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 3.2.A.1 FACILITIES AND EQUIPMENT.pdf     2024-APR-23 04:37:05   122k

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 3.2.A.2 ADVENTITIOUS AGENTS SAFETY EV..> 2024-APR-23 04:37:05   135k

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 3.2.A.3 NOVEL EXCIPIENTS.pdf             2024-APR-23 04:37:05   106k

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 3.2.P.1 DESCRIPTION AND COMPOSITION O..> 2024-APR-23 04:37:06    89k

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 3.2.P.2.1 COMPONENTS OF THE DRUG PROD..> 2024-APR-23 04:37:06   130k

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 3.2.P.2.2 DRUG PRODUCT (Formulation D..> 2024-APR-23 04:37:07   138k

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 3.2.P.2.3 MANUFACTURING PROCESS DEVEL..> 2024-APR-23 04:37:07   125k

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 3.2.P.2.4 CONTAINER CLOSURE SYSTEM.pdf   2024-APR-23 04:37:08   126k

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 3.2.P.2.5 MICROBIOLOGICAL ATTRIBUTES.pdf 2024-APR-23 04:37:08   125k

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 3.2.P.2.6 COMPATIBILITY.pdf              2024-APR-23 04:37:09   123k

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 3.2.P.3.1 MANUFACTURERS.pdf              2024-APR-23 04:37:09   120k

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 3.2.P.3.2 BATCH FORMULA.pdf              2024-APR-23 04:37:10   151k

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 3.2.P.3.3 DESCRIPTION OF MANUFACTURIN..> 2024-APR-23 04:37:10   130k

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 3.2.P.3.4 CONTROLS OF CRITICAL STEPS ..> 2024-APR-23 04:37:11   126k

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 3.2.P.3.5 PROCESS VALIDATION AND-OR E..> 2024-APR-23 04:37:11   126k

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 3.2.P.4.1 CONTROL OF EXCIPIENTS (Spec..> 2024-APR-23 04:37:12   143k

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 3.2.P.4.2 CONTROL OF EXCIPIENTS (Anal..> 2024-APR-23 04:37:12   140k

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 3.2.P.4.3 CONTROL OF EXCIPIENTS (Vali..> 2024-APR-23 04:37:13   143k

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 3.2.P.4.4 CONTROL OF EXCIPIENTS (Just..> 2024-APR-23 04:37:13   124k

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 3.2.P.4.5 CONTROL OF EXCIPIENTS (Exci..> 2024-APR-23 04:37:14   126k

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 3.2.P.4.6 CONTROL OF EXCIPIENTS (Nove..> 2024-APR-23 04:37:14   124k

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 3.2.P.5.1 SPECIFICATIONS.pdf             2024-APR-23 04:37:15   137k

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 3.2.P.5.2 ANALYTICAL PROCEDURES.pdf      2024-APR-23 04:37:15   141k

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 3.2.P.5.3 VALIDATION OF ANALYTICAL PR..> 2024-APR-23 04:37:16   139k

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 3.2.P.5.4 BATCH ANALYSES.pdf             2024-APR-23 04:37:16   145k

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 3.2.P.5.5 CHARACTERIZATION OF IMPURIT..> 2024-APR-23 04:37:17   125k

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 3.2.P.5.6 JUSTIFICATION OF SPECIFICAT..> 2024-APR-23 04:37:17   127k

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 3.2.P.6  REFERENCE STANDARDS OR MATER..> 2024-APR-23 04:37:18   100k

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 3.2.P.7 CONTAINER CLOSURE.pdf            2024-APR-23 04:37:18   102k

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 3.2.P.8.1 STABILITY SUMMERY AND CONCL..> 2024-APR-23 04:37:19   130k

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 3.2.P.8.2 POSTAPPROVAL STABILITY PROT..> 2024-APR-23 04:37:19   127k

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 3.2.P.8.3 STABILITY DATA.pdf             2024-APR-23 04:37:20   156k

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 3.2.R.1 REGIONAL INFORMATION.pdf         2024-APR-23 04:37:20   108k

