Can i know regarding the FR&D sops

Discussion about the sops related to pharmaceutical research and development (R&D).

R & D SOPs should be prepared based on the scope of R & D activities such as number of products to be developed, the type of pharma products to be developed, and test methods. There could be R & D for APIs, Finished dosage forms (Formulations) development, Analytical method development & validation, Process development, etc.

Hi Alex,l

Based on scope of research and development SOP could be prepared. If we say In common they need to prepare routine development process

  1. New product introduction process @ R&D
  2. Procurement of INN & it’s storage , usage & destruction process
  3. Development process for pre formulation, development process.
  4. API & RM procurement process
  5. Innovator/RS/market finish good characterization process
  6. Development stability & product development study process based on product line of action, dosage form, zone wise market requirements.
  7. An individual equipment/machinary operation, cleaning process
  8. Post approval change support procedure
  9. Product transfer process to manufacturing location
  10. Many more