Regulatory Odd Couple Series

July 23, 2020

The Odd Couple – Part 5: Authoring the Container Closure Systems for Packaging of Drug Substance and Product Modules

Container closure systems refer to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. The packaging information in the chemistry, manufacturing, and controls section usually includes a description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance and drug product during their use.
August 4, 2020

The Odd Couple – Part 6: Authoring the Stability of Drug Substance and Product Modules

Stability testing is an important part of the drug development and approval process, determining the safety and integrity of the drug and also its shelf life and storage conditions.
August 13, 2020

The Odd Couple – Part 7: Authoring the Composition and Pharmaceutical Development Modules

Pharmaceuticals (both Synthetically and Biotechnology-derived) are being developed by many sponsors whose management teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products.