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 3.2.R.2 METHODS VALIDATION PACKAGE.pdf   2024-APR-23 04:37:21   163k

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 3.2.S.1.1 GENERAL INFORMATION (Nomenc..> 2024-APR-23 04:37:21   155k

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 3.2.S.1.2 GENERAL INFORMATION (Struct..> 2024-APR-23 04:37:22   145k

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 3.2.S.1.3 GENERAL INFORMATION (Genera..> 2024-APR-23 04:37:22   157k

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 3.2.S.2.1 MANUFACTURE (Manufacturers)..> 2024-APR-23 04:37:23   144k

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 3.2.S.2.2 MANUFACTURE (Description of..> 2024-APR-23 04:37:23   137k

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 3.2.S.2.4 MANUFACTURE (Control of Cri..> 2024-APR-23 04:37:24   126k

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 3.2.S.2.5 MANUFACTURE (Process Valida..> 2024-APR-23 04:37:24   127k

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 3.2.S.3.1 CHARACTERIZATION (Elucidati..> 2024-APR-23 04:37:25   129k

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 3.2.S.3.2 CHARACTERIZATION (Impuritie..> 2024-APR-23 04:37:25   146k

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 3.2.S.4.1 CONTROL OF DRUG SUBSTANCE (..> 2024-APR-23 04:37:26   163k

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 3.2.S.4.2 CONTROL OF DRUG SUBSTANCE (..> 2024-APR-23 04:37:26   141k

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 3.2.S.4.3 CONTROL OF DRUG SUBSTANCE (..> 2024-APR-23 04:37:27   140k

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 3.2.S.4.4 CONTROL OF DRUG SUBSTANCE (..> 2024-APR-23 04:37:27   147k

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 3.2.S.4.5 CONTROL OF DRUG SUBSTANCE (..> 2024-APR-23 04:37:28   123k

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 3.2.S.5 REFERENCE STANDARDS.pdf          2024-APR-23 04:37:28    99k

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 3.2.S.6 CONTAINER CLOSURE.pdf            2024-APR-23 04:37:29   100k

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 3.2.S.7.1 STABILITY (Summery and Conc..> 2024-APR-23 04:37:29   128k

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 3.2.S.7.2 STABILITY (Post Approval St..> 2024-APR-23 04:37:30   146k

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 3.2.S.7.3 STABILITY (Stability Data).pdf 2024-APR-23 04:37:30   146k

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 Analytical Validation GLP Studies.pdf    2024-APR-23 04:37:31     5M

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 Computational prediction of genotoxic..> 2024-APR-23 04:37:31   107k

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 DMF Type I,II,III,IV 1Q2012ALLEXCEL.xls  2024-APR-23 04:37:32  4824k

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 DRAFT Guidance for Industry Analytica..> 2024-APR-23 04:37:33    80k

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 EMEA Guidance CLINICAL TRIAL IN EARLY..> 2024-APR-23 04:37:33   238k

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 EMEA Guidance Container Closure Ethyl..> 2024-APR-23 04:37:34    26k

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 EMEA Guidance GMPs.pdf                   2024-APR-23 04:37:35    62k

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 EMEA Guidance Guideline on the Chemis..> 2024-APR-23 04:37:36   201k

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 EMEA Guidance In-Use Shelf Life Testi..> 2024-APR-23 04:37:36    45k

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 EMEA Guidance Maximum Shelf Life for ..> 2024-APR-23 04:37:37    30k

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 EMEA Guidance Shelf Life Start Date.pdf  2024-APR-23 04:37:38    21k

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 EMEA Guidance for IMPD Links (MHRA).pdf  2024-APR-23 04:37:34   254k

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 EMEA Guidance for IMPDPreparation-Moc..> 2024-APR-23 04:37:35   238k

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 EMEA Guidance on 21P8 Shelf Life of D..> 2024-APR-23 04:37:37   139k

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 EMEA Guidance on 21S7 Retest Period f..> 2024-APR-23 04:37:38   139k

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 EMEA Guideline CTD IMPD Preparation C..> 2024-APR-23 04:37:38   139k

