Tag: pq iq oq

Choosing Qualified Distribution Partners for Sensitive Products

Choosing Qualified Distribution Partners for Sensitive Products Choosing Qualified Distribution Partners for Sensitive Products In the pharmaceutical industry, the safe and effective transportation of sensitive products is critical. Ensuring that distribution partners meet the requirements for process validation, particularly through…

Compatibility Studies Between Drug Product and Packaging Material

Compatibility Studies Between Drug Product and Packaging Material Compatibility Studies Between Drug Product and Packaging Material The compatibility between drug products and their packaging materials is critical to ensuring that the drug remains effective, safe, and of high quality throughout…

Planning HVAC for API Manufacturing Facilities

Planning HVAC for API Manufacturing Facilities Planning HVAC for API Manufacturing Facilities Environmental control is paramount in Active Pharmaceutical Ingredient (API) manufacturing. The Heating, Ventilation, and Air Conditioning (HVAC) system plays a crucial role in ensuring that the facility meets…

Review and Approval Workflow for Qualification Protocols

Review and Approval Workflow for Qualification Protocols Review and Approval Workflow for Qualification Protocols This article provides a comprehensive step-by-step guide on the review and approval workflow for qualification protocols in the pharmaceutical industry, focusing on Installation Qualification (IQ), Operational…

VMP Approval Workflow and Change Control Process

VMP Approval Workflow and Change Control Process VMP Approval Workflow and Change Control Process This article provides a comprehensive step-by-step guide on the VMP approval workflow and change control process, specifically focusing on the stages of process validation including pq…

Applying the V-Model in CSV Projects: Examples and Templates

Applying the V-Model in CSV Projects: Examples and Templates Applying the V-Model in CSV Projects: Examples and Templates In the constantly evolving landscape of the pharmaceutical industry, ensuring compliance with validation standards is crucial. The V-Model is a robust framework…

Performance Qualification (PQ) for Pharma Equipment: A Full Guide

Performance Qualification (PQ) for Pharma Equipment: A Full Guide Performance Qualification (PQ) for Pharma Equipment: A Full Guide Performance Qualification (PQ) is a critical step in the overall equipment qualification process within the pharmaceutical industry, ensuring that systems and processes…

Establishing Control Strategy During Initial Process Design

Establishing Control Strategy During Initial Process Design Establishing Control Strategy During Initial Process Design In the pharmaceutical industry, the validation lifecycle is a critical process to ensure that products are consistently produced to meet quality standards. Successful validation involves a…