Drug Substance & CMC Development Tool Box: Selection of cGMP Starting Materials (RSMs)

cGMP Starting Materials (Regulatory or Registered Starting Materials, ‘RSMs’) represent the formal start of cGMP (current Good Manufacturing Practice) control, and potential start of validation for a given Drug Substance/Active Pharmaceutical Ingredient (API) manufacturing process.

This highlight article outlines main selection factors described in ICH Q11 and Q&A guides, and presents several examples of their application.   

Key selection factors include:

  • Placement in the overall synthesis, including separation from common reagents and from the Drug Substance
  • Material characterization, analytical and stability knowledge
  • Impurity profile and management, in particular of high risk impurities (e.g. DNA-reactive impurities or nitrosamines)
  • Specification tests and criteria, and contribution to overall control strategy
  • Source selection and manufacturing controls, including knowledge and management of process and process changes

Download the Document

    * denotes a required field
    Please fill out the information below to request information for the products you selected. If you are already registered, or have requested a quote before, and this information will be filled out for you.
  • Please enter your first and last name.

  • Please enter the name of the company or institution you work at.

  • Please enter your mailing address.

  • Please enter the phone number you would like to be contacted at.

  • Please enter the e-mail address you would like to be contacted at.