Search for Pharmaceutical Quality Documents | FDA

The table below lists pharmaceutical quality-related guidances, MAPPs, and compliance programs. Use the type, topic, and search options separately or combined to narrow your results.Use type, topic, and search to find resources Type Compliance ProgramGuidanceMAPP Topic Administrative/ProceduralANDA (generic drugs)BiopharmaceuticsBLA (biologics)CGMPCompendial StandardsCompoundingContainer Closure/PackagingDMF (drug master files)Drug ProductDrug Substance/APIEmerging/Advanced TechExcipient/Inactive IngredientICHIND (investigational new drugs)Lifecycle ManagementMicrobiologyNDA (new drugs)Public Health EmergencySpecification and TestingStorage and DistributionOutsourcing Facility Inspections Clear Filters TitleTypeDateTopicOutsourcing Facility InspectionsCompliance Program1/15/2025Outsourcing Facility InspectionsConsiderations for Complying with 21 CFR 211.110Guidance1/6/2025Drug Product, CGMP, Emerging/Advanced TechMAPP 5018.3 Implementation of Established Conditions as Described in ICH Q12MAPP10/16/2024NDA (new drugs); ANDA (generic drugs); BLA (biologics); DMF (drug master files); Drug Substance/API; Drug Product; Lifecycle Management; ICH; Administrative/ProceduralReview of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFAGuidance10/17/2024ANDA (Generic Drugs); DMF (Drug Master Files); Drug Substance/APIContainer Closure System and Component Changes: Glass Vials and StoppersGuidance7/24/2024NDA (new drugs); ANDA (generic drugs); BLA (biologics); CGMP; Container Closure/Packaging; Lifecycle Management; Specification and TestingPostapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and AnswersGuidance7/23/2024BLA (biologics); Drug Product; CGMP; Lifecycle Management; Specification and TestingMAPP 5015.14 Prioritization of Solicited DMF Amendments Associated With ANDAs or PASs not Concurrently Under AssessmentMAPP5/3/2024DMF (drug master files); ANDA (generic drugs)Platform Technology Designation Program for Drug DevelopmentGuidance5/29/2024Multi-DisciplinaryReformulating Drug Products That Contain Carbomers Manufactured With BenzeneGuidance12/28/2023NDA (new drugs); ANDA (generic drugs); DMF (drug master files); Drug Product; CGMP; Compendial Standards; Lifecycle Management; Specification and Testing; Excipient/Inactive Ingredient; Biopharmaceutics; ICH2016 Medical Gas Container-Closure Rule Questions and AnswersGuidance1/17/2017CGMP; Administrative/Procedural; Container Closure/Packaging; Drug ProductAbuse-Deterrent Opioids — Evaluation and LabelingGuidance4/2/2015NDA (new drugs); Drug Substance/API; Drug Product; Container Closure/Packaging; Storage and Distribution; Excipient/Inactive Ingredient; ICH; Public Health EmergencyAdvanced Manufacturing Technologies Designation ProgramGuidance12/31/2024Emerging/Advanced Tech, Drug product, Drug Substance/API, Administrative/ProceduralAdvancement of Emerging Technology Applications for Pharmaceutical Innovation and ModernizationGuidance9/29/2017Emerging/Advanced TechnologyAllowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological ProductsGuidance6/25/2015ANDA (generic drugs); NDA (new drugs); BLA (biologics)Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAsGuidance12/1/2000ANDA (generic drugs); Drug Substance/APIAnalytical Procedures and Methods Validation for Drugs and BiologicsGuidance7/27/2015ANDA (generic drugs); NDA (new drugs); BLA (biologics); Lifecyle ManagementANDAs: Impurities in Drug ProductsGuidance11/29/2010Drug Product; ANDA (generic drugs); ICH; Specification and TestingANDAs: Impurities in Drug SubstancesGuidance7/15/2009ANDA (generic drugs); Drug Substance/APIANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls InformationGuidance7/9/2007Drug Substance/API; Drug Product; ANDA (generic drugs); Specification and TestingANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug SubmissionsGuidance12/2/2022ANDA (generic drugs); DMF (drug master files); Administrative/Procedural; Drug Product; Drug Substance/APIANDAs: Stability Testing of Drug Substances and ProductsGuidance6/20/2013ANDA (generic drugs); Specification and Testing; Drug Substance/API; Drug ProductANDAs: Stability Testing of Drug Substances and Products, Questions and AnswersGuidance5/15/2014ANDA (generic drugs); Specification and Testing; Container Closure/Packaging; Drug Substance/API; Drug ProductANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA OriginGuidance5/19/2021ANDA (generic drugs); NDA (new drugs); Specification and Testing; Drug ProductAssessment of Abuse Potential of DrugsGuidance1/18/2017NDA (new drugs); IND (investigational new drugs); Drug Substance/API; Drug Product; Storage and Distribution; ICH; Administrative/Procedural; Public Health EmergencyBenefit-Risk Considerations for Product Quality AssessmentsGuidance5/9/2022NDA (new drugs); BLA (biologics); ANDA (generic drugs); Drug Product; Drug Substance/API; Lifecycle ManagementBest Practices in Developing Proprietary Names for Human Prescription Drug ProductsGuidance12/8/2020Administrative/Procedural; Drug Product; Container Closure/PackagingBioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local ActionGuidance4/3/2003Specification and Testing; Biopharmaceutics; Lifecycle Management; Drug Substance/API; NDA (new drugs); ANDA (generic drugs); Compendial Standards; Drug Product; Storage and DistributionBioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General ConsiderationsGuidance3/18/2014IND (investigational new drugs); NDA (new drugs); Drug Product; Lifecycle Management; Drug Substance/API; Biopharmaceutics; Storage and DistributionBotanical Drug DevelopmentGuidance12/29/2016IND (investigational new drugs); ANDA (generic drugs); NDA (new drugs); BLA (biologics); Drug ProductCannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical ResearchGuidance1/23/2023Drug Substance/API; IND (investigational new drugs); NDA (new