AUDIT SCHEDULE … QUALITY ASSURANCE SERVICES

AUDIT SCHEDULE QUALITY ASSURANCE SERVICES PRODUCED BY A WORKING GROUP OF THE SCOTTISH QUALITY ASSURANCE SPECIALIST INTEREST GROUP September 2003 First Edition AUDIT SCHEDULE – QUALITY ASSURANCE SERVICES INTRODUCTION SCOPE Quality Assurance services to pharmacies This includes analytical and microbiological testing, medical gas testing and environmental monitoring This schedule contains some sections which may not be applicable to all areas audited: these should be omitted. AIMS OF A QUALITY ASSURANCE SERVICE To provide assurance that medicinal products supplied from, and services provided by, a pharmacy are fit for their intended purpose. AIMS OF THE AUDIT a) To assess compliance with agreed standards for quality assurance services b) To identify actions required to rectify shortcomings of the Quality Assurance service c) To ensure that pharmaceutical services are operating to agreed standards ACCEPTANCE CRITERIA a) A list of criteria has been drawn up by QA staff b) The criteria encompass various components of the service, e.g. personnel, sampling etc. c) The criteria will be reviewed and revised as necessary by the Scottish Quality Assurance Specialist Interest Group at regular intervals. METHODS OF MONITORING Auditors will use the following methods to assess compliance: ASSESS: Subjective views obtained from observation and/or discussion with ...