Tag: iso 11135

Mapping Temperature Fluctuations in Logistics Supply Chains

Mapping Temperature Fluctuations in Logistics Supply Chains Mapping Temperature Fluctuations in Logistics Supply Chains Mapping temperature fluctuations in logistics supply chains is critical in ensuring the integrity and quality of pharmaceutical products during transport. This comprehensive guide presents a step-by-step…

Transport Route Risk Assessment: Tools, Templates & Examples

Transport Route Risk Assessment: Tools, Templates & Examples Transport Route Risk Assessment: Tools, Templates & Examples In the context of pharmaceutical manufacturing and distribution, transport route risk assessment is pivotal for ensuring product integrity. This comprehensive guide covers the step-by-step…

How to Perform Dimensional Testing of Primary Packaging Components

How to Perform Dimensional Testing of Primary Packaging Components How to Perform Dimensional Testing of Primary Packaging Components Dimensional testing of primary packaging components is critical in ensuring compliance with regulatory standards such as ISO 11135, ISO 14644, and ISO…

Container-Closure Integrity (CCI) Testing: Methods & Acceptance Criteria

Container-Closure Integrity (CCI) Testing: Methods & Acceptance Criteria Container-Closure Integrity (CCI) Testing: Methods & Acceptance Criteria Container-Closure Integrity (CCI) testing is a critical component in ensuring the safety and efficacy of pharmaceutical products. This article provides a comprehensive, step-by-step validation…

Cleanroom Design: HVAC Zoning, Pressure Cascade, and Airflow

Cleanroom Design: HVAC Zoning, Pressure Cascade, and Airflow Cleanroom Design: HVAC Zoning, Pressure Cascade, and Airflow In pharmaceutical manufacturing, maintaining a controlled environment is crucial for product quality and compliance with regulatory standards. The validation of HVAC systems in cleanrooms…

Room Classification Standards for Pharma HVAC Systems (ISO 14644, EU GMP)

Room Classification Standards for Pharma HVAC Systems (ISO 14644, EU GMP) Room Classification Standards for Pharma HVAC Systems (ISO 14644, EU GMP) In the pharmaceutical industry, maintaining controlled environments is essential for ensuring product quality and compliance with regulatory requirements.…

What Is a Design Qualification (DQ) and When Is It Required?

What Is a Design Qualification (DQ) and When Is It Required? What Is a Design Qualification (DQ) and When Is It Required? In the pharmaceutical and biologics sectors, ensuring product quality and regulatory compliance is paramount. One of the critical…

Operational Qualification (OQ) Templates: What to Include and Why

Operational Qualification (OQ) Templates: What to Include and Why Operational Qualification (OQ) Templates: What to Include and Why The Operational Qualification (OQ) phase is essential in the validation lifecycle for pharmaceutical and biologics processes. This phase ensures that equipment and…

Writing the Scope and Objectives Section of a VMP

Writing the Scope and Objectives Section of a VMP Writing the Scope and Objectives Section of a VMP In the highly regulated pharmaceutical environment, the Validation Master Plan (VMP) serves as a foundational document that outlines the strategies, protocols, and…

Sample VMP Table of Contents for Pharma and Biotech

Sample VMP Table of Contents for Pharma and Biotech Sample VMP Table of Contents for Pharma and Biotech Step 1: Understanding Validation Master Plan (VMP) Objectives The Validation Master Plan (VMP) serves as a comprehensive roadmap detailing how a pharmaceutical…