As we celebrate the 20th anniversary of our Validation Lab in Peenya, Bengaluru, here is a look at the work we do around the world as part of the Validation Lab network.
In today’s pharmaceutical industry ensuring the safety and quality of drug products is of Paramount importance at MK we understand the critical role that a comprehensive validation strategy plays in the development and execution of products manufactured by aseptic filtration the final fill in Downstream operations is a crucial step and the
Sterility Assurance of the final product depends on the validation of the sterilization by filtration process C regulatory bodies across the globe have put in place stringent regulations to safeguard patient safety our validation approach aligns with these guidelines including the recommendations from the United States Food and Drug Administration the European Union W Bic
China Japan and others across the globe we’re here to guide you every step of the way with our Global presence MC is your perfect partner for validation we have state-of-the-art labs in the US Europe China India and Japan each lab serves as a center of excellence for specific validation needs
Ensuring that you receive the highest level of expertise and support our experienced project management team equipped with detailed knowledge of burk’s products and Regulatory expectations will help you assess and manage risks in your filtration process together we will develop a comprehensive and compliant validation strategy that meets your manufacturing
And Market needs quality is at the core of everything we do the validation lab follows ISO certifications and good manufacturing practices with harmonized processes digitalization and robust Quality Management Systems we ensure the highest standards of data integrity and traceability we also prioritize training change control and Sample management as
Integral parts of our quality management system our lab operation team executes over 800 filter validation studies per year working with a wide range of formulations from biologics vaccines small volume parentals to complex injectables we have the expertise to handle your specific requirements we employ Cutting Edge methodologies to validate your aseptic filtration process
Our bacterial retention tests stimulate critical process parameters ensur a robust and compliant challenge through physical and chemical capability testing we ensure that our filters and single use systems do not affect the safety or quality of your drug product our extractables and leachable services provides you with a complete
Understanding of the potential risks and safety evaluation all our labs are compliant with local environment health and safety requirements and sustainability programs our business continuity plan develops prior to and tested during the co pandemic assures uninterrupted service to our customers established more than 4 decades ago our validation Services Labs serve as a
Global leader in the industry showcasing our expertise and commitment to Quality with simplified service selection globally harmonized testing and unparalleled Technical and Regulatory support we offer you an easier way to meet your regulatory requirements trust MK to develop and execute a comprehensive robust and compliant validation strategy for your single use
And aseptic filtration products discover the Merk difference Today