Manufacturer Management Program

Streamline API Sourcing with LGM Pharma’s Pre-Qualified Manufacturers

API Manufacturer Management: Let LGM do the work for you

The global manufacturer market for active pharmaceutical ingredients (APIs) is vast, and conducting the due diligence required to separate high quality from the rest is increasingly expensive and time intensive. Leave the work to the API sourcing and quality specialists at LGM Pharma. We work as your partner to connect you with the right API manufacturer from our prequalified, globally distributed manufacturer network and act as your advocate for the length of your project.  Our rigorous qualification process ensures API manufacturing companies are compliant from the first day we work with them and into the future.

How We Manage API Manufacturers

Our vendor management program includes careful due diligence in which we select only the top quality, reputable pharmaceutical manufacturers for your supply. We routinely perform regulatory checks and maintain qualification and regulatory documents on file for each material we obtain from our API manufacturers.

As a part of the initial screening check, our sourcing team examines the manufacturer’s expertise, years in business, reputation, and cost efficiency. Once an API manufacturer passes this initial screening, the LGM quality team conducts deeper and ongoing due diligence such as evaluation of GMP compliant facilities, equipment, and regulatory, as well as, quality systems.

Questions We Ask

  • Is the supplier cGMP compliant?
  • What quality procedures and systems are in place?
  • Has the supplier received any warning letters, import alerts, recalls, or other regulatory issues from agencies such as the FDA?
  • Does the supplier have a DMF for the API or have approved DMFs for other regulatory submissions that can support a DMF for the API in question?
  • What procedures are in place to handle customer complaints, deviations, investigations, change control, training, batch record review, and CAPAs?
  • What data integrity procedures are in place for compliance with CFR Part 11 for ALCOA+?
  • Can they scale the supply of API as the project moves through the development lifecycle to commercialization? What’s the average capacity utilization, spare capacity, and any future expansion plans?
  • Can we establish a quality agreement that describes the roles and responsibilities of supplier, distributor, and customers?

LGM Pharma has a network of 300+ prequalified GMP-compliant API manufacturers with a distributed geographic profile across the the Americas, Europe, and Asia.