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    The Top 70 Microbiology Regulations

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    Rudra Rahman
    This document provides a list of 70 global regulatory requirements and recommendations for microbiology in pharmaceutical and medical device manufacturing. The list includes regulations from the US FDA, USP, PDA, EMA, ICH, ISO, Japan Pharmacopeia, MHRA, and WHO that cover topics like microbiological testing, sterilization, cleanrooms, and more. Knowledge of these regulations is essential for companies pursuing global regulatory compliance in microbiology. The document recommends several authors and resources for additional information on microbiological best practices.

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    The Top 70 Microbiology Regulations

    Uploaded by

    Rudra Rahman
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    This document provides a list of 70 global regulatory requirements and recommendations for microbiology in pharmaceutical and medical device manufacturing. The list includes regulations from the US FDA, USP, PDA, EMA, ICH, ISO, Japan Pharmacopeia, MHRA, and WHO that cover topics like microbiological testing, sterilization, cleanrooms, and more. Knowledge of these regulations is essential for companies pursuing global regulatory compliance in microbiology. The document recommends several authors and resources for additional information on microbiological best practices.

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    Best collection of Microbiology Regulation from IVT

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    This document provides a list of 70 global regulatory requirements and recommendations for microbiology in pharmaceutical and medical device manufacturing. The list includes regulations from the US FDA, USP, PDA, EMA, ICH, ISO, Japan Pharmacopeia, MHRA, and WHO that cover topics like microbiological testing, sterilization, cleanrooms, and more. Knowledge of these regulations is essential for companies pursuing global regulatory compliance in microbiology. The document recommends several authors and resources for additional information on microbiological best practices.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    95 views3 pages

    The Top 70 Microbiology Regulations

    Uploaded by

    Rudra Rahman
    This document provides a list of 70 global regulatory requirements and recommendations for microbiology in pharmaceutical and medical device manufacturing. The list includes regulations from the US FDA, USP, PDA, EMA, ICH, ISO, Japan Pharmacopeia, MHRA, and WHO that cover topics like microbiological testing, sterilization, cleanrooms, and more. Knowledge of these regulations is essential for companies pursuing global regulatory compliance in microbiology. The document recommends several authors and resources for additional information on microbiological best practices.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 3

    Published on IVT Network (http://www.ivtnetwork.

    com)

    The Top 70 Microbiology Regulations

    Jun 10, 2014 2:07 pm EDT

    Microbiology and microbiological processes have are some of the mostly widely regulated and scrutinized activities in
    pharmaceutical and medical device manufacturing. Recently, rapid microbiological methods, good compounding practice,
    the use of biological indicators, and increased depth of FDA inspections have created an atmosphere where knowledge of
    regulatory guidance is an essential aspect of business operations. Taken from IVT's Microbiology Week, the following is a
    robust list of global regulatory requirements and recommendations that need to be reviewed as companies pursue global
    compliance.

    Editor's note: There is a wide variety of media and other resources available for microbiologists in GXP-regulated industries.
    While there are too many to count here, some of IVT's favorites are pieces fromTim Sandle,Scott Sutton, andJeanne
    Moldenhauer as well as information from thePharmaceutical Microbiology Forum.

    US Food and Drug Administration


    1. Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production, read it here.
    2. Code of Federal Regulations Title 21 Part 211 (specifically, 211.84, 211.113(a), 211.165(b), 211.94, 211.46, 211.56,
    211.113), read it here.
    3. Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice, read it here.
    4. Pyrogen and Endotoxins Testing: Questions and Answers, read it here.
    5. Bad Bug Book, read it here.
    6. Proposal to amend the sterility test requirements for biological products
    7. Amendments to Sterility Test Requirements for Biological Products, read it here.
    8. 21 CFR Part 820.70, read it here.
    9. 21 CFR 610.12, read it here.

    Center for Disease Control


    10. Biosafety in Microbiological and Biomedical Laboratories, read it here.

    American Public Health Association


    11. “Standard Methods for the Examination of Water and Wastewater, read it here.