drugs); Specification and TestingCDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical QualityGuidance7/26/2023IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); BLA (biologics); Compendial Standards; Administrative/ProceduralCGMP for Phase 1 Investigational DrugsGuidance7/14/2008IND (investigational new drugs); CGMPThe "Deemed to be a License" Provision of the BPCI Act: Questions and AnswersGuidance3/4/2020NDA (new drugs); BLA (biologics); Administrative/Procedural; Lifecycle ManagementDemonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived ProductsGuidance04/1/1996BLA (biologics); CGMP; Specification and TestingDetermining Whether to Submit an ANDA or a 505(b)(2) ApplicationGuidance5/10/2019NDA (new drugs); ANDA (generic drugs); Drug Product; Container Closure/Packaging; Excipient/Inactive Ingredient; Administrative/ProceduralDevelopment and Submission of Near Infrared Analytical ProceduresGuidance8/6/2021NDA (new drugs); ANDA (generic drugs); DMF (drug master files); Drug Product; Drug Substance/API; ICH; CGMP; Lifecycle Management; Administrative/Procedural; Specification and TestingDevelopment of New Stereoisomeric DrugsGuidance5/1/1992Drug Product; Drug Substance/API; CGMPDissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug SubstancesGuidance8/9/2018Specification and Testing; ANDA (generic drugs); NDA (new drugs); IND (investigational new drugs); Drug Substance/API; ICH; BiopharmaceuticsDissolution Testing of Immediate Release Solid Oral Dosage FormsGuidance8/25/1997Lifecycle Management; Drug Product; Biopharmaceutics; NDA (new drugs); ANDA (generic drugs); Excipient/Inactive Ingredient; Compendial Standards; ICHDrug Master FilesGuidance11/15/2019Drug Substance/API; Administrative/Procedural; DMF (drug master files)Drug Master Files for Bulk Antibiotic Drug SubstancesGuidance11/29/1999DMF (drug master files); administrativeDrug Products, Including Biological Products, that Contain NanomaterialsGuidance4/21/2022Drug Product; NDA (new drugs); ANDA (generic drugs); BLA (biologics); DMF (drug master files); IND (investigational new drugs); emerging/advanced tech; Specification and Testing; Drug Substance/API; Excipient/Inactive Ingredient; CGMP; Lifecycle Management; Storage and DistributionElemental Impurities in Drug ProductsGuidance8/8/2018ICH; Compendial Standards; NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Product; Compendial StandardsEnvironmental Assessment of Human Drug and Biologics ApplicationsGuidance7/27/1998NDA (new drugs); IND (investigational new drugs); BLA (biologics); Drug ProductEnvironmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid ActivityGuidance3/4/2016IND (investigational new drugs); ANDA (generic drugs); BLA (biologics); Administrative/Procedural; Drug ProductExpanded Access to Investigational Drugs for Treatment Use—Questions and AnswersGuidance6/3/2016IND (investigational new drugs); Drug Product; Administrative/ProceduralExpiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing IronGuidance6/9/1997Specification and Testing; Storage and DistributionExpiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug ProductsGuidance7/29/2020CGMP; Specification and Testing; Storage and DistributionExtended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo CorrelationsGuidance9/1/1997Lifecycle Management; NDA (new drugs); ANDA (generic drugs); Specification and Testing; Drug Product; Excipient/Inactive Ingredient; Compendial StandardsExtending Expiration Dates of Doxycycline Tablets and Capsules in Strategic StockpilesGuidance4/24/2019Public Health Emergency; CGMP; Drug Product; Storage and DistributionFacility Readiness: Goal Date Decisions Under GDUFAGuidance6/18/2024ANDA (generic drugs); Drug Substance/API; Drug Product; CGMP; Administrative/ProceduralFDA Oversight of PET Drug Products Questions and AnswersGuidance12/3/2012Drug Product; ICH; CGMP; Administrative/Procedural; Specification and Testing; Container Closure/PackagingField Alert Report Submission: Questions and AnswersGuidance7/22/2021NDA (new drugs); ANDA (generic drugs); Specification and Testing; Drug ProductFixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFARGuidance8/2/2023Drug Product; Biopharmaceutics; Specification and Testing; Lifecycle Management; Administrative/ProceduralFormal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMPGuidance1/11/2006CGMP; Administrative/ProceduralFormat and Content for the CMC Section of an Annual ReportGuidance9/1/1994NDA (new drugs); ANDA (generic drugs); Lifecycle Management; emerging/advanced techGeneral Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug ProductsGuidance11/21/17ANDA (generic drugs); Specification and Testing; Drug ProductGlass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4Guidance3/31/2013NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs); Drug Product; Container Closure/Packaging; Storage and DistributionHarmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph ProcessGuidance7/10/2019DMF (drug master files); Compendial Standards; Drug Product; Specification and TestingHeparin for Drug and Medical Device Use: Monitoring Crude Heparin for QualityGuidance6/25/2013CGMP; Drug Substance/API; Drug Product; Compendial Standards; Specification and Testing; ICHICH Q12: Implementation Considerations for FDA-Regulated ProductsGuidance5/20/2021ICH; Lifecycle Management; CGMP; NDA (new drugs); ANDA (generic drugs); BLA (biologics)Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and AnswersGuidance10/22/2019NDA (new drugs); ANDA (generic drugs); BLA (biologics); Administrative/ProceduralImmunogenicity Assessment for Therapeutic Protein ProductsGuidance8/14/2014BLA (biologics); IND (investigational new drugs); Drug Product; Container Closure/Packaging; Storage and DistributionImmunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody DetectionGuidance2/19/2019IND (investigational new drugs); CGMPImmunogenicity-Related