What Will Practical Knowledge of Industry Operations and QA Buy You?
The Practical Solutions Group, LLC was retained by a Canadian company to perform an audit of an Active Pharmaceutical Ingredient (API) manufacturer located in Mexico. Our client did not send any of its own representatives and left it up to us to ensure that the API manufacturer is compliant with appropriate regulations, has the required capacity to scale-up and is able to resolve the technical challenges associated with meeting client-specific particle-size specifications. Without any further input from the client, we quickly and correctly determined that the reliability of the continuous supply of the high-quality API was one of the most critical issues to assess during the visit.
All of the site documentation (e.g., SOPs, batch records, laboratory notebooks, logs) was in Spanish. Nonetheless, in only a two (2) day site visit, through focusing on the areas of the highest risk, we identified a number of regulatory deficiencies pertaining to SOPs, manufacturing and laboratory operations. At the same time, we collected quite a bit of information regarding serious logistics-related and technical issues.
Our client found our recommendations that pertained to a long-term availability of the API material to be the most valuable because, given the unusual and difficult-to-work-with nature of the API, there is only a handful of companies in the world that our client can choose from. Recognizing that “time is money” for any company that is planning to submit an NDA, we provided our client with the final 34-page report within five (5) business days after completing the site visit. The report included a comprehensive summary of the vendor’s operations, regulatory compliance observations and a list of business suggestions. Timeliness, accuracy and practicality – that’s what practical knowledge of the industry operations and QA will buy you with The Practical Solutions Group, LLC.