Pharmacopoeial Standards Flashcards
What is a pharmacopoeia?
Provides publicly available and legally enforceable quality control standards for common drugs, pharmaceutical chemicals, excipients, materials and preparations.
Standards are compliance requirements.
What does adherence to GMP ensure compliance with?
*safety-identify impurities,sterility
*quality-dissolution/disintegration testing, sterility
*purity-how to identify impurities, concn
*strength-uniformity of content, homogeneity of batch.
*identity-active ingredient, impurities
What is the Europeans Medicines agency responsible for?
Granting of marketing authorisations for human and vetinary medicines. Drug cannot be released to market without marketing authorisation.
What is the International Conference on harmonisation?
*Brings together regulatory authorities of Europe, Japan and US.
*Purpose is to achieve harmonisation of interpretation and application of guidelines in order to reduce duplicate testing in research and development of new meds.
*More economical, eliminates unnecessary delay of availability.
*This is done through pharmacopoeial discussion group (PDG)
*NOTE- EP doesn’t have product specific monographs, so only general monographs and methods harmonised.
What are the implications of brexit on regulation, authorisation and clinical trials processes?
*uk leave EU means separate authorisations and inspections- duplication,delay
