Summary
Macrocyclics has implemented a quality system for manufacturing and testing of non-sterile active pharmaceutical ingredients (APIs) for research purposes only (including clinical trials). Macrocyclics cGMP products are not intended for use as approved drug products but rather serve as one component of a more complex drug product. None of our current products are purported to be sterile.
Over the past six months Macrocyclics has made a strong push towards developing cGMP manufacturing/testing at our facility. After an analysis of our products and their uses in the industry, an appropriate cGMP quality system was created and implemented. The main guidance was provided by FDA guidance document Q7A Section 19, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients - APIs for use in Clinical Trials.
Audits
Macrocyclics welcomes customers to schedule a formal audit of our cGMP quality system prior to the purchase of a cGMP product. Requests must be made at least one week in advance.
More Information
For more information on Macrocyclics' cGMP quality system, please contact our Quality Manager, Paul Jurek or fill out the request form below.
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