Victoria Andujar

Nov 29, 2024 | ellab.com | Victoria Andujar

Blog Validation Transforming the I... Validation As we approach 2025, pharmaceutical validation is undergoing a transformation, with companies leveraging innovative technologies and methods to ensure product quality and safety. The appearance of more refined validation approaches – from continuous process verification to comprehensive digital solutions – marks a pivotal shift from traditional validation methods.

Oct 9, 2024 | ellab.com | Victoria Andujar

What is process validationThis type of validation is used to confirm that a manufacturing operation consistently produces products that meet defined quality standards. This process collects and evaluates data from the process design stage throughout production. Process validation helps identify potential risks, monitor critical control points, and mitigate any variations that could affect the final product’s quality.

Sep 18, 2024 | ellab.com | Victoria Andujar

Blog Compliance Common Compliance ... Compliance Compliance issues in pharma are common, especially during audits: understanding and adhering to GxP compliance requirements is essential for avoiding these issues and maintaining operational integrity.

Aug 26, 2024 | ellab.com | Thomas Flanagan |Victoria Andujar |Laura Hatchard

Environmental monitoring is crucial for product safety, and the well-being of staff and patients. Uncontrolled contaminants, temperature fluctuations, and humidity can compromise the quality and efficacy of life-saving treatments, which can have severe consequences. Additionally, environmental monitoring helps maintain safe working conditions for staff, reducing the risk of accidents and exposure to harmful substances.

Aug 8, 2024 | ellab.com | Nathan Roman |Victoria Andujar |Zoe Hall |Laura Hatchard

Blog Validation How to Qualify an ... Validation Incubator qualification is a critical process in ensuring that these essential pieces of laboratory equipment are properly installed, operate within specified parameters, and meet both manufacturer and user requirements. This verification process ensures compliance with regulatory standards, protects sample integrity, and maintains accurate experimental conditions.