DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Stability DataTable 9:No. Stability Study Shelf Life1. i) 2 batches of complete real-time stabilitystudy at 30 ± 2 ºC / RH 75± 5% for theclaimed shelf-life.ORii) 2 batches of on-going real timestability study ( at least 6 months) at 30 ± 2 ºC/ RH 75 ± 5% + Letter of commitment(LOC) to submit complete real time stabilitydata when study is complete/ whenrequested.AND- Shelf life will be basedon data stability at 30 o Cof not more than 5 years.- 3 years2 batches of 6 months accelerated stabilitystudy at 40ºC.2. i) 2 batches of complete real time stabilitystudy at a temperature and relative humidity(RH) different from the Zone IVB for at least 2years + LOC to conduct real time stabilitystudy at Zone IVB and submit when the studyis complete/ when requestedORii) 2 batches of on-going real time andaccelerated stability study (at least 6 months)at a temperature/ relative humidity (RH)different from Zone IVB + LOC to conduct realtime stability study at Zone IVB and submitwhen the study is complete/ when requested.3. 2 batches of complete real-time stability studyat temperature and RH other than zone IVB forvery unstable active ingredient(s)/ product(must be substantiated).- Shelf life will be basedon data stability atspecified temperature.- 2 years at specifiedtemperature in thestability study.- Shelf life will be basedon data stability atspecified temperature.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 192
Drug Registration Guidance Document (<strong>DRGD</strong>)Storage Conditions with Type of Container Closure System/ Stability StudyTable 10:No. Type of Container Closure System/ Study Storage Condition1.2.Products in primary containers permeableto water vapourProducts in primary containers impermeableto water vapour30°C + 2°C/75% RH +5%RH30°C + 2°C3. Accelerated studies40°C + 2°C/75% RH +5%RHReports of stability studies shall provide details of:the batches placed under study (a minimum of 2 batches are required).containers/ packaging type.conditions of storage during study (temperature, humidity, etc).duration of study and frequency (interval) of the tests/ observations.the tests performed and acceptance limits.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 193
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Page 214 and 215: ATTACHMENT 1Drug Registration Guida
Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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