API Synthesis: Validation
In a regulated industry, special care must be taken to ensure all equipment and processes are performing to specifications. Deviations can have unpredictable and sometimes devastating results. Therefore, we pay special attention to equipment qualification and process validation to provide full regulatory compliance for our API manufacturing clients. We follow the strictest guidelines, perform the most rigorous testing and execute studies in a timely fashion to ensure that your product is of the highest quality when it reaches its destination.
Dalton has capabilities to develop, create and execute validation protocols and studies required for your products and equipment in accordance with current Guidelines (HPFBI, FDA, EP, ICH, WHO) and acceptable formats (prospective, retrospective and concurrent). These include process validation, cleaning validation, aseptic processing, terminal sterilization, environmental control, IQ/OQ/PQ/PV and utility qualifications. Statistical analysis and decision making analysis are also part of our service.
We stand by our products, which are manufactured to the highest quality standards. Learn more about our Custom Drug Synthesis products.
If what you are looking for is not on the list please contact us at 1-800-567-5060 or 416-661-2102 or email us and we will gladly meet your pharmaceutical contract manufacturing needs.