Documents on making APIs or intermediates should be drafted, reviewed, approved and issued under written procedures, on paper or electronically, and their issue, revision, replacement and withdrawal should be controlled with revision histories kept. A procedure should set retention for all relevant documents (development, scale-up, technology transfer and validation reports, training, production, control and distribution records) with stated periods. Production, control and distribution records should then be retained for at least one year after batch expiry, or for APIs with retest dates at least three years after the batch is fully distributed. Entries should be made indelibly in the spaces provided, straight after the activity, identifying who made them; corrections should be dated, signed and leave the original legible. During retention, records should be readily available where the activity happened (or promptly retrievable electronically). Originals or true copies such as microfilm or electronic records may be kept, with means to retrieve and print them. Specifications should be set for raw materials, intermediates where needed, APIs, labelling and packaging materials and other materials that could critically affect quality, and acceptance criteria for in-process controls documented. Electronic signatures should be authenticated and secure.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.