The independent quality unit should have adequate laboratory facilities. Documented procedures should cover sampling and testing, the decision to approve or reject materials, and how laboratory data are recorded and stored, with records kept as in section 6.6. Specifications, sampling plans and test methods should rest on sound science, consistent with the registration or filing (additional ones may exist), drafted by the responsible unit, then reviewed and signed off by the quality unit, including changes. API specifications should follow accepted standards, fit the process and control organic and inorganic impurities and residual solvents, with action limits for microbial counts, objectionable organisms and endotoxins where those are specified. Laboratory controls should be carried out as written and recorded when performed, departures explained. Every out-of-specification result should be investigated and documented under a procedure requiring data analysis, a judgement on whether there is a significant problem, assignment of corrective actions and conclusions, with resampling and retesting done under a documented procedure. Reagents and standard solutions should be made up and labelled by written procedure with use-by dates. Primary reference standards should be sourced as needed, their source documented and storage and use recorded; where no official source exists, the firm should set up its own primary standard, fully characterised for identity and purity. Secondary standards should be prepared, identified, tested, approved and stored, checked against a primary before first use and periodically requalified under a written protocol.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.