Effective ICH Q8 Pharmaceutical Development Reports


The International Conference on Harmonization (ICH) Common Technical Document (CTD) format is the submission standard for new and abbreviated drug product applications in the United States, the European Union and Japan. One of the significant sections of the CTD is the Pharmaceutical Development Report (PDR). A complete PDR is essential to provide a comprehensive understanding of the product and process for the FDA application reviewers and inspectors. The information in the PDR is based upon the documentation generated during the formulation and process development phase of drug development.

The ICH Q8 and Q8 (R1) Pharmaceutical Development Report guidance documents provide the guidelines for the PDR. As stated in the Q8 guidance, “The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process.” The PDR can, and should, be updated over the lifecycle of the product as new knowledge of the product is obtained.

There are six critical sections to PDR development listed in the Q8 guidance document. Each section addresses a specific component or process in the development process, including:

  • Components of the drug product
  • Information about the drug product formulation development, overages, and physiochemical and biological properties
  • Describes the manufacturing process development
  • Rationale for the choice of the drug product container closure
  • Rationale for selecting the preservative systems and performing, or not performing, the compendial microbial limits and antimicrobial effectiveness tests
  • Compatibility of the drug product with reconstitution diluents or dilution prior to administration for labeling information

Obviously, the primary goal of the marketer and manufacturer of the drug product is to design and produce a product to meet the intended performance. Thus, the PDR should provide sufficient information to describe the formulation and process development and to substantiate that the product is safe and suitable for the intended use.

The Contract Development and Manufacturing Organization (CDMO) is critical to the timely development of the PDR documentation. Furthermore, working with a contract development partner requires close communication and an early understanding of the PDR process by all entities to ensure clear and consistent documentation.