EUROLAB
usp-797-sterile-compounding-and-impurity-control
Impurity Profiling EMA Guideline on Genotoxic Impurities in PharmaceuticalsEMA Reflection Paper on Low Level ImpuritiesFDA Guidance: Microbial Impurities and Endotoxin LevelsFDA Guidance: Threshold of Toxicological Concern (TTC) for ImpuritiesFDA ICH M3(R2): Impurities in Safety StudiesFDA Q&A on Impurities in Generic Drug ApplicationsFDA Q&A: Managing Impurities in Complex APIsICH E14: QT Interval Evaluation and Impurity ImpactICH M7: Mutagenic Impurity Risk AssessmentICH Q10: Pharmaceutical Quality System for Impurity ManagementICH Q11: Impurity Control Strategy in Drug Substance DevelopmentICH Q12: Lifecycle Management of Impurity Control StrategyICH Q1E: Evaluation of Stability Data Related to Impurity FormationICH Q2(R1): Validation of Analytical Methods for Impurity TestingICH Q3A: Organic Impurity Profiling in Drug SubstancesICH Q3B: Impurity Testing in Finished Drug ProductsICH Q3C: Residual Solvent ProfilingICH Q3D: Elemental Impurity Risk AssessmentICH Q3F: Impurity Guidelines for Biotechnology ProductsICH Q4B: Harmonization of Analytical Procedures for Impurity TestingICH Q5C: Impurity Monitoring in Biotechnological ProductsICH Q6A: Specifications and Acceptance Criteria for ImpuritiesICH S3A: Impurities Arising from Degradation ProductsICH S6: Biotech Product Impurity ProfilingICH S7A: Safety Pharmacology Impurity EvaluationICH S9: Impurities in Oncology ProductsISO 10993-18: Chemical Characterization and Impurity AnalysisISO 17025: Accreditation for Impurity Testing LaboratoriesJP General Rule 2.60: Limit Test for ImpuritiesPh. Eur. 2.2.28: Gas Chromatography for Impurity DetectionPh. Eur. 2.2.38: Thin-Layer Chromatography for ImpuritiesPh. Eur. 2.2.46: Chromatographic Separation for Impurity AnalysisPh. Eur. 2.4.14: Determination of Inorganic ImpuritiesPh. Eur. 2.4.20: Limit Test for Heavy Metals in ImpuritiesPh. Eur. 2.4.24: Related Substances by HPLC in APIsPh. Eur. 2.4.29: Limit Test for Sulfated Ash ImpuritiesPh. Eur. 2.5.13: Oxidizing Impurity TestsPh. Eur. 2.9.40: Uniformity of Dosage Units and Related ImpuritiesPh. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical UsePh. Eur. 5.4: Impurities in Radiopharmaceutical PreparationsUSP <1010>: Analytical Data Integrity in Impurity ReportingUSP <1031>: The Biocompatibility of Materials and ImpuritiesUSP <1051>: Cleaning Validation Limits and Residual ImpuritiesUSP <1058>: Analytical Instrument Qualification for Impurity StudiesUSP <1078>: Good Manufacturing Practices for Impurity ReductionUSP <1085>: Evaluation of Impurity Method PerformanceUSP <1086>: Impurities in Drug SubstancesUSP <1088>: Forced Degradation Studies for Impurity CharacterizationUSP <1091>: Impurity Isolation and Characterization TechniquesUSP <1099>: Acceptable Analytical Performance CriteriaUSP <1121>: Bulk Pharmaceutical Chemicals and Impurity HandlingUSP <1151>: Pharmaceutical Dosage Forms and Impurity ConsiderationUSP <1191>: Stability Testing of Compounded PreparationsUSP <1222>: Terminal Sterilization Impact on ImpuritiesUSP <1224>: Transfer of Impurity Test ProceduresUSP <1225>: Validation of Compendial Procedures for ImpuritiesUSP <1226>: Verification of Compendial Procedures for Impurity DetectionUSP <1231>: Water for Pharmaceutical Purposes and Impurity EffectsUSP <1232>: Water Activity and Impurity StabilityUSP <1241>: Capsules and Shell Impurity InteractionUSP <1251>: Weighing on Analytical Balances for Micro-ImpuritiesUSP <161>: Transdermal Delivery Systems and Impurity ControlUSP <197>: Spectrophotometric Identification of ImpuritiesUSP <233>: Elemental Impurities Profiling Using ICP-MSUSP <41>: Balances Used for Impurity Weight DeterminationUSP <466>: Identification and Quantification of DegradantsUSP <467>: Residual Solvent Testing in APIs and ExcipientsUSP <476>: Impurity Profiling for New Drug ApplicationsUSP <621>: Chromatography Conditions for Impurity IdentificationUSP <730>: Plasma Spectrochemistry for Impurity ProfilingUSP <791>: pH Determination Impact on Impurity SolubilityUSP <800>: Hazardous Drug Handling Based on Impurity RiskUSP <851>: Spectrophotometry and Light Scattering for ImpuritiesUSP <853>: Atomic Absorption Spectroscopy for Trace ImpuritiesUSP <857>: UV-Vis Spectroscopy for Impurity QuantificationUSP <85>: Bacterial Endotoxin Limits Related to Impurity SafetyUSP <891>: Nuclear Magnetic Resonance (NMR) for Structural ElucidationUSP <905>: Content Uniformity Related to ImpuritiesUSP <905>: Uniformity of Dosage Units Affected by ImpuritiesUSP <941>: Characterization of Impurity Solubility and pKaWHO TRS 970 Annex 2: Impurity Control in Medicines

USP <797>: Sterile Compounding and Impurity Control Laboratory Testing Service Provided by Eurolab

Understanding the Relevance, Requirements, and Benefits of this Essential Testing Service

USP <797> is a widely recognized standard for sterile compounding and impurity control testing in the pharmaceutical industry. It outlines the requirements for ensuring the quality and safety of compounded preparations. In this section, we will delve into the relevant standards that govern USP <797>: Sterile Compounding and Impurity Control testing.

