies on Process Robustness Across Different Dosage Forms

Case Studies on Process Robustness Across Different Dosage Forms Case Studies on Process Robustness Across Different Dosage Forms Step 1: Defining User Requirements Specification (URS) and Risk Assessment The first step in the validation lifecycle is to define the User…