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 EU GUIDELINE ON THE LIMITS OF GENOTOX..> 2024-APR-23 04:37:39    50k

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 Example of Overall Quality Summery (2..> 2024-APR-23 04:37:39   227k

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 Excipient catagory and performance US..> 2024-APR-23 04:37:40   138k

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 Excipients IPEC GMP.pdf                  2024-APR-23 04:37:41   200k

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 Extractable Leachables Article.pdf       2024-APR-23 04:37:42     6M

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 FDA CMC Summery (Eric Duffy).pdf         2024-APR-23 04:37:42   301k

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 GMP News_ New FDA Guidance for the Pr..> 2024-APR-23 04:37:43   150k

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 Genotoxins.pdf                           2024-APR-23 04:37:43   670k

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 Guidance for Industry CMC for Peptide..> 2024-APR-23 04:37:45    28k

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 Guidance for Industry Container Closu..> 2024-APR-23 04:37:45   108k

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 Guidance for Industry Drug Product (C..> 2024-APR-23 04:37:46  1048k

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 Guidance for Industry Drug Substance ..> 2024-APR-23 04:37:46   252k

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 Guidance for Industry Genotoxic Agent..> 2024-APR-23 04:37:47   169k

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 Guidance for Industry IND Meetings.pdf   2024-APR-23 04:37:47    30k

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 Guidance for Industry INDs for Phase ..> 2024-APR-23 04:37:48    33k

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 Guidance for Industry Liposome Drug P..> 2024-APR-23 04:37:48    72k

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 Guidance for Industry M7 Assessment a..> 2024-APR-23 04:37:49   311k

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 Guidance for Industry NDA Annual Repo..> 2024-APR-23 04:37:49    23k

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 Guidance for Industry Out of Specific..> 2024-APR-23 04:37:50    98k

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 Guidance for Industry Post Approval C..> 2024-APR-23 04:37:50   134k

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 Guidance for Industry Post Approval C..> 2024-APR-23 04:37:51    60k

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 Guidance for Industry Post Approval C..> 2024-APR-23 04:37:51   117k

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 Guidance for Industry Post Approval C..> 2024-APR-23 04:37:52   173k

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 Guidance for Industry Specifications ..> 2024-APR-23 04:37:52   301k

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 Guidance for Industry Suspensions Inh..> 2024-APR-23 04:37:53   103k

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 Guidance for Industry cGMP for Phase ..> 2024-APR-23 04:37:44    92k

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 Guidance for Industry cGMPs for Phase..> 2024-APR-23 04:37:44   185k

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 Guidance for Industry non-Penicillili..> 2024-APR-23 04:37:49    51k

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 Guidance for Industry- CMC changes po..> 2024-APR-23 04:37:53   106k

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 Guidance for Industry- Content and Fo..> 2024-APR-23 04:37:54    12k

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 Guidance for Industry- When is an IND..> 2024-APR-23 04:37:54   134k

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 Guidance- Acyclovir Topical In-Vitro ..> 2024-APR-23 04:37:55   175k

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 Guidance- Cyclosporin In-Vitro Testin..> 2024-APR-23 04:37:55    23k

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 Guidances (Drugs)  Forced Degradation..> 2024-APR-23 04:37:55   197k

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 Guidances (Drugs) Development of New ..> 2024-APR-23 04:37:56   183k

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 ICH Guidelines Index.pdf                 2024-APR-23 04:37:56    78k

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 ICH M4 (R3) CTD Organization Question..> 2024-APR-23 04:37:57    77k

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 ICH M4(R3) CTD Organization.pdf          2024-APR-23 04:37:57   286k

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 ICH M4Q(R1) CTD Module 3 (Where thing..> 2024-APR-23 04:37:58   143k

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 ICH M4Q(R1) CTD Module 3 and Overal Q..> 2024-APR-23 04:37:58   267k

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 IIG FDA Inactive Ingredient List Sort..> 2024-APR-23 04:37:59   476k

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 IMPD Eudralex Volume 10 Comments on Q..> 2024-APR-23 04:38:00   188k

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 Industry Book of Knowlege Quality Ove..> 2024-APR-23 04:38:01   360k

