EUROLAB
usp-1078-good-manufacturing-practices-for-bulk-excipients
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XII G: Total Aerobic Microbial Count in LiquidsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.14 Microbiological Integrity Testing for PackagingEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1047> Testing for Biotechnological Protein ProductsUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1079> Good Storage and Shipping Practices for Drug ProductsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <1216> Tablet Friability TestingUSP <121> Sterilization Assurance Level TestingUSP <1224> Transfer of Analytical ProceduresUSP <1225> Validation of Analytical ProceduresUSP <1226> Verification of Compendial ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <467> Residual Solvents Testing in Drug SubstancesUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

USP <1078> Good Manufacturing Practices for Bulk Excipients Laboratory Testing Service Provided by Eurolab

The USP <1078> Good Manufacturing Practices for Bulk Excipients is a comprehensive standard that outlines the requirements for the testing and evaluation of bulk excipients used in pharmaceutical manufacturing. This standard is widely accepted and implemented globally, ensuring consistency and reliability in the production of high-quality bulk excipients.

Relevant Standards

The following standards are relevant to USP <1078> Good Manufacturing Practices for Bulk Excipients:

  • ISO 9001:2015 (Quality Management System)

  • ASTM E1559-15 (Standard Practice for Conducting Interlaboratory Studies)

  • EN 13427:2004 (Pharmaceutical excipients - Terminology and classification)

  • TSE 2306:2012 (Pharmaceutical excipients - Testing of bulk excipients)

  • USP <1058> (Dissolution)

    • Legal and Regulatory Framework

    The testing and evaluation of bulk excipients are governed by various laws and regulations, including:

  • The Food and Drug Administrations (FDA) Good Manufacturing Practice (GMP) regulations

  • The European Medicines Agencys (EMA) GMP guidelines

  • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

  • National and international regulations specific to the country or region

    • International and National Standards

    The following standards apply internationally:

  • ISO 9001:2015

  • ASTM E1559-15

  • EN 13427:2004

    • National standards may vary depending on the country. For example, in the United States, the FDA regulations govern GMP requirements for bulk excipients.

    Standard Development Organizations

    The following organizations are involved in standard development:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations work together to develop, publish, and update standards that ensure consistency and reliability in the production of bulk excipients.

    Standard Evolution and Updates

    Standards evolve over time as new technologies, methods, and practices emerge. Regular updates are necessary to reflect changes in industry requirements and regulatory expectations.

    Specific Standard Numbers and Scope

    The following standard numbers and scope apply to USP <1078> Good Manufacturing Practices for Bulk Excipients:

  • ISO 9001:2015 - Quality Management System

    • Scope: Requirements for a quality management system (QMS)

  • ASTM E1559-15 - Standard Practice for Conducting Interlaboratory Studies

    • Scope: Guidelines for conducting interlaboratory studies to ensure consistency and reliability

  • EN 13427:2004 - Pharmaceutical excipients - Terminology and classification

    • Scope: Classification and terminology of pharmaceutical excipients

  • TSE 2306:2012 - Pharmaceutical excipients - Testing of bulk excipients

    • Scope: Testing requirements for bulk excipients

    Industry-Specific Examples and Case Studies

    The following examples illustrate the importance of USP <1078> Good Manufacturing Practices for Bulk Excipients:

  • A pharmaceutical company uses a bulk excipient that fails to meet the required specifications. The consequences include product recall, financial losses, and damage to reputation.

  • A contract manufacturer is audited by a regulatory agency and found non-compliant with GMP requirements. The consequences include fines, penalties, and loss of business.

    • Standard Compliance Requirements for Different Industries

    Compliance with USP <1078> Good Manufacturing Practices for Bulk Excipients is required for:

  • Pharmaceutical manufacturers

  • Contract manufacturers

  • API (Active Pharmaceutical Ingredient) manufacturers

  • Food and beverage industry

  • Cosmetics and personal care industry

    • ---

    The following section explains the need and requirements for USP <1078> Good Manufacturing Practices for Bulk Excipients:

    Why This Test is Needed

    Bulk excipients play a critical role in pharmaceutical manufacturing. The quality of bulk excipients directly affects product performance, safety, and efficacy.

