Homework 4 – cGMPs, lab controls, STAR Whole class: Summarize Section 2.2 Drug P
ID: 53172 • Letter: H
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Homework 4 – cGMPs, lab controls, STAR Whole class: Summarize Section 2.2 Drug Product from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf “STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS Q1A This is biotechnology Homework 4 – cGMPs, lab controls, STAR Whole class: Summarize Section 2.2 Drug Product from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf “STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS Q1A This is biotechnology Homework 4 – cGMPs, lab controls, STAR Whole class: Summarize Section 2.2 Drug Product from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf “STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS Q1A This is biotechnology Homework 4 – cGMPs, lab controls, STAR Whole class: Summarize Section 2.2 Drug Product from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf “STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS Q1A This is biotechnologyExplanation / Answer
Drug product ;
The stability of the drug is studied based on the knowledge of behaviour and properties of the drug ,a photostability testing is done for the stability of the drug . Then batch selection is done for the drug atleast 3batches should be taken . first batch should be same for formulation and packed in same container closure system . other batches should be pilot scale batches ,and other should be smaller .stabiltiy should be done for the drug strength and container size .specification should be done for different drugs which includes quality ,safety ,efficacy ,and also should cover properties of the physichal , chemichal , microbial attributes ,preservative content ,and functional tests .analytical testing should be fully validated .shelf life of the drug should also considered
Testing frequency ;
the shelf life of the drug should atleast 12 months .storage condition should be minimum of 3points including final and intial points example 0, 3,6 . when expectations exits that result in accelerated testing for the given storage conditions .
storage conditions ;
drug product should be done for thermal stability and sensitivity for the moisture or potential loss for solvent loss .testing should be done for the constituted or diluted drug conditions . the long term conditions should cover a minimumof 12 months .for longterm condition should be temperature should be 25% ,relative humidity should be 5% . intermediate temperature should be 30% , RH will be 5%, for short term temperature should be 40% , Relative humudity is 5.
significant changes is seen in conditions of 5% change in assay ,any degradation process and failure to accept functional test
packing of the drug;
immpermeable container when drug is sentitive to moisture or content loss ,photosensitive . semi-permeable containers are used for the potential loss inaddition to physical or chemichal, biological and microbial stability . testing should be done for the water loss unedr high relative humidity is done . for semipermeable and permeable conditions
evaluation of drug ;
systematic approach is done which include ,physichal ,chemichal , biological ,microbial tests ,nature of degradation , loss of mositure is carefully examined ,time of refrigeration , thermal stability
statement of labelling ; this is done for regional /national requirements based on the evalulation of drug product .specific conditions should be seen such as storage ,temperature .
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