    United States Pharmacopeia


    12. USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments, read it here.
    13. USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests, read it here.
    14. USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms, read it here.
    15. USP <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations
    and Substances for Pharmaceutical Use
    16. USP <1112> Application of Water Activity Determination To Nonsterile Pharmaceutical Products
    17. USP <1223> Validation of Alternative Microbiological Methods
    18. USP <1115> Bioburden Control for Nonsterile Substances and Products
    19. USP <1231> Water for Pharmaceutical Purposes
    20. USP <1117> Microbiological Best Laboratory Practices
    21. USP <1227> Validation of Microbial Recovery from Pharmacopeial Articles
    22. USP <85> Bacterial Endotoxins Test, read it here.
    23. USP <151> Pyrogen Test
    24. USP <1113> Microbial Characterization, Identification and Strain Typing
    25. USP <71> Sterility Tests
    26. USP <1035> Biological Indicators for Sterilization
    27. USP <55> Biological Indicators – Resistance Performance Tests, read it here.
    28. USP <51> Antimicrobial Effectiveness Testing
    29. Biological Indicator for Steam Sterilization, Paper Carrier
    30. Biological Indicator for Dry?Heat Sterilization, Paper Carrier
    31. Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier
    32. Biological Indicator for Steam Sterilization, Self?Contained
    33. Biological Indicators for Moist Heat, Dry Heat, and Gaseous Modes of Sterilization, Nonpaper Carriers
    34. Biological Indicators for Moist Heat, Dry Heat, and Gaseous Modes of Sterilization, Liquid Spore Suspensions
    35. USP <1211> Sterilization and Sterility Assurance of Compendial Articles
    36. USP <1229> Sterilization of Compendial Articles
    37. USP <1035> Sterilization and Sterility Assurance of Compendial Articles
    38. USP <797> Pharmaceutical Compounding—Sterilization Preparations, read it here.
    39. USP <1207> Sterile Product Packaging?Integrity Evaluation
    40. USP <1113> Microbial Identification
    41. USP <1046> Cell and Gene Therapy Products

    Parenteral Drug Association


    42. “Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control,”
    PDA Technical Report No. 1
    43. “Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance,” PDA Technical
    Report No. 48, read it here.
    44. “Validation of Dry Heat Processes Used for Sterilization and Depyrogenation,” PDA Technical Monograph No. 3
    45. “The Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing Methods,” PDA
    Technical Report No. 33
    46. “Steam In Place,” PDA Technical Report No. 61
    47. “Pharmaceutical Package Integrity Testing,” PDA Technical Report No. 27
    48. “Process Validation: A Lifecycle Approach,” PDA Technical Report No. 60
    49. “Points to Consider for Cleaning Validation,” PDA Technical Report No. 29
    50. “Fundamentals of an Environmental Monitoring Program,” PDA Technical Report No. 13

    European Pharmacopeia
    51. EP 2.6.12. Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests
    52. EP 2.6.13. Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms
    53. EP 5.1.6 Alternative methods for control of microbial quality

    European Medicines Agency


    54. Concept paper on revision of Annex 15 of the GMP guide, read it here.
    55. Eudralex Volume 4 Good manufacturing practices, Annex 17 Parametric Release, read it here.
    56. Draft Guideline on Quality of Transdermal Patches, read it here.
    57. Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues,
    read it here.
    58. Guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use, read it here.

    International Conference for Harmonisation


    59. ICH Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions, read it here and
    Annex Q4A(RI), Annex Q4B(R1), Annex 4C(R1), Annex 8(R1).
    60. ICH Q6A Specifications: Test Procedures for New Drug Substances and New Drug Products: Chemical Substances,
    read it here.
    61. ICH Q2(R1) Tripartite Guideline: Validation of Analytical Procedures: Text and Methodology, read it here.
    62. ICH Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, read it here.

    International Organization for Standardization


    63. ISO 14644 Series Standards for Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones
    64. AAMI/ISO 11737, Sterilization of health care products—Microbiological methods, read it here.
    65. ISO 14698 Cleanrooms and associated controlled environments -- Biocontamination control, read it here.

    Japan Pharmacopeia
    66. 4.05 Microbiological Examination of Non-sterile Products, read it here.

    Medicines and Healthcare products Regulatory Agency


    67. Out of specification (OOS) FAQs, read it here.
    68. Rules and Guidance for Pharmaceutical Manufacturers and Distributors, read it here.

    World Health Organization


    69. WHO Guidelines on the Quality, Safety, and Efficacy of Biotherapeutic Products Prepared by Recombinant DNA
    Technology, read it here.
    70. Good Practices for pharmaceutical microbiology laboratories, read it here.

    Source URL: http://www.ivtnetwork.com/article/top-70-microbiology-regulations

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