Pharmaceuticals, approval procedure origin

PET, see Polyethylene terephthalate Petit, Rowland, 524 Petroleum, catalytic cracking of, 100 composition of, 99-100 gasoline from. 99-100 history of, 99 refining of, 99-100 Pharmaceuticals, approval procedure for, 165 origin of, 164 Phenol(s), 599... 

Documentation will typically comprise validation life-cycle documents and procedures, SOPs, training records, quality records and procedures, process and engineering data, drawings, manuals, and spares list(s), and includes copies of the software. These originate from both the pharmaceutical manufacturer and the supplier. The documents must be verified as approved and on file under a document control system. The documentation must be located or stored in a controlled environment. 

---