DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

More documents

Recommendations

Info

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 | 198
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 | 199
Page 1 and 2:
Drug Registration Guidance Document
Page 3 and 4:
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11:
Page 16 and 17:
Page 18 and 19:
Page 20 and 21:
Page 22 and 23:
Page 24 and 25:
Page 26 and 27:
Page 28 and 29:
Page 30 and 31:
Page 32 and 33:
Page 34 and 35:
Page 36 and 37:
Page 40 and 41:
Page 42 and 43:
Page 44 and 45:
Page 46 and 47:
Page 48 and 49:
Page 50 and 51:
Page 52 and 53:
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 68 and 69:
Page 70 and 71:
Page 72 and 73:
Page 74 and 75:
Page 76 and 77:
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
Page 86 and 87:
Page 88 and 89:
Page 90 and 91:
Page 92 and 93:
Page 94 and 95:
Page 96 and 97:
Page 98 and 99:
Page 100 and 101:
Page 102 and 103:
Page 104 and 105:
Page 106 and 107:
Page 108 and 109:
Page 110 and 111:
Page 112 and 113:
Page 114 and 115:
Page 116 and 117:
Page 118 and 119:
Page 120 and 121:
Page 122 and 123:
Page 124 and 125:
Page 126 and 127:
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134 and 135:
Page 136 and 137:
Page 138 and 139:
Page 140 and 141:
Page 142 and 143:
Page 144 and 145:
Page 146 and 147:
Page 148 and 149: Drug Registration Guidance Document
Page 202 and 203: Appearance/organoleptic(odor, color
Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231: ATTACHMENT 2Drug Registration Guida
Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
Page 248 and 249:
Page 250 and 251:
Page 252 and 253:
Page 254 and 255:
Page 256 and 257:
Page 258 and 259:
Page 260 and 261:
Page 262 and 263:
Page 264 and 265:
Page 266 and 267:
Page 268 and 269:
Page 270 and 271:
Page 272 and 273:
Page 274 and 275:
Route of AdministrationTAMC(CFU/g o
Page 276 and 277:
Page 278 and 279:
Page 280 and 281:
Page 282 and 283:
e) Example of label approved by the
Page 284 and 285:
Page 286 and 287:
Page 288 and 289:
Page 290 and 291:
Page 292 and 293:
Page 294 and 295:
Page 296 and 297:
Page 298 and 299:
Page 300 and 301:
Page 302 and 303:
Page 304 and 305:
Page 306 and 307:
Page 308 and 309:
Page 310 and 311:
Page 312 and 313:
Page 314 and 315:
Page 316 and 317:
Page 318 and 319:
Page 320 and 321:
Page 322 and 323:
Page 324 and 325:
Page 326 and 327:
Page 328 and 329:
Page 330 and 331:
Page 332 and 333:
Page 334 and 335:
Page 336 and 337:
Page 338 and 339:
Page 340 and 341:
Page 342 and 343:
Page 344 and 345:
Page 346 and 347:
Page 348 and 349:
Page 350 and 351:
Page 352 and 353:
Page 354 and 355:
Page 356 and 357:
Page 358 and 359:
Page 360 and 361:
Page 362 and 363:
Page 364 and 365:
Page 366 and 367:
Page 368 and 369:
Page 370 and 371:
Page 372 and 373:
Page 374 and 375:
Page 376 and 377:
Page 378 and 379:
Page 380 and 381:
Page 382 and 383:
Page 384 and 385:
Page 386 and 387:
Page 388 and 389:
Page 390 and 391:
Page 392 and 393:
Page 394 and 395:
Page 396 and 397:
Page 398 and 399:
Page 400 and 401:
Page 402 and 403:
Page 404 and 405:
Page 406 and 407:
Page 408 and 409:
Page 410 and 411:
Page 412 and 413:
Page 414 and 415:
Page 416 and 417:
Page 418 and 419:
Page 420 and 421:
Page 422 and 423:
Page 424 and 425:
Page 426 and 427:
Page 428 and 429:
Page 430 and 431:
Page 432 and 433:
Page 434 and 435:
Page 436 and 437:
Page 438 and 439:
Page 440 and 441:
Page 442 and 443:
Page 444 and 445:
Page 446 and 447:
Page 448 and 449:
Page 450 and 451:
Page 452 and 453:
Page 454 and 455:
Page 456 and 457:
Page 458 and 459:
Page 460 and 461:
Page 462 and 463:
Page 464 and 465:
Page 466 and 467:
Page 468 and 469:
Page 470 and 471:
Page 472 and 473:
Page 474 and 475:
Page 476 and 477:
Page 478 and 479:
Page 480 and 481:
Page 482 and 483:
Page 484 and 485:
Page 486 and 487:
Page 488 and 489:
Page 490 and 491:
Page 492 and 493:
Page 494 and 495:
Page 496 and 497:
Page 498 and 499:
Page 500:
show all

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?