In today’s U.S. drug market, many small to midsize biopharma companies are not fully aware of the applicable regulatory requirements, obligations, and challenges required of them when they want to bring a new biologic or synthetic drug product to market. A company can waste valuable time, money, and resources if certain aspects of Quality are not built into the early phases of the product development and launch processes and if the organization does not follow current Good Manufacturing Practices (cGMPs).
Prior to using drug product in clinical trials, companies that are in early-stage drug development may utilize analytical testing with equipment that is not considered validated, produce testing documentation that may not be reviewed by quality personnel, and use analytical testing methods that are also not considered validated. Additionally, the drug material itself may be made from active and excipient materials that are only accepted on the manufacturer’s certificate of analysis.
This approach to “fine tuning” the drug product itself to produce desired results is acceptable in the early development stages, but companies must ensure their product is safe and effective before entering it into clinical trials. To do this, they must implement a state of control by instituting critical process parameters (CPPs). As products are introduced into Phase I clinical trials, GMP controls must be implemented.
Companies then have the goal of finding sufficient success in clinical trials to file for their Investigational New Drug Application (IND), New Drug Application (NDA), or Biologic License Application (BLA).
While full GMP compliance may not be mandatory at the very early stages of product development, establishing foundational quality practices and a basic Quality Management System (QMS) can be very beneficial.
Initially, this can be done at minimal cost by having a knowledgeable Quality GMP consultant perform a gap assessment. This assessment will help to determine how far along the company is with basic GMP procedures and identify what the current commercial strategy is to “right size” the QMS. For example, when establishing a commercial strategy, the company might consider whether it intends to manufacture the commercial product itself or whether this will be outsourced to a Contract Drug Manufacturing Organization (CDMO). Another consideration is who will be supplying drug materials and services such as laboratory testing.
Once the gap assessment is completed, a detailed report will be provided. This report can be used as a strategy document to identify what documents, procedures, policies, etc., need to be drafted and implemented. It will also identify company personnel with the necessary knowledge and experience to be considered the firm’s head of Quality or make recommendations to operate in an interim fashion until this position can be appointed.
Coinciding with the gap assessment report the base of the QMS system is established by generating drafting procedures beginning with a Quality Manual that defines the organization’s quality management system and demonstrates how the quality management system should function. From here, basic procedures can be built to suit the design outlined in the Quality Manual. 
