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usp-61-microbial-enumeration-tests-for-raw-pharmaceutical-materials
Pharmaceutical Microbiology Testing ICH Q10 Pharmaceutical Quality System and Microbial ControlsICH Q6A Testing for Microbiological Attributes of Drug SubstancesICH Q7 GMP Guidelines for Microbial Control in APIsICH Q9 Risk-Based Approach to Microbial ContaminationISO 11737-1 Bioburden Testing for Medical Devices and Pharmaceutical PackagingISO 11737-2 Sterility Assurance and Validation for Pharmaceutical ComponentsISO 11930 Preservation Efficacy Testing for Topical PharmaceuticalsISO 14644-1 Cleanroom Classification for Pharmaceutical ManufacturingISO 14698-1 Biocontamination Control in CleanroomsISO 16212 Yeast and Mold Testing in Pharmaceutical Raw MaterialsISO 18415 Detection of Pathogenic Microorganisms in Non-Sterile ProductsISO 21149 Enumeration of Aerobic Mesophilic Bacteria in Cosmetic and PharmaJP XVII Bacterial Endotoxin Test for Injectable PharmaceuticalsJP XVII Microbial Limit Tests for Oral PreparationsJP XVII Sterility Test for Pharmaceutical ProductsPh. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical ProductsPh. Eur. 2.6.11 Detection of Pathogens in Veterinary PharmaceuticalsPh. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile ProductsPh. Eur. 2.6.13 Detection of Clostridia in Parenteral SolutionsPh. Eur. 2.6.14 Bacterial Endotoxins – Gel Clot MethodPh. Eur. 2.6.15 Test for Pseudomonas aeruginosa in Topical DrugsPh. Eur. 2.6.16 Test for Staphylococcus aureus in Creams and GelsPh. Eur. 2.6.2 Mycoplasma Detection in Cell-Based PharmaceuticalsPh. Eur. 2.6.25 Testing for Anaerobic Bacteria in Sterile ProductsPh. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral DrugsPh. Eur. 2.6.30 Monitoring of Controlled EnvironmentsPh. Eur. 2.6.32 Control of Bacterial Contamination in Ophthalmic DrugsPh. Eur. 2.6.7 Mycobacteria Detection in BiopharmaceuticalsPh. Eur. 2.6.9 Test for Escherichia coli in Non-Sterile PharmaPh. Eur. 5.1.4 Microbiological Quality of Pharmaceutical PreparationsPh. Eur. 5.1.6 Alternative Methods for Microbiological Quality ControlPh. Eur. 5.1.8 Bioburden Limits in Parenteral ManufacturingUSP <1072> Disinfectants and Antiseptics Microbial Efficacy TestUSP <1111> Microbiological Examination of Non-Sterile ProductsUSP <1115> Bioburden Control of Non-Sterile Drug SubstancesUSP <1116> Microbiological Control of Clean Rooms and Controlled EnvironmentsUSP <1117> Microbial Best Practices for Pharmaceutical Lab PersonnelUSP <1207> Package Integrity Evaluation – Microbial Ingress TestUSP <1208> Integrity Testing for Sterile Barrier SystemsUSP <1223> Water Activity Determination in Drug ProductsUSP <1227> Validation of Microbial Recovery MethodsUSP <1229> Microbial Quality of Compendial Water SystemsUSP <1231> Water for Pharmaceutical Purposes – Microbiological TestingUSP <39> Bioburden Limit Testing for Bulk Active IngredientsUSP <39> Microbiological Quality of Compounding PharmaciesUSP <51> Preservative Effectiveness Testing of Multi-Dose PharmaceuticalsUSP <55> Biological Indicators for Sterilization ValidationUSP <61>/<62> Microbial Limit Tests for Tablet and Capsule FormsUSP <62> Tests for Specified Microorganisms in Non-Sterile ProductsUSP <71> Sterility Testing of Injectable Pharmaceutical Products

USP <61> Microbial Enumeration Tests for Raw Pharmaceutical Materials: Laboratory Testing Services

The United States Pharmacopeia (USP) <61> Microbial Enumeration Tests for Raw Pharmaceutical Materials is a critical laboratory testing service that ensures the quality and safety of raw pharmaceutical materials. This section provides comprehensive information about the relevant standards, regulatory framework, standard development organizations, and compliance requirements.

International Standards

  • ISO 21528-1:2017 - Water Quality - Detection and enumeration of microorganisms in water intended for human consumption - Part 1: General rules

  • ASTM E1174-19 - Standard Practice for Estimation of Microbial Counts from Environmental Swab Sampling

  • EN 12312-1:2006 - Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods

    • National Standards

  • USP <61> Microbial Enumeration Tests for Raw Pharmaceutical Materials

  • FDAs Current Good Manufacturing Practice (CGMP) regulations, 21 CFR Part 211

  • EU GMP Annex 1, Cleanrooms and clean air devices

    • Standard Development Organizations

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Regulatory Framework

    The regulatory framework surrounding USP <61> Microbial Enumeration Tests for Raw Pharmaceutical Materials is governed by international, national, and industry-specific standards. Compliance with these standards ensures the quality and safety of raw pharmaceutical materials.

    Industry-Specific Standards

  • ISO 14644-1:2015 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

  • USP <111> Sterility Tests for Pharmaceuticals

  • ASTM E2424-19 - Standard Guide for Development of Microbiological Control Strategies

    • Compliance Requirements

    Compliance with these standards is mandatory for industries involved in the production and processing of pharmaceuticals, including:

  • Pharmaceutical manufacturers

  • Contract manufacturers

  • Distributors and wholesalers

  • Regulatory agencies

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