Licensed Biological Therapeutic Drug



Manufacturers who purchase components from outside sources are required to establish adequate quality requirements and specifications for such components. The licensed manufacturer is ultimately responsible for ensuring that components conform to specifications and are acceptable for use. Read More


Therapeutic products are manufactured in a controlled environment. The entire process does not have to be done under aseptic conditions, but the company must have established the point in the process where aseptic controls begin. Read More


Validation data for the manufacturing process are generally reviewed during application review, as are the validation data to support changes that are reported in prior approval supplements. Read More

Testing and Laboratory Controls

A large component of every GMP inspection is the inspection of the laboratory. Laboratory equipment and procedures must be qualified and validated. Required testing is defined in the regulations and in the approved license application. Read More

Environmental Controls and Monitoring

There should be a comprehensive environmental monitoring program, which includes monitoring for nonviable and viable air particulates, surface viables and, in the aseptic filling areas, personnel. Read More

Cross Contamination

Cross-contamination may be a significant concern in a facility that manufactures more than one product. The company's method for separating the products, either by space or time, should be reviewed to ensure that there is no potential for cross-contamination. Read More

Nonconforming Product

FDA investigators will determine if the manufacturer has established and implemented procedures for control of nonconforming product that include a determination of the need for an investigation, and a written evaluation of the investigation, if conducted. Read More


Ensure that key equipment and procedures (those that could affect product quality, e.g., autoclaves, heat treatment baths, filling equipment and product contact surfaces, filling and closing of containers, lyophilizers, depyrogenation equipment) used by the company are suitable for their intended uses. Read More


Records required by the cGMP regulations must be maintained at the manufacturing facility or at another location reasonably accessible to responsible officials of the manufacturer and to FDA investigators. Read More


CDER may request sample collection and will provide specific instructions to investigators. Read More