Module 3

Regulatory Requirements for a New Chemical Active Substance: Chemistry and Pharmacy

Aim

The purpose of this Module is to provide students with an understanding of the chemistry and pharmacy development programme to enable them to provide effective advice on the suitability of the chemistry and pharmacy programmes from a regulatory perspective.

Learning outcomes

  • Students will identify the drug substance requirements: nomenclature, description, synthesis, development chemistry, quality control during synthesis, stability.
  • Students will define the drug product requirements: formulation and pharmaceutical development, dissolution testing, bioequivalence of different dosage forms used in clinical trials, manufacture, GMP, process validation, specifications and routine tests, analytical method development, packaging and stability.
  • Students will recognise the importance of analytical validation.
  • Students will discriminate between the chemical and pharmaceutical aspects of clinical trial and marketing authorisation applications.
  • Students will define the formatting of the chemistry and pharmacy documentation as per the requirements of the Common Technical Document.
  • Students will understand the Regulatory Authorities’ views of the chemistry and pharmacy dossier.

Outline of Module topics

  • The role of chemistry and pharmacy in the overall drug development programme.
  • The chemistry and pharmacy dossier: format and structure in the EU and US. Module 3 of the Common Technical Document.
  • Drug Master Files and Certificates of Suitability.
  • Nomenclature and characterisation of drug substances.
  • Analytical methods and validation.
  • Manufacture and in-process controls of drug substances.
  • Pharmaceutical development and manufacture of the drug product.
  • Relevance of bioequivalence and bioavailablity in formulation development.
  • Quality control during the manufacture of the dosage form.
  • Development of specifications for the drug substance and drug product.
  • Stability requirements of drug substances and drug products.
  • Chemistry and pharmacy section of clinical trials applications (IMPD/IND).
  • Good Manufacturing Practice and its applications to the drug substance and drug product. Risk management.
  • The role of the Qualified Person.
  • Pharmaceutical Expert Reports versus the Quality Overall Summary and their relationship to the Common Technical Document.
  • Packaging requirements of drug substances and drug product products.
  • Environmental impact assessment.
  • View of the Regulatory Authorities: common deficiencies and major concerns.

Links with other Modules

  • Module 2 covers preclinical aspects of the regulatory strategy for a new active substance.
  • Module 8 covers data requirements for abridged applications and specialist products.
  • Module 11 covers specific requirements for New Drug Applications in the US.