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.
Based on scope of research and development SOP could be prepared. If we say In common they need to prepare routine development process
- New product introduction process @ R&D
- Procurement of INN & it’s storage , usage & destruction process
- Development process for pre formulation, development process.
- API & RM procurement process
- Innovator/RS/market finish good characterization process
- Development stability & product development study process based on product line of action, dosage form, zone wise market requirements.
- An individual equipment/machinary operation, cleaning process
- Post approval change support procedure
- Product transfer process to manufacturing location
- Many more
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