An appropriate infrastructure, encompassing the organizationalstructure, procedures, processes and resources necessary to ensureadequate con
dence that a product (or service) will satisfy givenrequirements for quality (
standard operating procedure (SOP)
An authorized written procedure giving instructions for performingoperations not necessarily speci
c to a given product or material butof a more general nature (e.g. equipment operation, maintenance andcleaning; validation; cleaning of premises and environmental control;sampling and inspection). Certain SOPs may be used to supplementproduct-speci
c master and batch production documentation (
3.1The structure, membership and operation of the GMP inspec-torate should be such that impartiality is safeguarded.3.2The national inspection services are responsible for ensuring thatthe requirements of the relevant national legislation are satis
ed.3.3All personnel employed or used by the GMP inspectorate, includ-ing outside inspectors or subcontracted personnel, should not besubject to any commercial,
nancial or other pressures which mightaffect their judgement. They should not be under the control of pharmaceutical manufacturers, and must be assessed and licensed.3.4The system for obtaining fees should not improperly in
uence theinspection procedure.
The administrative structure, membership, operation and legal statusof the GMP inspectorate should be described in the quality manual(see section 11).The quality manual should show how all personnel working for theGMP inspectorate, including subcontracted staff or advisers, andpersons serving on committees providing advice, can maintain theirimpartiality. The GMP inspectorate should ensure that such persons:(a)are not subject to any commercial,
nancial or other pressureswhich might in
uence their judgement;(b)are not improperly in
uenced in their inspection of pharmaceuti-cal manufacturers or persons assessed;(c)have not been involved in the design or maintenance of inspectedfacilities by way of any consultancy service or commercialarrangement.