Quality of medicines 0.0 / 5 ? PharmacyQuality of Meds UniversityNone Created by: RscottqubCreated on: 10-03-19 15:17 what 3 things must be proven in order to get to Market authorisation Safety. Quality. Efficacy 1 of 19 safety ensuring no dangerous side effects 2 of 19 Quality ensuring medicine meets the required standard 3 of 19 Efficacy ensuring medicine is used for its intended use 4 of 19 How can we ensure SQE? Restrict WHO can manufacture,supply and sell medicines 5 of 19 British Pharmacoepia contains standards which must be met. MHRA will inspect against this criteria 6 of 19 MHRA Medicines healthcare regulatory agency 7 of 19 Orange guide contains guidance for manufacturing procedures 8 of 19 GMP Good manufacturing practice - companies should combine knowledge from GMP and orange - GMP = more detailed than orange 9 of 19 It is required by law to comply with GMP TRUE 10 of 19 Adulterated passes chemical test inspections but was produced in such was that violates GMp 11 of 19 What should be done to prove GMP documentation of the manufacturing process 12 of 19 Quality assurance is GMP + QC. QA- review of the production of medicines 13 of 19 Examples of QA testing raw materials on arrival. Machine calibrating 14 of 19 3 key aspects of QA Elements. Soft elements. Competence 15 of 19 Elements controls, job management 16 of 19 Soft elements team morale, motivation, confidence etc 17 of 19 Competence knowledge, skills and qualifications- making sure you employ the right people 18 of 19 QA Vs QC QA- documentation, reviewing batch records. QC- TESTING - physical, chemical, biological stability etc 19 of 19
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