DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No.2.Type I: Minor changeReplacement, addition or deletionof company logo on the packagingcomponents (without any changeson graphic or label content)3. Change in product owner4. Change in importer/ store address5.6.7.8.Change or addition of imprints,bossing or other markings (exceptscoring/ break lines) on tablets orprinting on capsules, includingreplacement, or addition of inksused for product markingChange in shape or dimensions ofthe container or closure without anyother changesChange in pack size of the drugproduct (Finished product), withoutchange in primary packagingmaterial; or change in the numberor units (e.g. tablets, ampoules) in apack; or change in volume of nonsterile preparationsTightening of specification limits ofdrug product (finished product)and/or drug substance (activeingredient)VariationType II: Major changeChange in content of leaflet orprescribing information/ PatientInformation Leaflet (PIL)/ Summaryof Product Characteristics (SPC)Change in content of label inclusiveof change in graphics/ artworkChange in manufacturing process ofthe finished productChange in overage of activeingredient or excipientReplacement of an excipient with acomparable excipient and/or changein content of excipientChange in batch sizeChange in hard capsule shell (color,size or source)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 106
Drug Registration Guidance Document (<strong>DRGD</strong>)No.9.10.11.12.Type I: Minor changeChange in particular ofmanufacturer of drug substance(active ingredient ) without anychange in specification:- Change in manufacturer ofdrug substance- Addition of manufacturer ofdrug substance- Change in name and/orrephrasing of address of amanufacturer of drugsubstanceChange in secondary packagingmaterial (or change in any part ofthe primary packaging material thatis not in contact with the finishedproduct (e.g. color of flip off caps,color code rings on ampoules,change of needle shields i.e.different plastic used)Change in testing procedure of anexcipient.VariationType II: Major changeChange in finished product or activeingredient specification (includesaddition of a new test parameter)Change to in-process tests or limitsapplied during manufacture of theproductChange or addition in primarypackaging materialChange in shelf life of finishedproduct:- As packaged for sale- After first opening- After dilution/ reconstitution13. Change in storage conditions14.15.16.Appointment, deletion or change ofother manufacturersAddition or deletion of scoring/ breakline on tabletChange in test procedure oranalytical protocols of finishedproductNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 107
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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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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