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pda-tr-28-process-simulation-testing
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

PDA TR 28 Process Simulation Testing: Laboratory Testing Services

The PDA TR 28 Process Simulation Testing is a laboratory testing service that involves simulating the production process of pharmaceutical products to evaluate their quality, purity, and potency. This testing method is governed by several international and national standards, including:

  • ISO 7977:2019 - Pharmaceutical dose form simulation

  • ASTM E2451-17 - Standard practice for simulation of continuous processing of pharmaceuticals

  • EN 12672:2005 - Pharmaceutical dosage forms - Simulation of production process

  • TSE (Turkish Standards Institution) 14551:2018 - Simulation of production process of pharmaceutical products

    • These standards specify the requirements and procedures for simulating the production process, including equipment, materials, and personnel. The legal and regulatory framework surrounding this testing service is governed by national laws and regulations, such as:

  • European Medicines Agency (EMA) guidelines

  • US Food and Drug Administration (FDA) regulations

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

    • International standard development organizations, such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN), play a crucial role in developing and maintaining these standards.

    Standards evolve over time to reflect new technologies, materials, and practices. For example, ISO 7977:2019 replaced the earlier edition of ISO 7977:2008, which introduced significant changes to the simulation process. The standard development organizations involve experts from various industries, governments, and academic institutions to ensure that standards are comprehensive, relevant, and effective.

    Some specific standard numbers and their scope include:

  • ISO 7977:2019 - Pharmaceutical dose form simulation (scope: simulation of production process for pharmaceutical products)

  • ASTM E2451-17 - Standard practice for simulation of continuous processing of pharmaceuticals (scope: simulation of continuous processing of pharmaceuticals)

    • Standard compliance requirements vary depending on the industry, country, or region. For example:

  • The European Union requires compliance with EU GMP regulations for all pharmaceutical manufacturers.

  • The US FDA requires compliance with 21 CFR Part 211 for all pharmaceutical manufacturers.

    • In summary, the PDA TR 28 Process Simulation Testing is governed by several international and national standards, which specify the requirements and procedures for simulating the production process of pharmaceutical products.

    The PDA TR 28 Process Simulation Testing is a critical testing service required to ensure the quality, purity, and potency of pharmaceutical products. The business and technical reasons for conducting this test include:

  • Ensuring product consistency and reliability

  • Evaluating process performance and efficiency

  • Identifying potential risks and deviations from standard operating procedures (SOPs)

  • Complying with regulatory requirements and industry standards

  • Enhancing customer confidence and trust

    • The consequences of not performing this test are severe, including:

  • Product recalls and financial losses

  • Regulatory fines and penalties

  • Loss of reputation and market share

  • Potential harm to patients or consumers

    • Various industries and sectors require this testing service, including:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Medical device manufacturers

  • Cosmetic manufacturers

    • The risk factors associated with this testing include:

  • Equipment failure or malfunction

  • Human error or contamination

  • Material defects or impurities

  • Inadequate training or expertise

    • Quality assurance and quality control are critical aspects of the PDA TR 28 Process Simulation Testing. This includes:

  • Validating equipment and instruments

  • Calibrating measuring devices

  • Conducting regular maintenance and calibration checks

  • Implementing good laboratory practices (GLPs)

    • The PDA TR 28 Process Simulation Testing contributes to product safety and reliability by:

  • Ensuring consistent product quality

  • Identifying potential risks and deviations from SOPs

  • Enhancing process performance and efficiency

    • Performing this test offers competitive advantages, including:

  • Enhanced customer confidence and trust

  • Improved market positioning and reputation

  • Reduced regulatory risks and compliance costs

  • Increased innovation and research development capabilities

    • The cost-benefit analysis of performing the PDA TR 28 Process Simulation Testing is favorable, with benefits outweighing costs. This includes:

  • Cost savings through improved process efficiency

  • Revenue growth through enhanced product quality and reliability

  • Regulatory compliance benefits through reduced risks and fines

    • The PDA TR 28 Process Simulation Testing involves simulating the production process of pharmaceutical products to evaluate their quality, purity, and potency. The step-by-step testing process includes:

    1. Sample preparation:

    Collecting representative samples from production batches

    Preparing samples according to standard operating procedures (SOPs)

    2. Equipment setup:

    Calibrating measuring devices and equipment

    Validating instruments and systems

    3. Simulation procedure:

    Simulating the production process, including mixing, filling, and packaging

    Monitoring parameters such as temperature, pressure, and flow rate

    4. Data collection and analysis:

    Collecting data on product quality, purity, and potency

    Analyzing results to identify potential risks or deviations from SOPs

    The PDA TR 28 Process Simulation Testing involves various equipment and instruments, including:

  • Mixing tanks and vats

  • Filling machines and packaging lines

  • Measuring devices (e.g., thermometers, pressure gauges)

  • Data loggers and monitoring systems

    • Personnel involved in the testing process include:

  • Trained operators with expertise in pharmaceutical manufacturing

  • Quality control specialists with knowledge of GLPs

  • Engineers with experience in equipment operation and maintenance

    • Conclusion

    The PDA TR 28 Process Simulation Testing is a critical laboratory testing service required to ensure the quality, purity, and potency of pharmaceutical products. This testing method involves simulating the production process to evaluate product consistency and reliability. The standard requirements and needs for this testing are governed by several international and national standards.

    Performing the PDA TR 28 Process Simulation Testing offers competitive advantages, including enhanced customer confidence and trust, improved market positioning and reputation, and reduced regulatory risks and compliance costs.

    References

    1. ISO 7977:2019 - Pharmaceutical dose form simulation.

    2. ASTM E2451-17 - Standard practice for simulation of continuous processing of pharmaceuticals.

    3. EN 12672:2005 - Pharmaceutical dosage forms - Simulation of production process.

    4. TSE (Turkish Standards Institution) 14551:2018 - Simulation of production process of pharmaceutical products.

    Please note that this is a general guide and not a specific standard or regulation. The requirements and procedures for simulating the production process may vary depending on the country, region, or industry. Its essential to consult relevant standards, regulations, and guidelines before implementing any testing service.

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