§ Mr. Malcolm BruceTo ask the Secretary of State for Health if he will publish the quality assurance procedures currently in place within the Medicines Control Agency. [5948]
§ Mr. MaloneThe agency's performance is measured against a number of high level targets, set to protect public health in the field of medicinal products, which include targets related to standards of safety and quality. These are published in the agency's annual business plan and its accomplishments against them in its annual report, copies of which are available in the Library. The agency has in place a large number of standard operating procedures applicable to its many functions in order to meet its quality objectives. For example, the medicines inspectorate operates in compliance with the international quality system ISO 9002 and has achieved formal certification against this standard.
All agency procedures are subject to audit by the National Audit Office and internal Department of Health auditors.