DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 194
Drug Registration Guidance Document (<strong>DRGD</strong>)Stability study data checklists are as in Table 11 below:Data RequiredCompany nameProduct nameDosage formPackagingparticularsStorageconditionFrequency oftestingList of relevanttestsSpecificationsResults for eachtestApproval byauthorizedpersonRemarks- From product holder/ manufacturer/ third party lab- To be same with other documentation- To be same with A3- Material and pack size must be stated- To be same with C1- Temperature and humidity must be stated- Shall comply with ASEAN Zone IV requirement(30±2°C/75±5%RH)- If different storage condition (e.g. 25°C, 2-8°C), must providejustification/ supporting data.For example:- 0, 3, 6, 9, 12, 18, 24 months and annually for the proposedshelf life- All tests required for each dosage form shall be conducted,for example:o Physical appearance changeso Disintegration test (if applicable)o Chemical Assays for active ingredients (if applicable)o Microbial tests- Acceptance limit for each test must be stated- To be supported by established references (e.g. USP, BP) ifavailable- Must meet the specifications- Must have the name, post and signature of authorized personNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 195
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Page 144 and 145: Drug Registration Guidance Document
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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