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 Jacobson-Kram_2007_Advanced-Drug-Deli..> 2024-APR-23 04:38:01   108k

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 LABELLING 21 CFR 101.pdf                 2024-APR-23 04:38:02   146k

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 Literature AET USP 51 sutton 2002.pdf    2024-APR-23 04:38:02   329k

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 Literature Endotoxins USP 85 Review.pdf  2024-APR-23 04:38:03    10M

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 Literature Regulatory and Toxicology ..> 2024-APR-23 04:38:04   179k

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 Literature Risk Assessment of Genotox..> 2024-APR-23 04:38:05   917k

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 MHRA GMP Requirments.pdf                 2024-APR-23 04:38:07  2661k

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 MHRA Shelf Life IMPD Clinical API and..> 2024-APR-23 04:38:07    16k

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 Metal Catalysts- Draft- Jan 2007.pdf     2024-APR-23 04:38:05   257k

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 MethodsValidationPerPhase.pdf            2024-APR-23 04:38:06    41k

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 Nonsterile Semisolid Dosage Forms (SU..> 2024-APR-23 04:38:07   118k

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 Phase 1 GMP Exemption Jul 15 2008.pdf    2024-APR-23 04:38:08   102k

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 Q10 Pharmaceutical Quality System.pdf    2024-APR-23 04:38:09   433k

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 Q11 Development of APIs Training Intr..> 2024-APR-23 04:38:09   179k

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 Q11 Step 2 Development and Manufactur..> 2024-APR-23 04:38:10   436k

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 Q1A (R2) Stability New Drug Substance..> 2024-APR-23 04:38:10   210k

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 Q1B Photostability testing of New Dru..> 2024-APR-23 04:38:11   200k

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 Q1C Stability Testing of New Formulat..> 2024-APR-23 04:38:11    90k

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 Q1D (Step 4) Bracketing amd matrixing..> 2024-APR-23 04:38:12   197k

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 Q1E EVALUATION FOR STABILITY DATAd.pdf   2024-APR-23 04:38:12   211k

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 Q1E Presentation.pdf                     2024-APR-23 04:38:13    87k

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 Q2(R1) Validation of Analytical Proce..> 2024-APR-23 04:38:13   180k

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 Q3A(R2) Impurities in New Drug Substa..> 2024-APR-23 04:38:14   191k

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 Q3B(R2) Impurities in New Drug Produc..> 2024-APR-23 04:38:14   189k

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 Q3C (R5) Residual Solvents.pdf           2024-APR-23 04:38:15   205k

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 Q3D Elemental Impurities (Metals).pdf    2024-APR-23 04:38:16   766k

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 Q5C Stability for Biotechnology Produ..> 2024-APR-23 04:38:16   164k

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 Q6A Specification Decision Tree.pdf      2024-APR-23 04:38:17    46k

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 Q6A Specifications for New Drug Subst..> 2024-APR-23 04:38:17  1039k

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 Q7 Concept_Paper GMPs for Excipients ..> 2024-APR-23 04:38:18    32k

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 Q7 Good manufacturing Practice for AP..> 2024-APR-23 04:38:18   352k

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 Q7 Starting Material Questions and An..> 2024-APR-23 04:38:19   526k

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 Q8(R2) Pharmaceutical Development.pdf    2024-APR-23 04:38:20   764k

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 Q8-11 Quality by Design Training Modu..> 2024-APR-23 04:38:20   254k

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 Q9 Quality Risk management.pdf           2024-APR-23 04:38:21   205k

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 RFA-FD-12-020_ Effect of Physicochemi..> 2024-APR-23 04:38:22    63k

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 Reviewer Guidance Validation of Chrom..> 2024-APR-23 04:38:21   703k

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 Stability Site Changes FDA.pdf           2024-APR-23 04:38:22    16k

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 Topicals Biopharmaceutics (2013- FDA-..> 2024-APR-23 04:38:23   380k

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 USP Ophthalmic Preparations.pdf          2024-APR-23 04:38:24   455k

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 USP Topical and Transdermal Products.pdf 2024-APR-23 04:38:24  1308k