DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 202
Drug Registration Guidance Document (<strong>DRGD</strong>)Example of Stability DataSTABLITY DATAPRODUCT NAME: TABLET ABC 500MG BATCH NO.:MANUFACTURING DATE: dd/mm/yy TEMPERATURE: 30 °C ± 2 °CEXPIRY DATE: dd/mm/yy RELATIVE HUMIDITY: 75 % ± 5%TestsProduct descriptionDisintegration testAssaysMicrobialContamination test:Total AerobicMicrobial CountSpecificationFilm-coated tablet,brownish in colourNMT 30 minuteseg: 90% -120% (ref….)NMT 2 x 10 4Frequency of Testing0 3 6 9 12 15 18 21 24Total Yeasts &Moulds CountTest for SpecifiedMicroorganismsNMT 2 x 10 2‣ NMT 2 x 10 2 CFU ofbile-tolerant gramnegativebacteria in1g or 1ml‣ Absence ofSalmonella in 10g or10ml‣ Absence ofEscherichia coli in1g or 1mlHeavy metal test:LeadArsenicMercuryCadmium‣ Absence ofStaphylococcus≤10.0 mg/kg (≤ 10ppm)≤5.0 mg/kg (≤ 5ppm)≤0.5 mg/kg (≤ 0.5ppm)≤0.3 mg/kg (≤ 0.3ppm)Conclusion ------------------------------------------------------------Analyst name: (signature) Verified by: (signature)Name:Name:DesignationDesignationDate:Date:National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 203
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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