International Standards

  • ISO 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories

  • ASTM E2500-09 (R2016) - Standard Guide for Establishing Consistent Calibration, Identification, and Labeling Practices for Equipment Used in Laboratories

  • EN ISO 15189:2012 - Medical laboratories Requirements for quality and competence

    • National Standards

  • USP <797> - Pharmaceutical Compounding - Sterile Preparations

  • FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

  • EU GMP Annex 1: Manufacture of Sterile Medicinal Products

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN) are among the prominent standard development organizations that contribute to the evolution of standards in the field of sterile compounding and impurity control testing.

    Evolution of Standards

    Standards evolve as new technologies, research findings, and industry practices emerge. The revision process involves expert committees, stakeholder engagement, and a rigorous review cycle to ensure that updated standards meet the changing needs of industries and regulatory bodies.

    Standard Numbers and Scope

  • ISO 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories

    • Scope: Ensures laboratories maintain their competence through ongoing internal audits and assessments.

  • ASTM E2500-09 (R2016) - Standard Guide for Establishing Consistent Calibration, Identification, and Labeling Practices for Equipment Used in Laboratories

    • Scope: Outlines best practices for equipment calibration, identification, and labeling to ensure accurate testing results.

    Industry-Specific Compliance Requirements

    Compliance with relevant standards is crucial for industries involved in sterile compounding and impurity control testing. Failure to adhere to these standards can result in non-compliance issues, regulatory fines, and compromised product quality.

    The following table highlights the key aspects of standard-related information:

    Standard Scope Relevance to USP <797>: Sterile Compounding and Impurity Control Testing

    --- --- ---

    ISO 17025:2017 General Requirements for Competence of Testing and Calibration Laboratories Essential for laboratory competence assessment

    ASTM E2500-09 (R2016) Standard Guide for Establishing Consistent Calibration, Identification, and Labeling Practices for Equipment Used in Laboratories Critical for equipment calibration, identification, and labeling

    Regulatory bodies worldwide recognize the importance of adhering to standards related to sterile compounding and impurity control testing. Here are a few examples:

  • US FDA: Requires compliance with USP <797> guidelines for sterile preparation.

  • EU GMP Annex 1: Sets forth requirements for manufacturing sterile medicinal products.

    • Maintaining standard compliance is essential to demonstrate adherence to industry best practices and regulatory expectations. The following industries require USP <797>: Sterile Compounding and Impurity Control testing:

  • Pharmaceutical companies

  • Contract testing laboratories

  • Research institutions

  • Government agencies

    • In this section, we will explore the business and technical reasons for conducting USP <797>: Sterile Compounding and Impurity Control testing.

    Why This Test is Needed

    The pharmaceutical industry demands high-quality products that meet stringent safety and efficacy standards. USP <797> provides a framework for ensuring consistent results across laboratories.

    Business and Technical Reasons

  • Ensures product quality and safety

  • Supports regulatory compliance

  • Enhances customer confidence and trust

  • Fosters innovation and research development

    • Consequences of Not Performing This Test

    Failure to conduct this test can lead to:

  • Quality issues and product recalls

  • Regulatory non-compliance and fines

  • Compromised customer trust and loyalty

  • Inability to access international markets due to regulatory hurdles

    • Risk Factors and Safety Implications

    Inadequate testing for impurities in sterile compounded preparations poses significant risks, including:

  • Patient harm or illness from contaminated products

  • Damage to brand reputation and credibility

  • Potential loss of market share due to non-compliance

    • Quality Assurance and Quality Control

    Effective quality assurance and control measures are crucial for ensuring consistent results. This includes maintaining equipment calibration, verifying testing protocols, and adhering to standard operating procedures.

    Here is a summary of the key aspects related to standard requirements and needs:

    Reason Description

    --- ---

    Ensures Product Quality and Safety High-quality products meet stringent safety standards.

    Supports Regulatory Compliance Adheres to industry best practices, regulatory expectations, and relevant standards.

    Enhances Customer Confidence and Trust Demonstrates a commitment to quality, consistency, and safety.

    Regulatory bodies worldwide emphasize the importance of adhering to standard requirements for USP <797>: Sterile Compounding and Impurity Control testing.

  • FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

  • EU GMP Annex 1: Manufacture of Sterile Medicinal Products

    • Maintaining standard compliance is essential to demonstrate adherence to industry best practices and regulatory expectations. The following industries require USP <797>: Sterile Compounding and Impurity Control testing:

  • Pharmaceutical companies

  • Contract testing laboratories

  • Research institutions

  • Government agencies

    • Here are a few examples of standard-related information:

    Standard Scope Relevance to USP <797>: Sterile Compounding and Impurity Control Testing

    --- --- ---

    ...

    (Insert remaining sections)

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers