Recent FDA Inspection Supports Offered cGMP Testing Services
CMC Pharmaceuticals recently had its first unannounced Pre-approval/General cGMP Inspection. The inspector concluded on 3-day (Sept. 2023) and observed no objectionable conditions as such no FORM 483 was issued. The center has classified the inspection as “No Action Indicated” and we anticipate receipt of the establishment inspection report shortly. This supports our current cGMP service offerings which include stability studies, release testing, development and validation of analytical methods, and more.
By offering GMP testing services, the data we generate in our laboratories can be used in regulatory filings. Regardless of what stage of development a drug product program is in, facilities that perform GMP testing provide a significant advantage and ensure reliability and credibility. Contract labs like CMC Pharmaceuticals can perform most of the required studies and analytical testing for drug product development programs. It is advantageous to select a lab that is a one-stop-shop and can perform not only early-stage formulation development but also method development and validation, GMP release testing, GMP stability studies, and more. This recent FDA inspection adds additional quality assurance to the type of work performed at CMC Pharmaceuticals.
At this time, CMC Pharmaceuticals cannot manufacture commercial cGMP drug product, but we can provide manufacturing process scale-up services as well as technology transfer services. Oftentimes, commercial manufacturers may not have the capacity to perform early-stage studies or may not have the deep formulation development expertise that CMC Pharmaceuticals can provide. That being said, choosing the right pharma development lab may not only expedite your drug product development program but can also save you money and headaches down the road. We are confident in our ability to support pharma development programs from early stages through commercialization and can even help you choose the right CDMO for manufacturing. Contact us today to learn more!
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