Can i know regarding the FR&D sops

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

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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.

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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
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