When patients are administered medications, they trust that the doctor prescribing the drug has confidence in it. A doctor’s faith in a specific drug comes from trusting that the manufacturers used Good Manufacturing Practices (GMP) during clinical trials to ensure the quality and safety of the drug. A GMP certified manufacturer will follow these applications of GMP in clinical trials.
GMP starts with quality control functions. Manufacturers should have a written plan to identify the role of quality control functions in clinical trials, such as the review and approval process for procedures and testing.
Facility and Equipment
The facility and equipment used to manufacture investigational drugs must be a clean environment with adequate space, proper ventilation, and reliable heating or cooling systems. The work area and equipment used should be detailed and documented to determine if they are maintained well enough for clinical trial manufacturing.
Control of Components
Manufacturers should provide written procedures of how to handle all components, closures, and containers in investigational drug manufacturing. All materials should be tested prior to use in manufacturing. Once materials are all deemed appropriate for manufacturing, records of materials should be used to outline all relevant information on the materials, such as how to store them without risk of degradation.
Clinical trial manufacturers should follow a written procedure for manufacturing as well. Manufacturers should keep a record of all materials, procedures, and equipment so they can easily replicate batches of a specific drug. This detailed record should also highlight any problems or changes encountered during the manufacturing process, particularly if a batch was not completed on time.
Laboratory tests such as testing materials should be done in controlled environments, in accordance with written procedures. Testing may be done during quality control manufacturing to define attributes, such as purity and potency of materials being used. Manufacturers should keep a detailed record of these tests. They should also conduct a stability study to monitor the stability and quality of a drug throughout the entire clinical trial. This may include documenting drug data from the initial manufacturing date to the date it was last administered.
Packaging, Labeling, and Distribution
Like many other applications of GMP in clinical trials, manufacturers should follow a written procedure for packaging, labeling, and distribution. This ensures the clinical trial drug is safe from alteration or contamination.
Clinical trial products should be produced following proper GMP to ensure the safety of drugs introduced to human test subjects. GMP provides specific details of the manufacturing process to develop consistent, high-quality investigational drugs for clinical trials.