220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

93that the product conforms to its specification; the control of theenvironment or equipment may also be regarded as a part of thei.-p. control”.inspection Relevant authorities may conduct official inspectionse.g., of clinical investigators, sponsors, institutional reviewboards and laboratories in order to verify adherence to regulationsand GxP incl. good clinical practice and whether datasubmitted to authorities are substantiated by records; → see audit;types of i. are (FDA): “for cause” = as result of prior knowledgeor suspicion (e.g. study outside the speciality of the investigator,results inconsistent with those of other studies, study has beenpublicized, sponsor alerts the agency, etc.) of alleged violations ofregulations or when studies which are truly pivotal before the FDAare conducted outside the US; “expedited data audit” = directed atthose studies under current review in the Division of Biopharmaceutics,but no decision has been made on the approvability of theapplications the study support; “routine surveillance and assessement”= directed at those facilities not previously inspected; theresult of the inspection is the establishment inspection report;→ see also corrective and preventive actions, data quality,FDA 483 form, FDA 484 form, memorandum of understanding,quality assurance profile, self inspection.inspectional observations Observations (findings) during an inspectionare usually classified into three categories: (i) “critical o.”– i.e. Conditions, practices or processes that adversely affect therights, safety or well being of the subjects and/or the quality andintegrity of data. (ii) “major o.” – i.e. Conditions, practices or processesthat might adversely affect the rights, safety or well-being ofthe subjects and/or the quality and integrity of data. Major observationsare serious deficiencies and are direct violations of GCPprinciples; (iii) “other or minor o.” – i.e. Conditions, practices orprocesses that would not be expected to adversely affect the rights,safety or well being of the subjects and/or the quality and integrityof data; → see also audit, inspection.institution Any public or private entity or agency.institutional review board (IRB) Sometimes also institutional reviewcommittee; American term for ethics committee; any boardor other group formally designated by an institution to reviewbiomedical research involving humans as subject, to approve theinitiation of and conduct periodic review of such research (investigatorshave also to report all changes in research activity and allunanticipated problems involving risks to subjects); to meet FDArequirements an IRB shall have at least 5 members, with varyingbackgrounds, possessing the necessary professional competence,ins