Pharmaceutical Equipment Qualification: eyetec's approach to IQ OQ PQ
Installation Qualification (IQ)
The equipment qualification process starts with Installation Qualification, a critical step that entails a thorough verification to ensure each piece of equipment has been correctly installed. This phase involves a meticulous review of various types of GMP equipment. The objective is to confirm that these installations comply with predefined configurations and are correctly set up according to both the manufacturer's specifications and regulatory standards. Detailed documentation during this phase provides a robust evidence trail to validate the accuracy of the installation.
Operational Qualification Testing
After installation, the Operational Qualification phase tests each machine's functionality under typical operating conditions. This critical evaluation confirms that all equipment operates reliably and is capable of producing the desired outcomes, which is vital for maintaining high standards of product quality and safety.
Performance Qualification
The final phase, Performance Qualification, assesses the equipment in actual production settings to verify that it not only performs under ideal test conditions but also functions effectively and reliably under real-world operational conditions.
Customized solutions for diverse manufacturing needs
Recognizing the diversity in pharmaceutical manufacturing needs, a flexible approach is essential. Whether integrating multiple steps for simpler machines or applying distinct qualifications for more complex systems, tailoring the qualification process is key to covering all aspects of equipment validation comprehensively.
The benefits of a structured approach to equipment qualification
Engaging with a knowledgeable team in pharmaceutical manufacturing can significantly enhance operational efficiency. This engagement provides:
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Expert equipment knowledge: eyetec offers detailed insights into sophisticated equipment, ensuring optimal functionality and reliability that meet rigorous industry specifications.
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Technical problem solving: quick diagnosis and resolve of technical issues help maintain smooth and uninterrupted operations.
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In-house calibration: maintaining high standards of precision and reliability, in-house calibration simplifies operational processes.
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Deep compliance knowledge: a thorough knowledge of regulations ensures that all phases of equipment qualification meet GMP standards so that operations are ready for any audits.
"Adhering to IQ, OQ, and PQ processes is essential for any pharmaceutical manufacturer looking to ensure that their equipment meets rigorous international standards. Understanding these processes helps in maintaining the highest levels of product quality and safety." - Menno Sels, Process Engineer pharma equipment eyetec
Ready to ensure your equipment meets the highest standards? Contact our experts today.
