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.
- Analysis and information on possible risk of incorrect or delayed diagnosis arising from non-prescription use
- Audit tools based on 21 CFR 210 & 211, ICH Q10
- Standardized grading scheme
- Building and facility maintenance
- Equipment validation
- Laboratory operations
- Product traceability
- Audits, including capacity, quality assurance and post-market quality system verification
Related Conference of Pharmaceutical Auditing for OTC Drugs
Pharmaceutical Auditing for OTC Drugs Conference Speakers
Recommended Sessions
- Analytical method Quality Auditing
- Audit Planning to Ensure Maximum Effectiveness and Efficiency
- Auditing Deviations, Product Complaints, and CAPA Systems
- Clinical and Bioanalytical laboratory Audits
- Clinical Audit in Pharmaceutical Development
- GMP in Food Industry
- Goals and Strategies to Meet Audit Requirements
- Importance of Audit in Pharmaceutical Industry
- Pharmaceutical Auditing for OTC Drugs
- Quality Assurance Audits in Pharma Industries
- Quality Assurance, Quality Control and Audit
- Quality Management System in Testing Laboratories
- Regulatory Affairs