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1. To perform good pharmaceutical industry practice (GxP). 2. To the knowledge of quality assurance audits, laboratory safety systems, and standard operating procedures 3. To learn grammar “must or should be V3”. 4. To learn grammar: question tag
Lesson 2: Quality assurance and auditing Objectives To perform good pharmaceutical industry practice (GxP) To knowledge quality assurance audits, laboratory safety systems, and standard operating procedures To learn grammar “must or should be - V3” To learn grammar: question tag What is GxP? GxP is an abbreviation for “good practice” The “x” is used to indicate the many different areas of “good practice” which are required by international regulatory authorities Good Auditing Practice /ɡʊd ˈɑː.dɪtɪŋ ˈpræk.tɪs/ Good Safety Practice /ɡʊd ˈseɪf.tiˈpræk.tɪs/ GSP Good Research GAP GRP Practice /ɡʊd rɪˈsɝːtʃ ˈpræk.tɪs/ GxP GMP Good Manufacturing Practice /ɡʊd ˌmæn.jəˈfæk.tʃə.rɪŋˈpræk.tɪs/ GCP GDP GLP Good Clinical Practice /ɡʊd ˈklɪn.ɪ.kəl ˈpræk.tɪs/ Good Documentation Practice /ɡʊd dɑː.kjə.menˈteɪ.ʃən ˈpræk.tɪs/ Good Laboratory Practice /ɡʊd ˈlæb.rə.tɔːr.i ˈpræk.tɪs/ Quality Assurance (QA) /ˈkwɑː.lə.t̬ i əˌʃʊr.əns/ VS Quality Control (QC) /ˈkwɑː.lə.t̬ i kənˌtroʊl/ QA QC A set of activities for ensuring quality in the processes by which products are developed A set of activities for ensuring quality in products The activities focus on identifying defects in the actual products produced Focused on Process Focused on Product Prevents defects Corrects defects Product sampling is the practice of sending free samples of your products to consumers Product sampling /ˈprɑː.dʌkt ˈsɑːmplɪŋ/ Poisonous or not pure Contaminated /kənˈtæm.ə.neɪ.t̬ ɪd/ Traceability is the ability to discover information about where and how a product was made Traceability /ˌtreɪsəˈbɪləti/ A product recall is defined as a request to return, exchange, or replace a product after discovering defects Product recall /ˈprɑː.dʌkt ˈriː.kɑːl/ The act of looking at something carefully to check that everything is correct and legal Inspection /ɪnˈspek.ʃən/ Write five suggestions for corrective action to solve the safety problems in the Berner Pharmaceuticals labs I suggest you dispose of toxic waste in the bins provided for this purpose … Read excerpts from Berner Pharmaceuticals’ SOP on laboratory procedures Then match them to warning to a-e All toxic waste materials must be disposed of properly Good sanitary hygiene must be practiced by all lab staff Protective clothing must be worn in the labs at all times Lab animals must be transported in covered cages Eye protection must be worn as signposted Discussing SOPs - Processes, documentation, timing procedures, Request information Please describe the procedure for the … process Would you please clarify how you …? Could you explain the procedure for the documentation of …? Asking questions What are the guidelines for …? How often you have to …? What special procedures you follow for …? How would you ensure good hygiene in the lab? Formulating SOP guidelines Proper protective clothing and safety equipment must be worn at all times Proper safety procedures must be carried out by laboratory staff Toxic or hazardous materials must be disposed of properly SOPs often use the following structure: Must or should be + Verb3 Example: Use safety SOPs for working with laboratory animals Safety SOPs must be used for working with laboratory animals Exercise: Formulate SOP guidelines Convert the following sentences Perform all wok with virus–infected animals in the bio-safety cabinet Use disinfectant on equipment following any experiments with the laboratory animals Wipe up all chemical spills in the laboratory immediately Wear laboratory gowns or lab coats, latex gloves, and safety glasses at all time Cover small biological agent spills with a partner towel and treat them with bleach Question tags Supply the missing question tags 10 11 12 13 14 15 The syringe is sterile, ? He’s not a consultant, ? This is the dispensary, ? She went home last week, ? It won’t hurt, ? There are enough beds, ? This equipment isn’t sterile, _? Nurse Brown admitted him, _? You will come tomorrow, ? You have given her a bedpan, ? Ward flower can be attractive, ? His condition is not better, _? The doctor can scrub up here, ? Supper isn’t ready yet, ? The treatment room wasn’t large, _? Complete the sentences with the correct prepositions ... ˈlæb.rə.tɔːr.i ˈpræk.tɪs/ Quality Assurance (QA) /ˈkwɑː.lə.t̬ i əˌʃʊr.əns/ VS Quality Control (QC) /ˈkwɑː.lə.t̬ i kənˌtroʊl/ QA QC A set of activities for ensuring quality in the processes by... industry, different quality assurance processes for each area of good practice (GxP) It is easiest to understand how good practice works in the area of manufacturing The quality assurance process...Objectives To perform good pharmaceutical industry practice (GxP) To knowledge quality assurance audits, laboratory safety systems, and standard operating procedures To learn grammar “must or should