DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Appearance/organoleptic(odor, color, taste)AssayHardness/friabilityDisintegration ordissolution rateMoisturecontentViscositypHMicrobial contentGranules/ ParticleSize variationRe-suspendabilityDrug Registration Guidance Document (<strong>DRGD</strong>)Testing Parameters of Stability Study for each type of dosage forms are shown inTable 12 below:Testing ParametersDosageFormOral powder √ √ √ √Hard capsule √ √ √ √ √Soft capsule √ √ √ √Coated and UncoatedTablet√√√(uncoated)√ √ √Coated and UncoatedPill/ Pellet√ √ √ √ √Suspension √ √ √ √ √ √ √Solution √ √ √ √ √Emulsion √ √ √ √ √Granules √ √ √ √ √*Notes:1. The list of tests for each product is not intended to be exhaustive, nor is it expected thatevery listed test to be included in the design of the stability study protocol for a particularfinished product.* Assay to determine the stability of a single active ingredient or a single marker/surrogateindicator that is susceptible to change during storage and is likely to influence quality shallbe sufficient to infer the overall stability of the TM/HS product irrespective of whether thefinished product contains single or multiple active ingredients.2. Justification must be given if one of the tests is not conducted for relevant dosage form.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 196
Drug Registration Guidance Document (<strong>DRGD</strong>)SECTION C: PARTICULARS OF PACKINGPackaging‣ Maximum pack size allowed for tablets, pills, capsules is based on dailydosing for a quantity not exceeding six (6) months usage.‣ Maximum pack size allowed with disease risk reduction claim for 1 monthsupply of products unless justified.‣ Product with dosage form of softgel with tail (twist and squeeze) shall comewith children proof cap.Packing particulars to the listing of packing as follows ;- C1: pack size and fill details by weight, or volume or quantity;- C2 : container type- C3 : Barcode/ serial No (optional);- C4 : recommended distributor‟s price (optional);- C5 : recommended retail price (optional);National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 197
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Page 146 and 147: Drug Registration Guidance Document
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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