Responsible for identifying the need for updation and filling out the initial form.
Compare the current "as-is" process on the shop floor with the "to-be" written procedure. Identify exactly where the instructions fail to meet reality. 2. Stakeholder Collaboration Don't write in a vacuum. Consult with: Subject Matter Experts (SMEs): The people actually doing the work. QA/QC Teams: To ensure compliance with GMP standards 3. Draft & Review pharma devils sop upd