Pharmaceutical Auditing for OTC Drugs

Non-prescription medicines, commonly known as over the counter or OTC medicines, are used for treatment. Sales of over the counter medicines in pharmacy and grocery outlets reached £1268 5 million in 1994 about a third of the NHS drugs bill of C3 6 billion. In the late 1980s the government fuelled the over the counter market by making it easier to reclassify certain medicines from prescription only status to allow over the counter sale in pharmacies. Although all non-prescription medicines are required to hold a product licence, few have been evaluated in formal clinical trials in the setting in which they will be used. As a result many non-prescription products sold by pharmacists have been criticised for their lack of effectiveness. There are three legal categories of medicines prescription only medicine (POM), pharmacy medicine (P), and general sales list medicine (GSL); the last can be sold from outlets including supermarkets and drugstores. The principle of a class of medicines whose sale requires the supervision of a pharmacist is not unique to the United Kingdom.

 

  • Product traceability
  • Laboratory operations
  • Equipment validation
  • Review the do’s and don’ts during the auditBuilding and facility maintenance
  • Standardized grading scheme
  • Audit tools based on 21 CFR 210 & 211, ICH Q10
  • Audits, including capacity, quality assurance and post-market quality system verification

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