Considerations for Low Molecular Weight HeparinGuidance2/18/2016ANDA (generic drugs); NDA (new drugs); DMF (drug master files); Lifecycle ManagementIncorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for AnticounterfeitingGuidance10/11/2011NDA (new drugs); ANDA (generic drugs); Drug Product; Lifecycle ManagementIND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical RecommendationsGuidance12/8/2021IND (investigational new drugs); Drug ProductINDs for Phase 2 and Phase 3 Studies: Chemistry, Manufacturing, and Controls InformationGuidance5/20/2003Drug Substance/API; Drug Product; IND (investigational new drugs); CGMPInspection of Injectable Products for Visible ParticulatesGuidance12/16/2021Drug Product; CGMP; Compendial Standards; Container Closure/Packaging; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Specification and Testing; Lifecycle ManagementInterim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic ActGuidance6/10/2016BLA (biologics); IND (investigational new drugs); Drug Substance/API; Drug Product; Container Closure/Packaging; Compounding; Storage and DistributionInterim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic ActGuidance6/10/2016BLA (biologics); IND (investigational new drugs); Drug Substance/API; Drug Product; Container Closure/Packaging; Compounding; Storage and DistributionInterpretation of the "Deemed to be a License" Provision of the Biologics Price Competition and Innovation Act of 2009Guidance12/12/2018Administrative/Procedural; Lifecycle ManagementInvestigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionGuidance5/16/2022Specification and Testing; CGMP; Administrative/ProceduralInvestigational New Drug Applications for Positron Emission Tomography (PET) DrugsGuidance12/3/2012IND (investigational new drugs); Specification and Testing; Drug Product; NDA (new drugs); CGMP; ANDA (generic drugs); Specification and Testing; Compendial Standards; DMF; Container Closure/Packaging; Drug Substance/API; Storage and DistributionInvestigational New Drug Applications Prepared and Submitted by Sponsor-InvestigatorsGuidance5/15/2015IND (investigational new drugs); Drug Product; Administrative/Procedural; Specification and Testing; Container Closure/Packaging; Storage and DistributionLabeling for Biosimilar ProductsGuidance7/18/2018BLA (biologics); Administrative/ProceduralLimiting the Use of Certain Phthalates as Excipients in CDER-Regulated ProductsGuidance12/6/2012IND (investigational new drugs); NDA (new drugs); BLA (biologics); ANDA (generic drugs); Drug Product; excipients/inactive ingredientsLiposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling DocumentationGuidance4/5/2018NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Product; BiopharmaceuticsMedia Fills for Validation of Aseptic Preparations for Positron Emission TomographyGuidance4/11/2012CGMP; Specification and Testing; MicrobiologyMetered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality ConsiderationsGuidance4/19/2018Drug Product; Container Closure/Packaging; Storage and Distribution; Specification and Testing; Compendial Standards; MicrobiologyMicrobiological Quality Considerations in Non-sterile Drug ManufacturingGuidance9/29/2021CGMP; Microbiology; NDA (new drugs); ANDA (generic drugs); Drug Product; Drug Substance/API; Lifecycle Management; Compendial Standards; Specification and Testing; Container Closure/Packaging; Storage and Distribution; Administrative/ProceduralMixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License ApplicationGuidance1/18/2018BLA (biologics); Drug Substance/API; Drug Product; CGMP; Container Closure/Packaging; Compounding; Storage and Distribution; Excipient/Inactive IngredientMonoclonal Antibodies Used as Reagents in Drug ManufacturingGuidance3/1/2001NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs); Drug Substance/API; MicrobiologyNaming of Drug Products Containing Salt Drug SubstancesGuidance6/17/2015Drug Product; Drug Substance/API; Compendial Standards; NDA (new drugs); ANDA (generic drugs); Administrative/ProceduralNasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls DocumentationGuidance7/5/2002Specification and Testing; Drug Product; Compendial StandardsNDAs: Impurities in Drug SubstancesGuidance2/1/2000NDA (new drugs); Drug Substance/API; Specification and Testing; ICH; Compendial StandardsNon-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-ContaminationGuidance4/17/2013CGMP; Drug Substance/API; ICH; Storage and DistributionNon-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-ContaminationGuidance6/24/2022CGMP; Drug Product; Drug Substance/API; Lifecycle Management; Specification and TestingNonproprietary Naming of Biological ProductsGuidance1/17/2017BLA (biologics); Administrative/ProceduralOral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling RecommendationsGuidance6/2/2021Specification and Testing; Drug Product; NDA (new drugs); ANDA (generic drugs); IND (investigational new drugs)Orally Disintegrating TabletsGuidance12/16/2008ANDA (generic drugs); NDA (new drugs); Drug Product; Specification and Testing; Compendial StandardsPAC-ATLS: Postapproval Changes—Analytical Testing Laboratory SitesGuidance4/28/1998NDA (new drugs); ANDA (generic drugs); Lifecycle ManagementPAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality AssuranceGuidance10/4/2004CGMP; NDA (new drugs); ANDA (generic drugs); BLA (biologics)PET Drug Applications—Content and Format for NDAs and ANDAsGuidance8/31/2011Administrative/Procedural; Drug Product; Specification and Testing; Compendial Standards; CGMP; ICHPET Drug Products—Current Good Manufacturing Practice (CGMP)Guidance12/10/2009CGMP; Drug ProductPharmaceutical Components at Risk for Melamine ContaminationGuidance8/6/2009Drug Substance/API; Drug Product; CGMP; Specification and Testing; Excipient/Inactive IngredientPlanning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug