PURELAB® Pharma Compliance provides ultrapure water for pharmaceutical quality control laboratories to meet Good Manufacturing Practices (GMP) requirements.
Overview
Having been designed exclusively for industry professionals from pharmaceutical and laboratory quality control, PURELAB Pharma Compliance uses advanced purification processes — exceeding industry standards — to provide ultrapure water, an essential component for pharmaceutical quality control labs.
Designed with ALCOA+ in mind — guidance regarding data integrity in life science: Attributable, Legible, Contemporaneous, Original, and Accurate — the secure software ensures data integrity and traceability, meeting the stringent requirements of both the U.S. Food and Drug Administration (FDA) and EU standards. Additionally, this compliance-ready system gives your laboratory the confidence it needs during audits and inspections.
Features and benefits
Secure software meets FDA (FDA 21 CFR Part 11) and EU (EUDRALEX Annex 11) standards for digital record keeping.
Complies with the United States Pharmacopeia standards 643 and 645, guaranteeing optimum water quality for validating drug purity.
Modular and compact to optimize laboratory space.
Well-designed consumables reduce costs and environmental waste.
Adherence to GMP validation standards.
Relay on our expert service teams around the world.
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We are committed to providing pharmaceutical industry professionals with the tools they need to achieve excellence in their quality control processes. We are proud to contribute to the advancement of pharmaceutical research and manufacturing while maintaining the highest standards of regulatory compliance. PURELAB Pharma Compliance represents a quantum leap in the world of pharmaceutical laboratory water solutions.
Fabien Ancenay
Scientific and Healthcare Sales Manager, Elga LabWater
Contact Fabien through his LinkedIn account
ELGA offers an outstanding user experience. Quality, simplicity and reliability build trust and ensure quality control teams are at their most effective. PURELAB Pharma Compliance is GMP and quality control ready and is supported by an unmatched global service and validation team.
David Grant
Global Product Manager, Elga
Contact David through his LinkedIn account
FAQ about PURELAB® Pharma Compliance
Why is purified water essential for quality control laboratories in the pharmaceutical industry?
Purified water is the foundation of accurate and reliable pharmaceutical quality control processes in pharmaceutical laboratories. It ensures that test results are not compromised by impurities or contaminants, which is critical for maintaining product quality and safety.
How does the quality of water impact pharmaceutical quality control tests?
The quality of water used in pharmaceutical laboratories directly affects the precision and accuracy of pharmaceutical quality control tests. Impure water can introduce variables that lead to inaccurate results, higher running costs, potentially impacting the safety and efficacy of pharmaceutical products.
What role does water purification technology play in ensuring water quality for quality control labs?
Water purification technology removes impurities and contaminants from water, ensuring it meets the stringent requirements of pharmaceutical quality control . These technologies are essential for maintaining water quality and, in turn, product quality.
How can pharmaceutical laboratories ensure a consistent supply of high-quality purified water for their quality control processes?
Pharmaceutical laboratories invest in state-of-the-art water purification systems and establish robust monitoring and maintenance protocols to ensure a continuous and reliable supply of purified water for pharmaceutical quality control testing.
Case Study
Our experts set up a purified water and ultrapure water production station for a Belgian manufacturer of ophthalmic devices. To meet the customer’s ultrapure water needs, PURELAB Pharma Compliance was chosen owing to surpassing FDA requirements. It gives the manufacturer peace of mind knowing its water quality is being closely monitored to ensure compliance.