    Business and Technical Reasons

    Conducting testing and evaluation on bulk excipients ensures:

  • Product safety and reliability

  • Compliance with regulatory requirements

  • Quality assurance and control

  • Risk assessment and mitigation

  • Cost savings through efficient production processes

    • Consequences of Not Performing This Test

    Not performing the test can lead to:

  • Product recall

  • Financial losses

  • Damage to reputation

  • Regulatory penalties

    • Industries and Sectors That Require This Testing

    The following industries require testing and evaluation on bulk excipients:

  • Pharmaceutical manufacturers

  • Contract manufacturers

  • API (Active Pharmaceutical Ingredient) manufacturers

  • Food and beverage industry

  • Cosmetics and personal care industry

    • Risk Factors and Safety Implications

    The risk factors associated with non-compliant or defective bulk excipients include:

  • Product contamination

  • Inadequate product performance

  • Patient safety risks

  • Regulatory penalties

    • Quality Assurance and Control

    Ensuring the quality of bulk excipients is crucial for maintaining a GMP compliant operation. This includes regular testing, calibration, and validation.

    ---

    The USP <1078> Good Manufacturing Practices for Bulk Excipients is a comprehensive standard that outlines the requirements for the testing and evaluation of bulk excipients used in pharmaceutical manufacturing. This standard is widely accepted and implemented globally, ensuring consistency and reliability in the production of high-quality bulk excipients.

    Relevant Standards

    The following standards are relevant to USP <1078> Good Manufacturing Practices for Bulk Excipients:

  • ISO 9001:2015 (Quality Management System)

  • ASTM E1559-15 (Standard Practice for Conducting Interlaboratory Studies)

  • EN 13427:2004 (Pharmaceutical excipients - Terminology and classification)

  • TSE 2306:2012 (Pharmaceutical excipients - Testing of bulk excipients)

  • USP <1058> (Dissolution)

    • Standard Evolution and Updates

    Standards evolve over time as new technologies, methods, and practices emerge. Regular updates are necessary to reflect changes in industry requirements and regulatory expectations.

    Specific Standard Numbers and Scope

    The following standard numbers and scope apply to USP <1078> Good Manufacturing Practices for Bulk Excipients:

  • ISO 9001:2015 - Quality Management System

    • Scope: Requirements for a quality management system (QMS)

  • ASTM E1559-15 - Standard Practice for Conducting Interlaboratory Studies

    • Scope: Guidelines for conducting interlaboratory studies to ensure consistency and reliability

  • EN 13427:2004 - Pharmaceutical excipients - Terminology and classification

    • Scope: Classification and terminology of pharmaceutical excipients

  • TSE 2306:2012 - Pharmaceutical excipients - Testing of bulk excipients

    • Scope: Testing requirements for bulk excipients

    Industry-Specific Examples and Case Studies

    The following examples illustrate the importance of USP <1078> Good Manufacturing Practices for Bulk Excipients:

  • A pharmaceutical company uses a bulk excipient that fails to meet the required specifications. The consequences include product recall, financial losses, and damage to reputation.

  • A contract manufacturer is audited by a regulatory agency and found non-compliant with GMP requirements. The consequences include fines, penalties, and loss of business.

    • Standard Compliance Requirements for Different Industries

    Compliance with USP <1078> Good Manufacturing Practices for Bulk Excipients is required for:

  • Pharmaceutical manufacturers

  • Contract manufacturers

  • API (Active Pharmaceutical Ingredient) manufacturers

  • Food and beverage industry

  • Cosmetics and personal care industry

    • ---

    The following section explains the need and requirements for USP <1078> Good Manufacturing Practices for Bulk Excipients:

    Why This Test is Needed

    Bulk excipients play a critical role in pharmaceutical manufacturing. The quality of bulk excipients directly affects product performance, safety, and efficacy.

    Business and Technical Reasons

    Conducting testing and evaluation on bulk excipients ensures:

  • Product safety and reliability

  • Compliance with regulatory requirements

  • Quality assurance and control

  • Risk assessment and mitigation

  • Cost savings through efficient production processes

    • Consequences of Not Performing This Test

    Not performing the test can lead to:

  • Product recall

  • Financial losses

  • Damage to reputation

  • Regulatory penalties

    • Industries and Sectors That Require This Testing

    The following industries require testing and evaluation on bulk excipients:

  • Pharmaceutical manufacturers

  • Contract manufacturers

  • API (Active Pharmaceutical Ingredient) manufacturers

  • Food and beverage industry

  • Cosmetics and personal care industry

    • Risk Factors and Safety Implications

    The risk factors associated with non-compliant or defective bulk excipients include:

  • Product contamination

  • Inadequate product performance

  • Patient safety risks

  • Regulatory penalties

    • Quality Assurance and Control

    Ensuring the quality of bulk excipients is crucial for maintaining a GMP compliant operation. This includes regular testing, calibration, and validation.

    ---

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