ProductsGuidance3/15/2011Public Health Emergency; Administrative/Procedural; Drug Product; CGMPPoints to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human UseGuidance2/28/1997CGMP; Microbiology, Drug Product; Specification and Testing; Container Closure/Packaging; Storage and DistributionPostapproval Changes to Drug SubstancesGuidance9/11/2018ANDA (generic drugs); NDA (new drugs); DMF (drug master files); Drug Substance/API; Lifecycle ManagementPotassium Iodide Tablets—Shelf Life ExtensionGuidance3/08/2004Public Health Emergency; Drug Product; Specification and Testing; Storage and Distribution; Biopharmaceutics; Compendial StandardsPotency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral PathogensGuidance3/1/2023IND (investigational new drugs); BLA (biologics); Specification and TestingPreparation of Investigational New Drug Products (Human and Animal)Guidance11/1/1992CGMP; NDA (new drugs); ANDA (generic drugs); BLA (biologics)Process Validation: General Principles and PracticesGuidance1/25/2011CGMP; ICH; Specification and Testing; Drug Product; Drug Substance/APIPyrogen and Endotoxins Testing: Questions and AnswersGuidance6/1/2012CGMP; Specification and Testing; Microbiology; Compendial StandardsQ&A on CGMP RequirementsGuidance9/15/2022Container Closure/Packaging; CGMP; Storage and Distribution; Administrative/Procedural; Specification and TestingQ1A(R2) Stability Testing of New Drug Substances and ProductsGuidance11/21/2003ANDA (generic drugs); ICH; Specification and Testing; NDA (new drugs); Drug Substance/API; Drug Product; Storage and Distribution; Container Closure/Packaging; Microbiology; BiopharmaceuticsQ1B Photostability Testing of New Drug Substances and ProductsGuidance3/7/1996ICH; Specification and Testing; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Container Closure/PackagingQ1C Stability Testing for New Dosage FormsGuidance5/9/1997ICH; Specification and Testing; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Storage and Distribution; Container Closure/PackagingQ1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and ProductsGuidance1/16/2003ICH; Specification and Testing; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Storage and Distribution; Container Closure/PackagingQ1E Evaluation of Stability DataGuidance6/8/2004ICH; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Storage and Distribution; Specification and Testing; Container Closure/Packaging; BiopharmaceuticsQ2(R1) Validation of Analytical Procedures: Text and MethodologyGuidance9/16/2021ICH; Specification and TestingQ3A Impurities in New Drug SubstancesGuidance6/6/2008ICH; Drug Substance/API; NDA (new drugs); ANDA (generic drugs); Specification and Testing; Storage and Distribution; CGMPQ3B(R2) Impurities in New Drug ProductsGuidance8/4/2006ICH; NDA (new drugs); ANDA (generic drugs); Drug Product; Excipient/Inactive Ingredient; Container Closure/Packaging; Specification and Testing; Storage and Distribution; CGMPQ3C Impurities: Residual SolventsGuidance12/24/1997ICH; Specification and Testing, NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Excipient/Inactive IngredientQ3C—Tables and ListGuidance8/1/2018ICH; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Excipient/Inactive IngredientQ3D(R2) Elemental ImpuritiesGuidance9/14/2022ICH; NDA (new drugs); ANDA (generic drugs); Drug Product; Specification and Testing; CGMP; Container Closure/Packaging; Excipient/Inactive IngredientQ4B Annex 10(R1): Polyacrylamide Gel Electrophoresis General ChapterGuidance9/2/2010NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 11: Capillary Electrophoresis General ChapterGuidance9/3/2010NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 12: Analytical Sieving General ChapterGuidance9/2/2010NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 13: Bulk Density and Tapped Density of Powders General ChapterGuidance5/28/2013NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 14: Bacterial Endotoxins Test General ChapterGuidance10/23/2013NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 2(R1): Test for Extractable Volume of Parenteral Preparations General ChapterGuidance9/18/2017NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Drug Product; Specification and TestingQ4B Annex 3(R1): Test for Particulate Contamination: Subvisible Particles General ChapterGuidance1/9/2009NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Drug Product; Specification and Testing; CGMPQ4B Annex 4A(R1): Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General ChapterGuidance4/8/2009NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; Microbiology; Drug ProductQ4B Annex 4B(R1): Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General ChapterGuidance4/8/2009NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; Microbiology; Drug ProductQ4B Annex 4C(R1): Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General ChapterGuidance4/8/2009NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; Microbiology; Drug Product; Drug Substance/APIQ4B Annex 5(R1): Disintegration Test General ChapterGuidance12/23/2009NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; Drug ProductQ4B Annex 6: Uniformity of Dosage Units General ChapterGuidance6/16/2014NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 7(R2): Dissolution Test General ChapterGuidance6/24/2011NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; CGMPQ4B Annex 8(R1): Sterility Test General ChapterGuidance12/22/2009NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 9(R1): Tablet Friability General ChapterGuidance4/5/2010NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; Drug ProductQ4B Annex I(R1): Residue on Ignition/Sulphated Ash General ChapterGuidance2/21/2008NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH RegionsGuidance2/20/2008NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal OriginGuidance11/10/2022ICH; Specification