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dietary supplement cgmp guideline

By Carmen Elliott,2014-12-31 18:23
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dietary supplement cgmp guideline

    CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

    ________________________________________

    Contents

    Subpart AGeneral Provisions

    ? 111.1 Who is subject to this part?

    ? 111.3 What definitions apply to this part?

    ? 111.5 Do other statutory provisions and regulations apply?

    Subpart BPersonnel

    ? 111.8 What are the requirements under this subpart B for written procedures? ? 111.10 What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?

    ? 111.12 What personnel qualification requirements apply?

    ? 111.13 What supervisor requirements apply?

    ? 111.14 Under this subpart B, what records must you make and keep? Subpart CPhysical Plant and Grounds

    ? 111.15 What sanitation requirements apply to your physical plant and grounds? ? 111.16 What are the requirements under this subpart C for written procedures? ? 111.20 What design and construction requirements apply to your physical plant? ? 111.23 Under this subpart C, what records must you make and keep? Subpart DEquipment and Utensils

    ? 111.25 What are the requirements under this subpart D for written procedures? ? 111.27 What requirements apply to the equipment and utensils that you use? ? 111.30 What requirements apply to automated, mechanical, or electronic equipment? ? 111.35 Under this subpart D, what records must you make and keep? Subpart ERequirement to Establish a Production and Process Control System ? 111.55 What are the requirements to implement a production and process control system?

    ? 111.60 What are the design requirements for the production and process control system? ? 111.65 What are the requirements for quality control operations? ? 111.70 What specifications must you establish?

    ? 111.73 What is your responsibility for determining whether established specifications are met?

    ? 111.75 What must you do to determine whether specifications are met? ? 111.77 What must you do if established specifications are not met? ? 111.80 What representative samples must you collect?

    ? 111.83 What are the requirements for reserve samples?

    ? 111.87 Who conducts a material review and makes a disposition decision? ? 111.90 What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with ? 111.70 is not met?

    ? 111.95 Under this subpart E, what records must you make and keep? Subpart FProduction and Process Control System: Requirements for Quality Control ? 111.103 What are the requirements under this subpart F for written procedures?

? 111.105 What must quality control personnel do?

    ? 111.110 What quality control operations are required for laboratory operations associated with the production and process control system?

    ? 111.113 What quality control operations are required for a material review and disposition decision?

    ? 111.117 What quality control operations are required for equipment, instruments, and controls?

    ? 111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?

    ? 111.123 What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?

    ? 111.127 What quality control operations are required for packaging and labeling operations?

    ? 111.130 What quality control operations are required for returned dietary supplements? ? 111.135 What quality control operations are required for product complaints? ? 111.140 Under this subpart F, what records must you make and keep?

    Subpart GProduction and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement ? 111.153 What are the requirements under this subpart G for written procedures? ? 111.155 What requirements apply to components of dietary supplements? ? 111.160 What requirements apply to packaging and labels received?

    ? 111.165 What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier)? ? 111.170 What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement? ? 111.180 Under this subpart G, what records must you make and keep?

    Subpart HProduction and Process Control System: Requirements for the Master Manufacturing Record

    ? 111.205 What is the requirement to establish a master manufacturing record? ? 111.210 What must the master manufacturing record include?

    Subpart IProduction and Process Control System: Requirements for the Batch Production Record

    ? 111.255 What is the requirement to establish a batch production record? ? 111.260 What must the batch record include?

    Subpart JProduction and Process Control System: Requirements for Laboratory Operations ? 111.303 What are the requirements under this subpart J for written procedures? ? 111.310 What are the requirements for the laboratory facilities that you use? ? 111.315 What are the requirements for laboratory control processes? ? 111.320 What requirements apply to laboratory methods for testing and examination? ? 111.325 Under this subpart J, what records must you make and keep?

    Subpart KProduction and Process Control System: Requirements for Manufacturing Operations ? 111.353 What are the requirements under this subpart K for written procedures? ? 111.355 What are the design requirements for manufacturing operations? ? 111.360 What are the requirements for sanitation?

? 111.365 What precautions must you take to prevent contamination?

    ? 111.370 What requirements apply to rejected dietary supplements?

    ? 111.375 Under this subpart K, what records must you make and keep? Subpart LProduction and Process Control System: Requirements for Packaging and Labeling Operations

    ? 111.403 What are the requirements under this subpart L for written procedures? ? 111.410 What requirements apply to packaging and labels?

    ? 111.415 What requirements apply to filling, assembling, packaging, labeling, and related operations?

    ? 111.420 What requirements apply to repackaging and relabeling?

    ? 111.425 What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?

    ? 111.430 Under this subpart L, what records must you make and keep? Subpart MHolding and Distributing

    ? 111.453 What are the requirements under this subpart for M written procedures? ? 111.455 What requirements apply to holding components, dietary supplements, packaging, and labels?

    ? 111.460 What requirements apply to holding in-process material?

    ? 111.465 What requirements apply to holding reserve samples of dietary supplements? ? 111.470 What requirements apply to distributing dietary supplements? ? 111.475 Under this subpart M, what records must you make and keep? Subpart NReturned Dietary Supplements

    ? 111.503 What are the requirements under this subpart N for written procedures? ? 111.510 What requirements apply when a returned dietary supplement is received? ? 111.515 When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

    ? 111.520 When may a returned dietary supplement be salvaged?

    ? 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?

    ? 111.530 When must an investigation be conducted of your manufacturing processes and other batches?

    ? 111.535 Under this subpart N, what records must you make and keep? Subpart OProduct Complaints

    ? 111.553 What are the requirements under this subpart O for written procedures? ? 111.560 What requirements apply to the review and investigation of a product complaint? ? 111.570 Under this subpart O, what records must you make and keep? Subpart PRecords and Recordkeeping

    ? 111.605 What requirements apply to the records that you make and keep? ? 111.610 What records must be made available to FDA?

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