EUROLAB
ich-q10-pharmaceutical-quality-system-and-microbial-controls
Pharmaceutical Microbiology Testing ICH 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> Microbial Enumeration Tests for Raw Pharmaceutical MaterialsUSP <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

ICH Q10 Pharmaceutical Quality System and Microbial Controls Laboratory Testing Service Provided by Eurolab

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global regulatory organization that develops guidelines and standards for pharmaceutical development, manufacturing, and testing. ICH Q10 Pharmaceutical Quality System is one such guideline that aims to provide a framework for the development and implementation of a robust quality management system in pharmaceutical companies.

The ICH Q10 Pharmaceutical Quality System standard is based on various international standards, including ISO 9001:2015 (Quality Management Systems - Requirements), ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes), and EN ISO/IEC 17025:2018 (General requirements for the competence of testing and calibration laboratories). These standards provide a foundation for ensuring that pharmaceutical companies develop and implement effective quality management systems to ensure the safety, efficacy, and quality of their products.

In addition to ICH Q10, Eurolab also provides laboratory testing services in accordance with various other international standards, including:

  • ISO 11133:2014 (Microbiology of food and animal feeding stuffs - Guidelines on preparation and production of culture media)

  • ASTM E2536-17 (Standard Practice for Microbial Testing of Pharmaceutical Products)

  • EN 14698:2009 (Water quality - Detection of Pseudomonas aeruginosa - Part 1: Presence/absence method)

    • Eurolabs laboratory testing services are designed to ensure that pharmaceutical companies comply with regulatory requirements and industry standards, including ICH Q10. Our team of experts has extensive knowledge and experience in conducting microbial controls testing for various pharmaceutical products.

    The legal and regulatory framework surrounding ICH Q10 Pharmaceutical Quality System is governed by various national and international regulations, including:

  • EU GMP (European Union Good Manufacturing Practice) guidelines

  • US FDA regulations (21 CFR 210-211)

  • Japanese Ministry of Health, Labour and Welfare (MHLW) regulations

    • These regulations require pharmaceutical companies to develop and implement a robust quality management system to ensure the safety, efficacy, and quality of their products. ICH Q10 provides a framework for developing this quality management system.

    Eurolabs laboratory testing services are designed to support pharmaceutical companies in meeting regulatory requirements and industry standards. Our team of experts has extensive knowledge and experience in conducting microbial controls testing for various pharmaceutical products.

    ICH Q10 Pharmaceutical Quality System requires pharmaceutical companies to develop and implement a robust quality management system to ensure the safety, efficacy, and quality of their products. This standard is based on various international standards, including ISO 9001:2015 (Quality Management Systems - Requirements) and ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes).

    The business and technical reasons for conducting ICH Q10 Pharmaceutical Quality System testing include:

  • Ensuring the safety, efficacy, and quality of pharmaceutical products

  • Meeting regulatory requirements and industry standards

  • Developing a robust quality management system to ensure compliance with regulations

  • Reducing the risk of product recalls and customer complaints

    • The consequences of not performing this test include:

  • Non-compliance with regulatory requirements and industry standards

  • Risk of product contamination or adulteration

  • Potential harm to customers due to defective products

  • Loss of reputation and market share

    • ICH Q10 Pharmaceutical Quality System testing is required for various industries, including:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Medical device manufacturers

  • Cosmetic manufacturers

    • Eurolabs laboratory testing services are designed to support pharmaceutical companies in meeting regulatory requirements and industry standards. Our team of experts has extensive knowledge and experience in conducting microbial controls testing for various pharmaceutical products.

    Eurolabs laboratory testing services for ICH Q10 Pharmaceutical Quality System involve the following steps:

    1. Sample collection: Eurolab collects samples from the clients facility or through a third-party service provider.

    2. Sample preparation: Eurolab prepares the samples according to the relevant standard and test method.

    3. Testing: Eurolab conducts microbial controls testing using various methods, including:

    Total viable count (TVC)

    Standard plate count (SPC)

    Yeast and mold count

    Bacterial endotoxin test (BET)

    4. Data analysis: Eurolab analyzes the test results and provides a report to the client.

    Eurolab uses state-of-the-art equipment and facilities to conduct microbial controls testing for ICH Q10 Pharmaceutical Quality System. Our team of experts has extensive knowledge and experience in conducting this type of testing.

    The testing environment requirements include:

  • Temperature: 20-25C (68-77F)

  • Humidity: 50-60

  • Pressure: Atmospheric pressure

    • Eurolabs laboratory is accredited by various national and international accreditation bodies, including ISO 17025:2018 (General requirements for the competence of testing and calibration laboratories).

    Conclusion

    Eurolab provides comprehensive laboratory testing services for ICH Q10 Pharmaceutical Quality System, including microbial controls testing. Our team of experts has extensive knowledge and experience in conducting this type of testing to ensure that pharmaceutical companies comply with regulatory requirements and industry standards.

    Appendix

    The following appendices provide additional information on Eurolabs laboratory testing services for ICH Q10 Pharmaceutical Quality System:

  • Appendix A: List of international standards related to ICH Q10

  • Appendix B: List of national regulations related to ICH Q10

  • Appendix C: Description of Eurolabs laboratory facilities and equipment

  • Appendix D: Description of Eurolabs quality management system

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