and Testing; BLA (biologics); Drug Substance/API; Drug Product; CGMPQ5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein ProductsGuidance2/23/1996ICH; Specification and Testing; BLA (biologics)Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological ProductsGuidance7/1/1996ICH; Specification and Testing; BLA (biologics); Drug Substance/API; Drug Product; Excipient/Inactive Ingredient; Storage and Distribution; Container Closure/PackagingQ5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological ProductsGuidance9/21/1998ICH; Specification and Testing; BLA (biologics); Drug Substance/API; Drug ProductQ5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing ProcessGuidance6/30/2005ICH; BLA (biologics); Drug Substance/API; Drug Product; Lifecycle Management; Specification and Testing; CGMPQ6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesGuidance12/29/2000ICH; Specification and Testing; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Compendial Standards; CGMP; MicrobiologyQ6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological ProductsGuidance8/18/1999ICH; Specification and Testing; BLA (biologics); Drug Substance/API; Drug Product; Compendial Standards; CGMPQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical IngredientsGuidance9/30/2016ICH; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Drug Substance/API; CGMP; Container Closure/Packaging; Specification and Testing; Storage and Distribution; MicrobiologyQ8(R2) Pharmaceutical DevelopmentGuidance11/20/2009ICH; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Administrative/Procedural; Drug Product; Drug Substance/API; Excipient/Inactive Ingredient; Container Closure/Packaging; Microbiology; Specification and Testing; CGMPQ9(R1) Quality Risk ManagementGuidance5/3/2023ICH; Drug Product; Drug Substance/API; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Excipient/Inactive Ingredient; Container Closure/Packaging; Storage and Distribution; Specification and Testing; CGMPQ10 Pharmaceutical Quality SystemGuidance4/8/2009ICH; CGMP; Drug Substance/API; Drug Product; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Container Closure/Packaging; Storage and DistributionQ11 Development and Manufacture of Drug SubstancesGuidance11/20/2012NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Drug Substance/API; Administrative/Procedural; Specification and Testing; Microbiology; CGMPQ11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)—Questions and AnswersGuidance2/26/2018NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Drug Substance/API; CGMP; Specification and Testing; Administrative/ProceduralQ12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle ManagementGuidance5/11/2021Lifecycle Management; ICH; NDA (new drugs); ANDA (generic drugs); BLA (biologics)Q13 Continuous Manufacturing of Drug Substances and Drug ProductsGuidance3/1/2023ICH; emerging/advanced tech; Drug Substance/API; Drug Product; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Lifecycle Management; CGMPQuality Attribute Considerations for Chewable TabletsGuidance8/21/2018Drug Product; Administrative/Procedural; NDA (new drugs); ANDA (generic drugs); IND (investigational new drugs); Compendial StandardsQuality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference ProductGuidance4/30/2015IND (investigational new drugs); BLA (biologics); ICH; Specification and Testing; Drug Product; Excipient/Inactive Ingredient; Drug Substance/API; Storage and DistributionQuality Systems Approach to Pharmaceutical CGMP RegulationsGuidance10/2/2006ICH; CGMP; Drug Substance/API; Drug Product; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Container Closure/Packaging; Storage and DistributionQuestions and Answers on Quality Related Controlled CorrespondenceGuidance9/20/2021ANDA (generic drugs); DMF (drug master files); Drug Product; Drug Substance/API; Microbiology; Container Closure/Packaging; Compendial Standards; Specification and Testing; BiopharmaceuticsRegulatory Classification of Pharmaceutical Co-CrystalsGuidance2/15/2018NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Substance/APIRemote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring FacilitiesGuidance10/25/2023NDA (new drugs); ANDA (generic drugs); BLA (biologics); CGMPRepackaging of Certain Human Drug Products by Pharmacies and Outsourcing FacilitiesGuidance1/13/2017Drug Product; CGMP; Container Closure/Packaging; Compounding; Storage and DistributionReporting Amount of Listed Drugs and Biological Products Technical Conformance GuideGuidance10/29/2021BLA (biologics); NDA (new drugs); Drug Product; Drug Substance/APIReports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997Guidance2/16/2006Specification and Testing; Lifecycle Management; Administrative/ProceduralResidual Drug in Transdermal and Related Drug Delivery SystemsGuidance8/17/2011IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); Drug Product; Lifecycle ManagementResidual Solvents in Drug Products Marketed in the United StatesGuidance11/25/2009NDA (new drugs); ANDA (generic drugs); Drug Product; Compendial Standards; ICHReview of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFAGuidance10/3/2022DMF (drug master files); ANDA (generic drugs); Drug Substance/API; Administrative/ProceduralReviewer Guidance, Validation of Chromatographic MethodsGuidance11/1/1994Drug Substance/API; Drug Product; Lifecycle ManagementRisk Management Plans To Mitigate the Potential for Drug ShortagesGuidance5/19/2022CGMP; Drug Product; Drug Substance/API; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Lifecycle Management; Public Health Emergency; Storage and DistributionScientific Considerations in Demonstrating Biosimilarity to a Reference ProductGuidance4/28/2015BLA (biologics); Drug Product; Specification and Testing; Lifecycle Management; Drug Substance/API; Storage and DistributionSelection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human UseGuidance10/3/2018NDA (new drugs); ANDA (generic drugs); BLA (biologics); Container Closure/Packaging; Drug Product; Administrative/ProceduralSize of Beads in Drug Products Labeled for SprinkleGuidance5/16/2012ANDA (generic drugs); NDA (new drugs); BLA (biologics); Drug ProductSize, Shape, and Other Physical Attributes of Generic Tablets and CapsulesGuidance10/3/2022ANDA (generic drugs); Drug ProductStatistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999Guidance4/11/2003Container Closure/PackagingSterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing PracticeGuidance10/4/2004CGMP; MicrobiologySubmission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug ProductsGuidance11/1/1994NDA (new drugs); ANDA (generic drugs); BLA (biologics); CGMP; Storage and Distribution; Specification and Testing; Microbiology; Container Closure/Packaging; Drug ProductSubmission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat ProcessesGuidance2/26/2010CGMP; Storage and Distribution; Specification and Testing; Microbiology; Container Closure/Packaging; Drug ProductSUPAC: Manufacturing Equipment AddendumGuidance12/2/2014NDA (new drugs); ANDA (generic drugs); Lifecycle ManagementSUPAC-IR Questions and Answers about SUPAC-IR GuidanceGuidance2/18/1997NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Biopharmaceutics; Specification and Testing; Excipient/Inactive IngredientSUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence DocumentationGuidance11/1/1995NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Biopharmaceutics; Specification and Testing; Excipient/Inactive IngredientSUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence DocumentationGuidance10/6/1997NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Biopharmaceutics; Specification and Testing; Excipient/Inactive IngredientSUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence DocumentationGuidance5/1/1997NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Biopharmaceutics; Specification and Testing; Excipient/Inactive IngredientTablet Scoring: Nomenclature, Labeling, and Data for EvaluationGuidance3/13/2013ANDA (generic drugs); Drug Product; Lifecycle Management; Specification and TestingTechnical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological ProductsGuidance6/7/2013ANDA (generic drugs); NDA (new drugs); IND (investigational new drugs); BLA (biologics); Drug Product; Specification and TestingTesting of Glycerin for Diethylene GlycolGuidance5/8/2023Excipient/Inactive Ingredient; CGMP; Compendial StandardsThe Use of Mechanical Calibration of Dissolution Apparatus 1 and 2—Current Good Manufacturing Practice (CGMP)Guidance1/27/2010Biopharmaceutics; Compendial Standards; CGMP; Drug Product; Specification and TestingThe Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and ControlsGuidance9/30/2020Biopharmaceutics; ANDA (generic drugs); NDA (new drugs); IND (investigational new drugs); Drug Product; Lifecycle ManagementTransdermal and Topical Delivery Systems - Product Development and Quality ConsiderationsGuidance11/21/2019NDA (new drugs); ANDA (generic drugs); Drug Product; Specification and TestingType V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or SoftwareGuidance10/29/2019DMF (drug master files); Drug Product; Administrative/ProceduralUse of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality AssessmentsGuidance7/25/2018Drug Product; Compendial Standards; Specification and Testing; BiopharmaceuticsUsing the Inactive Ingredient DatabaseGuidance7/11/2019NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Product; Excipient/Inactive IngredientPreapproval Inspections (7346.832)Compliance Program10/17/2022CGMP; Drug Product; Drug Substance/API; ICH; DMF (drug master files); ANDA (generic drugs); NDA (new drugs); Specification and Testing; Microbiology; Excipient/Inactive Ingredient; Compendial Standards; Container Closure/Packaging; lifecycle managament; Storage and DistributionInspections of CDER-Led or CDRH-Led Combination Products (7356.000)Compliance Program6/4/2020CGMP; NDA (new drugs); ANDA (generic drugs); BLA (biologics)Drug Manufacturing Inspections (7356.002)Compliance Program10/17/2022CGMP; Drug Product; Drug Substance/API; ICH; ANDA (generic drugs); NDA (new drugs); Specification and Testing; Microbiology; Excipient/Inactive Ingredient; Compendial Standards; Container Closure/Packaging; Storage and Distribution; lifecycle managamentSterile Drug Process Inspections (7356.002A)Compliance Program9/11/2015NDA (new drugs); ANDA (generic drugs); BLA (biologics); CGMP; Microbiology; Drug Substance/API; Drug Product; Container Closure/PackagingDrug Repackagers and Relabelers (7356.002B)Compliance Program9/11/2015CGMP; Container Closure/Packaging; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Specification and Testing; Compendial StandardsRadioactive Drugs (7356.002C)Compliance Program9/11/2015CGMP; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Specification and Testing; Microbiology; Drug Product; Excipient/Inactive Ingredient; Compendial Standards; Container Closure/PackagingCompressed Medical Gases (7356.002E)Compliance Program3/15/2015CGMPActive Pharmaceutical Ingredient (API) Process Inspection (7356.002F)Compliance Program9/02/2025DMF (drug master files), Drug Substance/API, CGMP, ICH, Administrative/ProceduralSurveillance Inspections of Protein Drug Substance Manufacturers (7356.002M)Compliance Program10/1/2021CGMP; Drug Substance/API; ICH; BLA (biologics); Container Closure/Packaging; Specification and Testing; Microbiology; Excipient/Inactive Ingredient; lifecycle managamentPositron Emission Tomography (PET) CGMP Drug Process and Pre-Approval Inspections/Investigations (7356.002P)Compliance Program9/11/2015Drug Product; Specificaton and Testing; CGMP; Drug Substance/API; IND (investigational new drugs); ANDA (generic drugs); NDA (new drugs); Container Closure/Packaging; Microbiology; Compendial Standards; Storage and Distribution; lifecycle managamentDrug Quality Sampling and Testing (DQST)—Human Drugs (7356.008)Compliance Program9/11/2015Drug Product; Specification and Testing; CGMP; Drug Substance/API; ANDA (generic drugs); NDA (new drugs); Microbiology; Compendial StandardsDrug Quality Reporting System (DQRS) (MedWatch Reports); NDA Field Alert Reports (FARs) (7356.021)Compliance Program9/11/2015Drug Product; Specification and Testing; Drug Substance/API; ANDA (generic drugs); NDA (new drugs); Microbiology; Compendial StandardsPostapproval Inspections (7356.843)Compliance Program3/13/2023NDA (new drugs); ANDA (generic drugs); DMF (drug master files); Drug Product; Drug Substance/API; CGMP; Lifecycle Management; Specification and Testing; Storage and DistributionMAPP 5021.2 Evaluating Color Additives and Flavors Intended for Oral Drug Products Submitted or Referenced in INDs and NDAsMAPP6/21/2023NDA (new drugs); IND (investigational new drugs); DMF (drug master files); Drug Product; Excipient/Inactive IngredientMAPP 5016.3 Rev. 1 Responsibility for the Quality Assessment of Products Containing Peptide or Protein Drug SubstancesMAPP6/21/2023NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs); Drug Substance/API; Drug Product; Excipient/Inactive IngredientMAPP 5021.1 Rev. 1 Naming of Drug Products Containing Salt Drug SubstancesMAPP12/2/2022NDA (new drugs); ANDA (generic drugs); IND (investigational new drugs); Drug Substance/API; Drug Product; Container Closure/PackagingMAPP 5001.1 Drug Product Distribution After a Complete Response Action to a Changes Being Effected SupplementMAPP11/23/2022NDA (new drugs); ANDA (generic drugs); BLA (biologics); Drug Substance/API; Drug Product; Lifecycle ManagementMAPP 5040.1 Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q)MAPP12/7/2022NDA (new drugs); ANDA (generic drugs); BLA (biologics); Drug Product; Container Closure/Packaging; Specification and Testing; Storage and Distribution; Drug Substance/API; Microbiology; ICH; Administrative/ProceduralMAPP 5210.9 Rev. 1 Review of Botanical Drug ProductsMAPP12/30/2016NDA (new drugs); IND (investigational new drugs); Drug Substance/API; Drug Product; Lifecycle Management; Specification and Testing; Biopharmaceutics; MicrobiologyMAPP 5019.1 Rev. 1 Allowable Excess Volume/Content in Injectable Drug and Biological ProductsMAPP1/28/2022NDA (new drugs); ANDA (generic drugs); IND (investigational new drugs); BLA (biologics); Drug Product; Container Closure/PackagingMAPP 5017.1 Rev. 1 Office of Biotechnology Products and Office of Pharmaceutical Manufacturing Assessment, Interactions on BLA AssessmentsMAPP12/2/2022BLA (biologics); IND (investigational new drugs); Drug Substance/API; Drug Product; Specification and Testing; Administrative/ProceduralMAPP 5015.8 Acceptance Criteria for Residual SolventsMAPP12/1/2022Drug Substance/API; Drug Product; Specification and Testing; Excipient/Inactive Ingredient; ICHMAPP 5018.2 NDA Classification CodesMAPP12/08/2022Drug Product; IND (investigational new drugs); NDA (new drugs); Drug Substance/API; Administrative/ProceduralMAPP 5016.6 Change in Hard Gelatin Capsule SupplierMAPP2/21/2023NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Compendial StandardsMAPP 5016.1 Applying ICH Q8(R2), Q9, and Q10 Principles to Chemistry, Manufacturing, and Controls ReviewMAPP5/18/2016ICH; NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs); Drug Substance/API; Drug Product; Excipient/Inactive Ingredient; Lifecycle ManagementMAPP 5310.3 Rev. 2 Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls ChangesMAPP4/8/2021NDA (new drugs); ANDA (generic drugs); BLA (biologics); Drug Product; Lifecycle Management; Public Health EmergencyMAPP 5015.5 Rev. 1 CMC Reviews of Type III DMFs for Packaging MaterialsMAPP12/9/2022DMF (drug master files); Compendial Standards; Lifecycle Management; Drug Substance/API; Drug Product; Container Closure/Packaging; Specification and Testing; NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs)MAPP 5022.0 CDER Liaisons to Official Compendia and Standards Development Organizations – Selection Process, Roles, and ResponsibilitiesMAPP12/7/2022Compendial Standards; Administrative/ProceduralMAPP 5015.7 Rev. 1 Environmental Assessments and Claims of Categorical ExclusionMAPP11/23/2022Lifecycle Management; Drug Substance/API; IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); BLA (biologics)MAPP 5014.1 Rev. 1 Understanding CDER's Risk-Based Site Selection ModelMAPP6/26/2023CGMP; Drug Substance/API; Drug ProductMAPP 5015.6 Rev. 1 Review of Grouped Product Quality SupplementsMAPP12/9/2022Lifecycle Management; NDA (new drugs); ANDA (generic drugs); BLA (biologics)MAPP 5040.1 Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q)MAPP12/7/2022Microbiology; Specification and Testing; ANDA (generic drugs); BLA (biologics); ICH; Container Closure/Packaging; Lifecyle Management; NDA (new drugs); Drug Substance/API; Storage and DistributionMAPP 5310.7 Rev 1 Acceptability of Standards from Alternative Compendia (BP/EP/JP)MAPP12/8/2022Excipient/Inactive Ingredient; Drug Substance/API; Drug Product; IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); Specification and Testing; Compendial StandardsMAPP 5017.4 Quality Center for Drug Evaluation and Research Biopharmaceutics CouncilMAPP5/16/2019Excipient/Inactive Ingredient; Drug Product; Biopharmaceutics; IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs)MAPP 5019.2 Assessment of the Appropriate Net Container Content for Injectable Drug and Biological ProductsMAPP6/6/2022NDA (new drugs); BLA (biologics); Drug Product; ANDA (generic drugs); IND (investigational new drugs); Container Closure/PackagingMAPP 5015.12 Process for Evaluating Emerging Technologies Related to QualityMAPP12/1/2022IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); BLA (biologics); DMF (drug master files); emerging/advanced techMAPP 5015.13 Quality Assessment for Products in Expedited ProgramsMAPP12/7/2022NDA (new drugs); BLA (biologics); IND (investigational new drugs); Drug Product; Drug Substance/API; Public Health Emergency; Specification and Testing; Storage and Distribution; Container Closure/Packaging; CGMPChanges to an Approved NDA or ANDA Guidance4/8/2004ANDA (generic drugs); NDA (new drugs); Lifecycle Management; CGMP; Container Closure/PacakgingChanges to an Approved NDA or ANDA: Questions and AnswersGuidance1/1/2001NDA (new drugs); ANDA (generic drugs); Lifecycle ManagementChanges to an Approved NDA or ANDA; Specifications—Use of Enforcement Discretion for Compendial Changes Guidance11/22/2004NDA (new drugs); ANDA (generic drugs); Lifecycle ManagementChanges to Disposable Manufacturing Materials: Questions and AnswersGuidance7/29/2022BLA (biologics); Lifecycle Management; CGMP; NDA (new drugs); ANDA (generic drugs); Container Closure/PackingChild-Resistant Packaging Statements in Drug Product LabelingGuidance8/13/2019Container Closure/Packaging; Drug Product; Administrative/Procedural; NDA (new drugs); ANDA (generic drugs); BLA (biologics)Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference ProductGuidance12/29/2016BLA (biologics); Specification and TestingCMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports Guidance12/9/2021BLA (biologics); Administrative/ProceduralCMC Postapproval Manufacturing Changes To Be Documented in Annual Reports Guidance3/5/2014ANDA (generic drugs); NDA (new drugs); Container Closure/Packaging; Lifecycle Management; Specification and Testing; Drug ProductComparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLAGuidance10/13/2022NDA (new drugs); ANDA (generic drugs); BLA (biologics); DMF (drug master files); Lifecycle Management; Drug Product; Drug Substance/API; CGMP; Container Closure/Packaging; Specification and TestingCompleteness Assessments for Type II API DMFs Under GDUFAGuidance10/11/2017ANDA (generic drugs); Drug Substance/API; Administrative/ProceduralConsiderations in Demonstrating Interchangeability With a Reference ProductGuidance5/10/2019BLA (biologics); Lifecycle Management; Container Closure/Packaging; Specification and TestingContainer and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile ProductsGuidance2/25/2009Container Closure/Packaging; Specification and Testing; CGMP; Drug ProductContainer Closure Systems for Packaging Human Drugs and BiologicsGuidance7/7/1999Drug Product; Drug Substance/API; CGMP; Container Closure/Packaging; Drug Product; DMF (drug master files)Container Closure Systems for Packaging Human Drugs and Biologics: Questions and AnswersGuidance5/1/2002Drug Product; Container Closure/Packaging; BLA (biologics); CGMPContract Manufacturing Arrangements for Drugs: Quality AgreementsGuidance11/23/2016CGMP; Storage and Distribution; Administrative/Procedural; Specification and TestingControl of Nitrosamine Impurities in Human DrugsGuidance9/5/2024NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs); DMF (drug master files); Drug Product; CGMP; Lifecycle Management; Specification and Testing; BiopharmaceuticsCooperative Manufacturing Arrangements for Licensed BiologicsGuidance2/24/2021BLA (biologics); CGMP; Container Closure/Packaging; Specification and Testing; Lifecycle Management; Storage and DistributionCOVID-19 Container Closure System and Component Changes: Glass Vials and StoppersGuidance3/4/2021Public Health Emergency; Container Closure/Packaging; ANDA (generic drugs); BLA (biologics); NDA (new drugs); Specification and Testing; Compendial Standards; Drug ProductCurrent Good Manufacturing Practice for Medical Gases Guidance6/29/2017CGMP; Specification and Testing; Administrative/ProceduralCurrent Good Manufacturing Practice Requirements for Combination ProductsGuidance1/11/2017Drug Substance/API; Drug Product; CGMP; Container Closure/Packaging; Specification and Testing; Storage and Distribution; MicrobiologyCurrent Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C ActGuidance1/22/2020CGMP; Compounding; Drug Substance/API; Drug Product; Specification and Testing; MicrobiologyData Integrity and Compliance With Drug CGMP Questions and AnswersGuidance12/13/2018CGMP; Compounding; Drug Substance/API; Drug Product; Specification and Testing; MicrobiologyDemonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived ProductsGuidance4/1/1996BLA (biologics); CGMP; Specification and TestingAlternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending ApplicationsGuidance9/22/2023NDA (new drugs); ANDA (generics); BLA (biologics); CGMP; public health emergencyQuality Considerations for Topical Ophthalmic Drug ProductsGuidance12/28/2023NDA (new drugs); ANDA (generics); BLA (biologics); Drug Product; Specification and Testing; Container Closure/Packaging; Compendial StandardsMAPP 5021.5 Assessment of Facility-Based Deficiency Major-to-Minor Reclassification RequestsMAPP1/15/2024ANDA (generics); Administrative/Procedural; CGMPMAPP 5016.8 Using Four-Part Harmony in Quality-Related Assessment CommunicationsMAPP9/22/2023Administrative/Procedural; Lifecycle Management; IND (investigational new drugs); NDA (new drugs); ANDA (generics); BLA (biologics); DMF (drug master files)MAPP 5017.8 Responsibilities for the Assessment of In Vitro Testing for Oral Drug Products Administered Via Enteral Feeding TubeMAPP9/5/2023Drug Product; IND (investigational new drugs); NDA (new drugs); ANDA (generics); Specification and Testing; BiopharmaceuticsGood ANDA Submission PracticesGuidance1/26/2022ANDA (generics); Drug Product; Drug Substance/API; Biopharmaceutics; Microbiology; CGMP; Administrative/Procedural; DMF (drug master files); Specification and TestingMAPP 5241.3 Rev. 1 Good Abbreviated New Drug Application Assessment PracticesMAPP10/6/2023ANDA (generics); Administrative/Procedural; Drug Product